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| Therapy Name | Nivolumab |
| Synonyms | |
| Therapy Description |
Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer (NSCLC) progressed on prior therapies, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma (UC) , esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) for melanoma, renal cell carcinoma (RCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy for PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy for metastatic or recurrent NSCLC without EGFR or ALK alterations, with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, with Cabometyx (cabozantinib) for advanced RCC, with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, and with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic UC (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Nivolumab | Opdivo | MDX-1106|BMS-936558 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 | Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer (NSCLC) progressed on prior therapies, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma (UC) , esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) for melanoma, renal cell carcinoma (RCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy for PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy for metastatic or recurrent NSCLC without EGFR or ALK alterations, with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, with Cabometyx (cabozantinib) for advanced RCC, with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, and with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic UC (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| MSH6 F1088Lfs*5 MSH6 Y1256* MSH6 A1320Sfs*5 | colorectal carcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical case study, Opdivo (nivolumab) treatment resulted in stable disease lasting four months in a colorectal carcinoma patient harboring MSH6 F1088Lfs*5, Y1256*, and A1320Sfs*5 (PMID: 35739269). | 35739269 |
| CD274 neg MSH6 W628* | glioblastoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical case study, Opdivo (nivolumab) treatment resulted in a 60% reduction of tumor size and durable clinical response that was still ongoing after 10 months in a pediatric patient with refractory glioblastoma that was CD274 (PD-L1) negative, the patient was also diagnosed with constitutional mismatch repair-deficiency (CMMRD) syndrome due to biallelic MSH6 W628* mutation (PMID: 30104292). | 30104292 |
| POLE P286R | colorectal cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a retrospective study, treatment with immune checkpoint inhibitors resulted in an overall response rate of 89% (22/29) and a disease control rate of 92% in metastatic colorectal cancer patients harboring pathogenic POLE/POLD1 variants, including a complete response in a patient harboring POLE P286R treated with Opdivo (nivolumab) (PMID: 38777726). | 38777726 |
| POLE P286R | colorectal cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in a complete response in a colorectal cancer patient harboring POLE P286R, along with high tumor mutational burden and CD8-positive high tumor infiltrating lymphocytes, and a partial response in a different colorectal cancer patient also harboring POLE P286R, along with high tumor mutational burden (PMID: 35398880; NCT03012581). | 35398880 |
| POLE D435G | colorectal cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in a partial response in a colorectal cancer patient harboring POLE D435G (PMID: 35398880; NCT03012581). | 35398880 |
| CD274 positive | transitional cell carcinoma | predicted - sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial (CheckMate 275), Opdivo (nivolumab) treatment in platinum-resistant urothelial carcinoma patients resulted in an objective response rate (ORR) of 20.7% (56/270), a median progression-free survival (mPFS) of 1.9 mo., and a median overall survival (mOS) of 8.6 mo., and patients with CD274 (PD-L1)-positive tumors (IHC>=1% compared to <1%) had improved ORR (25.8%, 32/124 v 16.4%, 24/146), mPFS (3.5 v 1.9 mo), and mOS (11.9 v 6.0 mo) (PMID: 32532789; NCT02387996). | 32532789 |
| CD274 positive | transitional cell carcinoma | predicted - sensitive | Nivolumab | Phase III | Actionable | In a Phase III trial (CheckMate-274), adjuvant Opdivo (nivolumab) treatment significantly improved the percentage of patients who were alive and disease-free at 6 months (74.5% vs 55.7%, HR 0.55, P<0.001) and median recurrence-free survival (22.9 vs 13.7 mo) compared to placebo in patients with high-risk urothelial carcinoma with a PD-L1 expression level of 1% or more (PMID: 34077643; NCT02632409). | 34077643 |
| MSH2 negative | endometrial carcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a second-line or subsequent-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent endometrial carcinoma (NCCN.org). | detail... |
| MSH2 negative | endometrial carcinoma | sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, Opdivo (nivolumab) treatment resulted in an objective response rate of 58.8% (20/34, 7 complete and 13 partial responses) and a progression-free survival rate at 24 mo of 64.7% in patients with MSI-high or deficient mismatch repair (dMMR defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) ovarian or endometrial carcinoma, including responses in 2 patients with uterine clear cell carcinoma and 1 patient with ovarian clear cell carcinoma (PMID: 38653864; NCT03241745). | 38653864 |
| PMS2 negative | endometrial carcinoma | sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, Opdivo (nivolumab) treatment resulted in an objective response rate of 58.8% (20/34, 7 complete and 13 partial responses) and a progression-free survival rate at 24 mo of 64.7% in patients with MSI-high or deficient mismatch repair (dMMR defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) ovarian or endometrial carcinoma, including responses in 2 patients with uterine clear cell carcinoma and 1 patient with ovarian clear cell carcinoma (PMID: 38653864; NCT03241745). | 38653864 |
| PMS2 negative | endometrial carcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a second-line or subsequent-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent endometrial carcinoma (NCCN.org). | detail... |
| CD274 positive | melanoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, PD-L1 (CD274) expression in primary melanomas, but not the PD-L1 status of advancing edges or metastases, was associated with higher 6-month objective response rate (35.7% in PD-L1 positive vs. 5% in PD-L1 negative; p=0.02) following treatment with Keytruda (pembrolizumab) or Opdivo (nivolumab) in patients with metastatic melanoma (PMID: 29973670). | 29973670 |
| ARID1A mutant | bladder urothelial carcinoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, metastatic urothelial carcinoma patients from the CheckMate275 trial harboring an ARID1A mutation (n=39) demonstrated a greater overall survival (11.4 mo vs 6.0 mo; P=0.03) compared to patients with wild-type ARID1A (n=100) when treated with Opdivo (nivolumab) (PMID: 32554706; NCT02387996). | 32554706 |
| IDH1 wild-type PTEN mut | glioblastoma | resistant | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, PTEN mutations were significantly enriched in patients with IDH1 wild-type glioblastoma who did not respond to anti-PD-1 therapy with either Keytruda (pembrolizumab) or Opdivo (nivolumab), compared to those who responded (odds ratio=0.85, p=0.0063), with 23 PTEN mutations identified in 32 non-responders and 3 in 13 responders (PMID: 30742119). | 30742119 |
| MLH1 negative | small intestine adenocarcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| POLE V411L | endometrial cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in a partial response in two patients with endometrial cancer harboring POLE V411L, along with high tumor mutational burden (PMID: 35398880; NCT03012581). | 35398880 |
| POLE inact mut | Advanced Solid Tumor | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in an objective response rate (ORR) of 38% (7/19; all partial responses) and a disease control rate (DCR) of 58% (11/19) at 12 weeks in patients with advanced solid tumors harboring a POLE mutation, and among assessable patients with an inactivating POLE mutation, along with high tumor mutational burden, treatment resulted in an ORR of 46% (5/11) and a DCR of 73% (8/11) (PMID: 35398880; NCT03012581). | 35398880 |
| CD274 positive | renal cell carcinoma | predicted - sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial (HCRN GU16-260), Opdivo (nivolumab) treatment in patients with CD274 (PD-L1)-positive treatment-naive advanced clear cell renal cell carcinoma resulted in an objective response rate (ORR) 50% (8/16) in patients with CD274 (PD-L1) expression between 1% to 20% and an ORR of 75% (6/8), median progression-free survival (PFS) of 20.6 months, and 1-year PFS rate of 75% in patients with CD274 (PD-L1) expression of 20% or higher (PMID: 35442713; NCT03117309). | 35442713 |
| MSH2 negative | colon cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as primary or subsequent therapy for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| BRAF V600E | melanoma | decreased response | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, patients with melanoma harboring BRAF V600E (n=84) had decreased response rates (29% vs. 53%, p=0.059), progression-free survival (2.7 vs. 19 months, p=0.049), and overall survival (11.7 vs. 20.4 months, p=0.081) relative to patients with BRAF V600K (n=19) when treated with Keytruda (pembrolizumab) (n=62 and 17 for BRAF V600E and V600K, respectively) or Opdivo (nivolumab) (n=22 and 2 for BRAF V600E and V600K, respectively) (PMID: 30630828). | 30630828 |
| CD274 positive | biliary tract cancer | sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, baseline CD274 (PD-L1) expression was associated with increased median progression-free survival (PFS) in biliary tract cancer patients treated with Opdivo (nivolumab) compared to patients without CD274 (PD-L1) expression, with a median PFS of 19.8 months vs 2.4 months (P=0.0001) and 12-month PFS rate of 61% vs 5%, respectively (PMID: 36252287; NCT02829918). | 36252287 |
| POLD1 inact mut | small intestine adenocarcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma harboring POLD1 inactivating mutations (NCCN.org). | detail... |
| MSH6 negative | endometrial cancer | sensitive | Nivolumab | Guideline | Actionable | Immune checkpoint inhibitor monotherapy including Opdivo (nivolumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent or metastatic endometrial cancer who have failed prior platinum-based chemotherapy (PMID: 36696825; ESMO.org). | detail... 36696825 |
| BRAF V600K | melanoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, patients with melanoma harboring BRAF V600K (n=19) had increased tumor mutational burden and greater response rates (53% vs. 29%, p=0.059), progression-free survival (19 vs. 2.7 months, p=0.049), and overall survival (20.4 vs. 11.7 months, p=0.081) relative to patients with BRAF V600E (n=84) when treated with Keytruda (pembrolizumab) (n=17 and 62 for BRAF V600K and V600E, respectively) or Opdivo (nivolumab) (n=2 and 22 for BRAF V600K and V600E, respectively) (PMID: 30630828). | 30630828 |
| MSH6 negative | endometrial carcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a second-line or subsequent-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent endometrial carcinoma (NCCN.org). | detail... |
| MSH6 negative | endometrial carcinoma | sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, Opdivo (nivolumab) treatment resulted in an objective response rate of 58.8% (20/34, 7 complete and 13 partial responses) and a progression-free survival rate at 24 mo of 64.7% in patients with MSI-high or deficient mismatch repair (dMMR defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) ovarian or endometrial carcinoma, including responses in 2 patients with uterine clear cell carcinoma and 1 patient with ovarian clear cell carcinoma (PMID: 38653864; NCT03241745). | 38653864 |
| MSH2 negative | Advanced Solid Tumor | predicted - sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial (NCI-MATCH), Opdivo (nivolumab) treatment demonstrated preliminary efficacy in advanced solid tumor patients (excluding colorectal cancer) with deficient mismatch repair (defined by the loss of MLH1 or MSH2 expression by IHC), resulting in an objective response rate of 36% (15/42, 3 complete and 12 partial responses), a median progression-free survival (PFS) of 6.3 mo, a 6-month PFS rate of 51.3%, and a median overall survival of 17.3 months (PMID: 31765263; NCT02465060). | 31765263 |
| MLH1 negative | Advanced Solid Tumor | predicted - sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial (NCI-MATCH), Opdivo (nivolumab) treatment demonstrated preliminary efficacy in advanced solid tumor patients (excluding colorectal cancer) with deficient mismatch repair (defined by the loss of MLH1 or MSH2 expression by IHC), resulting in an objective response rate of 36% (15/42, 3 complete and 12 partial responses), a median progression-free survival (PFS) of 6.3 mo, a 6-month PFS rate of 51.3%, and a median overall survival of 17.3 months (PMID: 31765263; NCT02465060). | 31765263 |
| MSH2 negative | endometrial cancer | sensitive | Nivolumab | Guideline | Actionable | Immune checkpoint inhibitor monotherapy including Opdivo (nivolumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent or metastatic endometrial cancer who have failed prior platinum-based chemotherapy (PMID: 36696825; ESMO.org). | detail... 36696825 |
| PBRM1 inact mut | clear cell renal cell carcinoma | sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, renal clear cell carcinoma patients harboring PBRM1 loss-of-function mutations demonstrated improved response to immune checkpoint therapies including Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab), and Tecentriq (atezolizumab), potentially due to the distinct expression profile of immune-related genes in these patients (PMID: 29301960). | 29301960 |
| FGFR3 mutant | transitional cell carcinoma | no benefit | Nivolumab | Phase II | Actionable | In a Phase II trial (CheckMate 275), Opdivo (nivolumab) (n=270) treatment resulted in similar response rate (20% vs 21%, p=0.2) in patients with FGFR3 mutant or wild-type metastatic transitional cell carcinoma (PMID: 31272788). | 31272788 |
| CD274 amp | basal cell carcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical case study, a patient with metastatic basal cell carcinoma harboring CD274 amplification and a high mutational burden was sensitive to treatment with Opdivo (nivolumab), demonstrating reduced lesion size after two months of treatment and a nearly complete regression of liver lesions after four months of treatment (PMID: 27942391). | 27942391 |
| POLE A463V | endometrial cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in stable disease in a patient with endometrial cancer harboring POLE A463V, along with high tumor mutational burden (PMID: 35398880; NCT03012581). | 35398880 |
| MSH2 negative | cholangiocarcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial (NCI-MATCH), Opdivo (nivolumab) treatment demonstrated preliminary efficacy in advanced solid tumor patients (excluding colorectal cancer) with deficient mismatch repair (defined by the loss of MLH1 or MSH2 expression by IHC), resulting in an objective response rate of 36% (15/42, 3 complete and 12 partial responses), including 1 complete response and 1 stable disease in two patients with cholangiocarcinoma (PMID: 31765263; NCT02465060). | 31765263 |
| POLE V464A | colorectal cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in a durable complete response in a colorectal cancer patient harboring POLE V464A, along with high tumor mutational burden (PMID: 35398880; NCT03012581). | 35398880 |
| PMS2 negative | endometrial cancer | sensitive | Nivolumab | Guideline | Actionable | Immune checkpoint inhibitor monotherapy including Opdivo (nivolumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent or metastatic endometrial cancer who have failed prior platinum-based chemotherapy (PMID: 36696825; ESMO.org). | detail... 36696825 |
| MLH1 negative | endometrial carcinoma | sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, Opdivo (nivolumab) treatment resulted in an objective response rate of 58.8% (20/34, 7 complete and 13 partial responses) and a progression-free survival rate at 24 mo of 64.7% in patients with MSI-high or deficient mismatch repair (dMMR defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) ovarian or endometrial carcinoma, including responses in 2 patients with uterine clear cell carcinoma and 1 patient with ovarian clear cell carcinoma (PMID: 38653864; NCT03241745). | 38653864 |
| MLH1 negative | endometrial carcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a second-line or subsequent-line therapy for patients with high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent endometrial carcinoma (NCCN.org). | detail... |
| PTEN mutant | gastrointestinal system cancer | decreased response | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, patients with MSI high, dMMR gastrointestinal tumors including gastric (n=18), colorectal (n=17), cholangiocarcinoma (n=5), small intestine (n=2), pancreatic (n=2), and duodenal cancer (n=1) harboring PTEN mutations demonstrated a decreased objective response rate (21.4 vs 54.8%), overall survival (15.2 vs 25.7 mo), and progression-free survival (4.3 vs 15.6 mo) compared to PTEN-wild-type patients when treated with Keytruda (pembrolizumab) or Opdivo (nivolumab) (PMID: 33926917). | 33926917 |
| PMS2 negative | colon cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as primary or subsequent therapy for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| POLE P286R | endometrial cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in stable disease in an endometrial cancer patient harboring POLE P286R, along with high tumor mutational burden (PMID: 35398880; NCT03012581). | 35398880 |
| PBRM1 K154fs | clear cell renal cell carcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in partial response in a patient with renal clear cell carcinoma harboring PBRM1 K154fs (PMID: 29301960). | 29301960 |
| CD274 positive | esophageal cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy is included in guidelines as first-line therapy for patients with advanced, untreated esophageal cancer expressing PD-L1 (CD274, CPS>=5) (PMID: 35914639; ESMO.org). | 35914639 detail... |
| MSH2 negative | small intestine adenocarcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| CD274 positive | gastroesophageal junction adenocarcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy is included in guidelines as first-line therapy for patients with advanced, untreated gastroesophageal junction adenocacinoma expressing PD-L1 (CD274, CPS>=5) (PMID: 35914639; ESMO.org). | detail... 35914639 |
| PMS2 negative | colorectal cancer | sensitive | Nivolumab | FDA approved | Actionable | In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) of patients with microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) metastatic colorectal cancer (PMID: 28734759; NCT02060188). | 28734759 detail... detail... |
| TP53 mutant | lung non-small cell carcinoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, immune checkpoint inhibitor treatment including Keytruda (pembrolizumab) (n=1), Opdivo (nivolumab) with (n=8) or without (n=63) Yervoy (ipilimumab) resulted in improved median overall survival (18.1 vs 8.1 months, HR=0.48, p=0.04), median progression-free survival (4.5 vs 1.4 months, p=0.03), and objective response rate (51.2% vs 20.7%, p=0.01) in TP53 mutant (n=41) non-small cell lung cancer patients compared to TP53 wild-type (n=31) patients (PMID: 31097096). | 31097096 |
| POLE N363K | endometrial cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in stable disease in an endometrial cancer patient harboring POLE N363K, along with high tumor mutational burden (PMID: 35398880; NCT03012581). | 35398880 |
| MSH6 negative | colon cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as primary or subsequent therapy for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| NRAS mutant | melanoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, NRAS mutations were associated with higher 6-month objective response rate (53.3% vs. 19.6% without NRAS mutations; p=0.019) following treatment with Keytruda (pembrolizumab) or Opdivo (nivolumab) in patients with metastatic melanoma, however, progression-free survival and overall survival were similar between patients with and without NRAS mutations (PMID: 29973670). | 29973670 |
| PBRM1 N463fs | clear cell renal cell carcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in partial response in a patient with renal clear cell carcinoma harboring PBRM1 N463fs (PMID: 29301960). | 29301960 |
| CD274 amp | lung non-small cell carcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical case study, a CD274 (PD-L1) amplified non-small cell lung carcinoma patient treated with Opdivo (nivolumab) achieved stable disease with a 20% reduction in tumor growth and a progression-free survival of 9.7 months (PMID: 32955570). | 32955570 |
| CD274 amp | lung non-small cell carcinoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, treatment with Opdivo (nivolumab) did not result in a significant overall response rate (ORR) in non-small cell lung cancer (NSCLC) patients with a CD274 copy number gain (CNG; amplification and polysomy) vs patients without a CNG (28.1% vs. 17.9%; p=0.22), but NSCLC patients with CD274 amplification demonstrated an ORR of 80% (4/5), a 1-year progression-free survival of 80%, a 1-year overall survival of 100%, and the median duration of response was not yet reached (PMID: 32955570). | 32955570 |
| PBRM1 S681R | clear cell renal cell carcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in partial response in a patient with renal clear cell carcinoma harboring PBRM1 S681R (PMID: 29301960). | 29301960 |
| PBRM1 K135fs | clear cell renal cell carcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in stable disease in a patient with renal clear cell carcinoma harboring PBRM1 K135fs (PMID: 29301960). | 29301960 |
| MSH6 negative | colorectal cancer | sensitive | Nivolumab | FDA approved | Actionable | In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) of patients with microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) metastatic colorectal cancer (PMID: 28734759; NCT02060188). | 28734759 detail... detail... |
| CD274 positive | lung non-squamous non-small cell carcinoma | sensitive | Nivolumab | Phase III | Actionable | In a Phase III trial (CheckMate 057), Opdivo (nivolumab) treatment demonstrated greater overall survival, progression-free survival, and objective response rate at all CD274 (PD-L1) expression levels analyzed (1% or more, 5% or more, 10% and more) in nonsquamous non-small cell lung carcinoma patients (PMID: 26412456; NCT01673867). | 26412456 |
| BRAF V600E | lung non-small cell carcinoma | not predictive | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, non-small cell lung cancer patients harboring BRAF V600E did not demonstrate a significantly different response to treatment with either Keytruda (pembrolizumab), Opdivo (nivolumab), or Tecentriq (atezolizumab), compared to patients with BRAF non-V600E mutations, demonstrating an objective response rate of 25% (3/12) vs 33% (3/9) (p=1.0) and median progression-free survival of 3.7 months vs 4.1 months (p=0.37) (PMID: 29723688). | 29723688 |
| MLH1 negative | colorectal cancer | sensitive | Nivolumab | FDA approved | Actionable | In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) of patients with microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) metastatic colorectal cancer (PMID: 28734759; NCT02060188). | detail... 28734759 detail... |
| PBRM1 Y608fs | clear cell renal cell carcinoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in progressive disease in a patient with renal clear cell carcinoma harboring PBRM1 Y608fs (PMID: 29301960). | 29301960 |
| POLD1 inact mut | colon cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as systemic therapy for patients with advanced or metastatic colon cancer harboring POLD1 inactivating mutations (NCCN.org). | detail... |
| CD274 positive | glioblastoma | no benefit | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, response to Keytruda (pembrolizumab) or Opdivo (nivolumab) therapy was not predicted by RNA expression levels of CD274 (PD-L1) in glioblastoma patients (PMID: 30742119). | 30742119 |
| POLE inact mut | rectum cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as systemic therapy for patients with advanced or metastatic rectal cancer harboring POLE inactivating mutations (NCCN.org). | detail... |
| POLE G330R | biliary tract cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in stable disease in a biliary tract cancer patient harboring POLE G330R (PMID: 35398880; NCT03012581). | 35398880 |
| PBRM1 Y331* | clear cell renal cell carcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in complete response in a patient with renal clear cell carcinoma harboring PBRM1 Y331* (PMID: 29301960). | 29301960 |
| ALK rearrange | lung non-small cell carcinoma | no benefit | Nivolumab | Guideline | Actionable | Immune checkpoint inhibitors including Opdivo (nivolumab), Keytruda (pembrolizumab), Tecentriq (atezolizumab), and Imfinzi (durvalumab) are not indicated for use as subsequent therapy in non-small cell lung cancer patients with ALK rearrangement (NCCN.org). | detail... |
| ALK rearrange | lung non-small cell carcinoma | no benefit | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, PD-1/PD-L1 inhibitors (Opdivo (nivolumab), Keytruda (pembrolizumab), Durvalumab (MEDI4736), or Tecentriq (atezolizumab)) resulted in lower objective response rate (3.6%, 1/28) in non-small cell lung cancer patients harboring EGFR mutations (22/28) or ALK rearrangement (6/28) compared to EGFR wild-type, ALK negative/unknown patients (23.3%, 7/30) (PMID: 27225694). | 27225694 |
| CD274 positive | vaginal carcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as second-line or subsequent therapy for patients with recurrent or metastatic vaginal squamous cell carcinoma or adenocarcinoma with CD274 (PD-L1) expression (CPS >/= 1) (NCCN.org). | detail... |
| BRAF mut IDH1 wild-type | glioblastoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, MAPK pathway mutations were significantly enriched in patients with IDH1 wild-type glioblastoma who responded to anti-PD-1 therapy with either Keytruda (pembrolizumab) or Opdivo (nivolumab), compared to those who did not respond (odds ratio=12.8, p=0.019), with 4 MAPK pathway mutations (2 in BRAF, 2 in PTPN11) identified in 13 responders and 1 (BRAF) in 32 non-responders (PMID: 30742119). | 30742119 |
| PMS2 negative | rectum cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a primary therapy for advanced or metastatic rectum cancer patients with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| CD274 positive | lung non-small cell carcinoma | no benefit | Nivolumab | Phase III | Actionable | In a Phase III trial, treatment with Opdivo (nivolumab) did not result in longer median progression-free survival (PFS) or overall survival (OS) than chemotherapy treatment in patients with stage IV or recurrent non-small cell lung cancer with PD-L1 (CD274) expression of greater than 5%, resulting in a median PFS of 4.2 mo vs. 5.9 mo with chemotherapy (HR=1.15; 95% CI 0.91-1.45; p=0.25) and a median OS of 14.4 mo vs. 13.2 mo with chemotherapy (HR=1.15; 95% CI 0.80-1.30) (PMID: 28636851; NCT02041533). | 28636851 |
| POLE inact mut | colon cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as systemic therapy for patients with advanced or metastatic colon cancer harboring POLE inactivating mutations (NCCN.org). | detail... |
| PBRM1 K621* | clear cell renal cell carcinoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in progressive disease in a patient with renal clear cell carcinoma harboring PBRM1 K621* (PMID: 29301960). | 29301960 |
| MSH2 negative | rectum cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a primary therapy for advanced or metastatic rectum cancer patients with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| CD274 positive | cervical cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as second-line therapy for patients with CD274 (PD-L1)-positive cervical cancer (NCCN.org). | detail... |
| PBRM1 N609fs | clear cell renal cell carcinoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in progressive disease in a patient with renal clear cell carcinoma harboring PBRM1 N609fs (PMID: 29301960). | 29301960 |
| MLH1 negative | cholangiocarcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial (NCI-MATCH), Opdivo (nivolumab) treatment demonstrated preliminary efficacy in advanced solid tumor patients (excluding colorectal cancer) with deficient mismatch repair (defined by the loss of MLH1 or MSH2 expression by IHC), resulting in an objective response rate of 36% (15/42, 3 complete and 12 partial responses), including 1 complete response and 1 stable disease in two patients with cholangiocarcinoma (PMID: 31765263; NCT02465060). | 31765263 |
| PBRM1 mutant | clear cell renal cell carcinoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, PBRM1 truncating mutations were associated with response to Opdivo (nivolumab) with 39% (15/38) of responding patients harboring PBRM1 mutations vs 22% (16/74) of non-responders, as well as clinical benefit (p=0.0497), increased progression-free survival (HR=0.67), and overall survival (HR=0.65) in post-hoc analysis of archival samples from a Phase III clinical trial of clear cell renal cell carcinoma patients (PMID: 31486842). | 31486842 |
| CD274 positive | esophagus squamous cell carcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy is included in guidelines as first-line therapy for patients with advanced esophageal squamous carcinoma expressing PD-L1 (CD274, TPS>=1%) (PMID: 35914638; ESMO.org). | detail... 35914638 |
| PBRM1 W141_L145delinsC | clear cell renal cell carcinoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in progressive disease in a patient with renal clear cell carcinoma harboring PBRM1 W141_L145delinsC (PMID: 29301960). | 29301960 |
| MLH1 negative | endometrial cancer | sensitive | Nivolumab | Guideline | Actionable | Immune checkpoint inhibitor monotherapy including Opdivo (nivolumab) is included in the Pan-Asian Guidelines Adaptation (PAGA) for patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) recurrent or metastatic endometrial cancer who have failed prior platinum-based chemotherapy (PMID: 36696825; ESMO.org). | detail... 36696825 |
| PMS2 negative | ovarian carcinoma | predicted - sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, Opdivo (nivolumab) treatment resulted in an objective response rate of 58.8% (20/34, 7 complete and 13 partial responses) and a progression-free survival rate at 24 mo of 64.7% in patients with MSI-high or deficient mismatch repair (dMMR defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) ovarian or endometrial carcinoma, including responses in 2 patients with uterine clear cell carcinoma and 1 patient with ovarian clear cell carcinoma (PMID: 38653864; NCT03241745). | 38653864 |
| PMS2 negative | small intestine adenocarcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | rectum cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a primary therapy for advanced or metastatic rectum cancer patients with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MLH1 negative | colon cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as primary or subsequent therapy for patients with advanced or metastatic colon cancer with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MDM2 amp | endometrial stromal sarcoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical case study, a patient with endometrial stromal sarcoma that harbored MDM2 amplification quickly progressed after receiving Opdivo (nivolumab), resulted in new abdominal metastasis and a 242% increase of existing liver metastasis size within 1.5 months of treatment (PMID: 28351930). | 28351930 |
| CD274 positive | malignant spindle cell melanoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, PD-1 blockade therapies including Keytruda (pembrolizumab), Opdivo (nivolumab), and BMS-936559 (alone or in combination) resulted in complete response in 32% (19/60), and partial response in 38% (23/60) of malignant spindle cell melanoma patients, whose tumors contained a high percentage of CD274-positive cells (PMID: 29320474). | 29320474 |
| B2M negative | melanoma | predicted - resistant | Nivolumab | Case Reports/Case Series | Actionable | In a clinical case study, loss of B2m protein expression was identified during and after disease progression in a melanoma patient harboring B2M loss of heterozygosity (LOH), whose disease briefly responded to Opdivo (nivolumab) treatment (PMID: 29070816). | 29070816 |
| PBRM1 G2fs | clear cell renal cell carcinoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in progressive disease in a patient with renal clear cell carcinoma harboring PBRM1 G2fs (PMID: 29301960). | 29301960 |
| BRAF wild-type | melanoma | predicted - sensitive | Nivolumab | Phase III | Actionable | In a Phase III trial (CheckMate-066), Opdivo (nivolumab) treatment resulted in improved overall survival and response compared to treatment with Deticene (dacarbazine) in melanoma patients with wild-type BRAF, including a 3-year overall survival (OS) rate of 51.2% vs. 21.6%, a median OS of 37.5 months vs. 11.2 months, a complete response in 19% (40/210) vs. 1.4% (3/208), and a partial response in 23.8% (50/210) vs. 13% (27/208), respectively (PMID: 30422243; NCT01721772). | 30422243 |
| MSH6 negative | ovarian carcinoma | predicted - sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, Opdivo (nivolumab) treatment resulted in an objective response rate of 58.8% (20/34, 7 complete and 13 partial responses) and a progression-free survival rate at 24 mo of 64.7% in patients with MSI-high or deficient mismatch repair (dMMR defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) ovarian or endometrial carcinoma, including responses in 2 patients with uterine clear cell carcinoma and 1 patient with ovarian clear cell carcinoma (PMID: 38653864; NCT03241745). | 38653864 |
| MLH1 negative | endometrial adenocarcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial (NCI-MATCH), Opdivo (nivolumab) treatment demonstrated preliminary efficacy in advanced solid tumor patients (excluding colorectal cancer) with deficient mismatch repair (defined by the loss of MLH1 or MSH2 expression by IHC), resulting in an objective response rate of 36% (15/42, 3 complete and 12 partial responses), including 2 complete responses and 2 partial responses in patients with endometrioid endometrial adenocarcinoma (n=13) (PMID: 31765263; NCT02465060). | 31765263 |
| PBRM1 E291* | clear cell renal cell carcinoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in progressive disease in a patient with renal clear cell carcinoma harboring PBRM1 E291* (PMID: 29301960). | 29301960 |
| CD274 positive | stomach cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-based chemotherapy is included in guidelines as first-line therapy for patients with advanced, untreated gastric cancer expressing PD-L1 (CD274, CPS>=5) (PMID: 35914639; ESMO.org). | detail... 35914639 |
| CD274 positive | stomach cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab), in combination with first-line chemotherapy including fluoropyrimidine and oxaliplatin, is included in guidelines as preferred first-line therapy for patients with gastric cancer expressing PD-L1 (CD274, CPS>=5), and without ERBB2 (HER2) overexpression (category 1), and as first-line therapy for patients with PD-L1 expression (CD274, CPS <5) and without ERBB2 (HER2) overexpression (category 2B) (NCCN.org). | detail... |
| MSH2 negative | colorectal cancer | sensitive | Nivolumab | FDA approved | Actionable | In a Phase II trial (CheckMate 142) that supported FDA approval, treatment with Opdivo (nivolumab) resulted in an objective response rate of 36% (19/53, 1 complete response, 18 partial responses) and disease control for 12 weeks or more in 70% (37/53) of patients with microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR, defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) metastatic colorectal cancer (PMID: 28734759; NCT02060188). | 28734759 detail... detail... |
| MLH1 negative | ovarian carcinoma | predicted - sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, Opdivo (nivolumab) treatment resulted in an objective response rate of 58.8% (20/34, 7 complete and 13 partial responses) and a progression-free survival rate at 24 mo of 64.7% in patients with MSI-high or deficient mismatch repair (dMMR defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) ovarian or endometrial carcinoma, including responses in 2 patients with uterine clear cell carcinoma and 1 patient with ovarian clear cell carcinoma (PMID: 38653864; NCT03241745). | 38653864 |
| PTEN positive | melanoma | sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, melanoma patients with PTEN positive tumors demonstrated a decrease in tumor size when treated with Opdivo (nivolumab) (PMID: 26645196). | 26645196 |
| CD274 over exp | lung non-small cell carcinoma | predicted - sensitive | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, non-small cell lung carcinoma patients with a CD274 (PD-L1) TPS of >=50% treated with Opdivo (nivolumab) achieved an overall response rate of 45.8% vs. 15.9% (p=0.002) and a median progression-free survival of 8.1 months vs. 2.2 months (HR=0.54; 95% CI: 0.33-0.90; p=0.02), and demonstrated an overall survival benefit (HR=0.44; 95% CI: 0.23-0.84; p=0.01) compared to patients with a TPS of < 50% (PMID: 32955570). | 32955570 |
| CD274 over exp | lung non-small cell carcinoma | predicted - sensitive | Nivolumab | Clinical Study - Meta-analysis | Actionable | In a meta-analysis, treatment with immune checkpoint inhibitors including Tecentriq (atezolizumab), Opdivo (nivolumab), Yervoy (ipilimumab), and Keytruda (pembrolizumab) resulted in improved progression-free survival (HR=0.41, p<0.001) and overall survival (HR=0.62, p=0.006) in non-small cell lung cancer patients with high CD274 (PD-L1) expression compared to patients with low CD274 (PD-L1) expression (PMID: 31290993). | 31290993 |
| PTEN dec exp | melanoma | decreased response | Nivolumab | Clinical Study - Cohort | Actionable | In a clinical study, melanoma patients with PTEN expression in less than 10% of tumor cells demonstrated decreased response to anti-PD-1 antibodies, including Opdivo (nivolumab), as compared to patients in which PTEN is present in over 10% of tumor cells (PMID: 26645196). | 26645196 |
| POLE inact mut | small intestine adenocarcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma harboring POLE inactivating mutations (NCCN.org). | detail... |
| MSH2 negative | endometrial adenocarcinoma | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial (NCI-MATCH), Opdivo (nivolumab) treatment demonstrated preliminary efficacy in advanced solid tumor patients (excluding colorectal cancer) with deficient mismatch repair (defined by the loss of MLH1 or MSH2 expression by IHC), resulting in an objective response rate of 36% (15/42, 3 complete and 12 partial responses), including 2 complete responses and 2 partial responses in patients with endometrioid endometrial adenocarcinoma (n=13) (PMID: 31765263; NCT02465060). | 31765263 |
| MLH1 negative | rectum cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as a primary therapy for advanced or metastatic rectum cancer patients with high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| POLD1 inact mut | rectum cancer | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as systemic therapy for patients with advanced or metastatic rectal cancer harboring POLD1 inactivating mutations (NCCN.org). | detail... |
| POLE S459F | colorectal cancer | predicted - sensitive | Nivolumab | Case Reports/Case Series | Actionable | In a Phase II trial, Opdivo (nivolumab) resulted in a durable partial response in a colorectal cancer patient harboring POLE S459F, along with high tumor mutational burden (PMID: 35398880; NCT03012581). | 35398880 |
| MSH2 negative | ovarian carcinoma | predicted - sensitive | Nivolumab | Phase II | Actionable | In a Phase II trial, Opdivo (nivolumab) treatment resulted in an objective response rate of 58.8% (20/34, 7 complete and 13 partial responses) and a progression-free survival rate at 24 mo of 64.7% in patients with MSI-high or deficient mismatch repair (dMMR defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) ovarian or endometrial carcinoma, including responses in 2 patients with uterine clear cell carcinoma and 1 patient with ovarian clear cell carcinoma (PMID: 38653864; NCT03241745). | 38653864 |
| MSH6 negative | small intestine adenocarcinoma | sensitive | Nivolumab | Guideline | Actionable | Opdivo (nivolumab) is included in guidelines as an initial therapy for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, PMS2, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| PBRM1 A249fs | clear cell renal cell carcinoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in progressive disease in a patient with renal clear cell carcinoma harboring PBRM1 A249fs (PMID: 29301960). | 29301960 |
| BRAF mut CD274 pos | lung non-small cell carcinoma | not predictive | Nivolumab | Clinical Study - Cohort | Actionable | In a retrospective analysis, BRAF mutant non-small cell lung cancer patients with CD274 (PD-L1) expression >/= 50% did not show a significantly different response to treatment with either Keytruda (pembrolizumab), Opdivo (nivolumab), or Tecentriq (atezolizumab) when compared to BRAF mutant patients with CD274 (PD-L1) expression, 0-49%, demonstrating an objective response rate of 36% (4/11) vs 14% (1/7) (p=0.59) and median progression-free survival of 5.3 mo vs 2.2 mo (p=0.73) (PMID: 29723688). | 29723688 |
| PBRM1 R941fs | clear cell renal cell carcinoma | no benefit | Nivolumab | Case Reports/Case Series | Actionable | In a clinical study, Opdivo (nivolumab) treatment resulted in progressive disease in a patient with renal clear cell carcinoma harboring PBRM1 R941fs (PMID: 29301960). | 29301960 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03718767 | Phase II | Nivolumab | Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype | Recruiting | USA | 0 |
| NCT04612530 | Phase I | Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Nivolumab IMO-2125 + Nivolumab | PANFIRE-3 Trial: Assessing Safety and Efficacy of Irreversible Electroporation (IRE) + Nivolumab + CpG for Metastatic Pancreatic Cancer | Unknown status | NLD | 0 |
| NCT02532231 | Phase II | Nivolumab | Nivolumab in AML in Remission at High Risk for Relapse | Completed | USA | 0 |
| NCT03770299 | Phase II | Docetaxel Nivolumab Paclitaxel Cisplatin Carboplatin Gemcitabine Pemetrexed Disodium Vinorelbine | An Investigational Immuno-therapy Study of Nivolumab Given After Surgery in Non-Small Cell Lung Cancer (NSCLC) Participants With Minimal Residual Disease (CheckMate 9TN) | Withdrawn | 0 | |
| NCT02423954 | Phase Ib/II | Temsirolimus Nivolumab Capecitabine Irinotecan | Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus) | Terminated | USA | 0 |
| NCT04021420 | Phase Ib/II | Nivolumab | Safety and Efficacy of Sonocloud Device Combined With Nivolumab in Brain Metastases From Patients With Melanoma (SONIMEL01) | Unknown status | FRA | 0 |
| NCT02726581 | Phase III | Elotuzumab Nivolumab Dexamethasone + Pomalidomide | Study of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Multiple Myeloma | Completed | USA | TUR | SWE | NOR | ITA | ISR | GRC | ESP | DNK | DEU | CZE | CHE | CAN | AUT | 2 |
| NCT06101134 | Phase II | BMS-986298 Nivolumab + Relatlimab + rHuPH20 Nivolumab and relatlimab-rmbw Nivolumab | A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations | Active, not recruiting | USA | ITA | GRC | ESP | 1 |
| NCT03241745 | Phase II | Nivolumab | A Study of Nivolumab in Selected Uterine Cancer Patients | Completed | USA | 0 |
| NCT02919683 | Phase II | Nivolumab Ipilimumab + Nivolumab | Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity | Active, not recruiting | USA | 0 |
| NCT03203473 | Phase II | Nivolumab Ipilimumab + Nivolumab | Study of Optimized Management of Nivolumab Based on Response in Patients With Advanced RCC (OMNIVORE Study) | Active, not recruiting | USA | 0 |
| NCT03704077 | Phase II | Nivolumab Paclitaxel + Ramucirumab Nivolumab + Paclitaxel Nivolumab + Paclitaxel + Relatlimab Nivolumab + Relatlimab | An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Trherapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cance or Gastroesophageal Junction Adenocarcinoma | Withdrawn | USA | ROU | ITA | ESP | DEU | CAN | BRA | AUS | ARG | 5 |
| NCT02259621 | Phase II | Nivolumab | Neoadjuvant Anti-PD-1, Nivolumab in Resectable NSCLC | Active, not recruiting | USA | CAN | 0 |
| NCT03690986 | Phase I | Ipilimumab Nivolumab Ipilimumab + Pepinemab Nivolumab + Pepinemab Pepinemab | VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer | Recruiting | USA | 0 |
| NCT04606316 | Phase I | Nivolumab Ipilimumab + Nivolumab | Surgical Nivolumab And Ipilimumab For Recurrent GBM | Active, not recruiting | USA | 0 |
| NCT02481830 | Phase III | Amrubicin Nivolumab Topotecan | Efficacy Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer | Completed | USA | ROU | POL | NOR | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CHE | BRA | BEL | AUT | AUS | 6 |
| NCT03130959 | Phase II | Ipilimumab + Nivolumab Nivolumab | An Investigational Immuno-therapy Study of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Patients With High Grade Primary CNS Malignancies (CheckMate 908) | Completed | USA | SWE | POL | NOR | NLD | ISR | GBR | FRA | ESP | DEU | CAN | BRA | AUS | 2 |
| NCT04149275 | Phase II | Nivolumab Cabozantinib + Ipilimumab + Nivolumab | Cabozantinib Plus Nivolumab and Ipilimumab Women With Recurrent Gynecologic Carcinosarcoma | Withdrawn | USA | 0 |
| NCT02529072 | Phase I | Nivolumab | Nivolumab With DC Vaccines for Recurrent Brain Tumors | Completed | USA | 0 |
| NCT06715241 | Phase II | Nivolumab and relatlimab-rmbw Nivolumab | A MULTICENTER, SEEKING SIGNAL, RANDOMISED, OPEN-LABEL PHASE II of RELATLIMAB and NIVOLUMAB VS NIVOLUMAB ALONE in LOCALLY ADVANCED CERVICAL CANCERS (COLIBRI-2) | Recruiting | FRA | 0 |
| NCT03021993 | Phase II | Nivolumab | Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer | Completed | USA | 0 |
| NCT01585194 | Phase II | Ipilimumab Nivolumab | Phase II Study of Nivolumab in Combination With Ipilimumab for Uveal Melanoma | Completed | USA | 0 |
| NCT04620200 | Phase II | Ipilimumab + Nivolumab Nivolumab | Neo-adjuvant Nivolumab or Nivolumab With Ipilimumab in Advanced Cutaneous Squamous Cell Carcinoma Prior to Surgery (MATISSE) | Unknown status | NLD | 0 |
| NCT06523621 | Phase II | Nivolumab | Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel | Recruiting | USA | 0 |
| NCT04295863 | Phase I | Nivolumab Pembrolizumab | Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers | Recruiting | USA | 0 |
| NCT02785952 | Phase III | Nivolumab Ipilimumab + Nivolumab | Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers | Active, not recruiting | USA | CAN | 0 |
| NCT03635983 | Phase III | Nivolumab Nivolumab + NKTR-214 | A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma | Completed | USA | SWE | ROU | POL | NZL | NLD | ITA | ISR | IRL | GRC | GBR | FRA | FIN | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 4 |
| NCT03712202 | Phase II | Nivolumab Brentuximab vedotin + Nivolumab Brentuximab vedotin + Dacarbazine + Doxorubicin + Vinblastine Bleomycin + Dacarbazine + Doxorubicin + Vinblastine | Brentuximab Vedotin and Nivolumab in Treating Participants With Early Stage Classic Hodgkin Lymphoma | Active, not recruiting | USA | 0 |
| NCT02829918 | Phase II | Nivolumab | Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers | Completed | USA | 0 |
| NCT03245021 | Phase I | Nivolumab + Rituximab Nivolumab | Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A (1stFLOR) | Active, not recruiting | AUS | 0 |
| NCT04758949 | Phase II | Nivolumab FL-101 + Nivolumab FL-101 | FL-101 in Surgically Resectable Non-Small Cell Lung Cancer | Withdrawn | 0 | |
| NCT02864381 | Phase II | Nivolumab Andecaliximab + Nivolumab | GS-5745 Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma | Completed | USA | POL | ITA | HUN | GBR | FRA | ESP | BEL | AUS | 0 |
| NCT02924233 | Phase Ib/II | Nivolumab + SYM004 Nivolumab | Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer | Withdrawn | 0 | |
| NCT05112549 | Phase I | Nivolumab | Intrathecal Application of PD1 Antibody in Metastatic Solid Tumors With Leptomeningeal Disease (IT-PD1/ NOA 26) (IT-PD1) | Recruiting | DEU | 0 |
| NCT03815890 | Phase II | Nivolumab Ipilimumab + Nivolumab | Pre-operative Trial for Breast Cancer With Nivolumab in Combination With Novel IO (BELLINI) | Recruiting | NLD | 0 |
| NCT02475382 | Expanded access | Nivolumab | Expanded Access Program With Nivolumab Therapy for Treatment of Advanced/Metastatic SqNSCLC or Non-SqNSCLC After One Prior Systemic Regimen (CheckMate 169) | No longer available | CAN | BRA | 0 |
| NCT02105636 | Phase III | Methotrexate Cetuximab Docetaxel Nivolumab | Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) | Completed | USA | NLD | ITA | GBR | FRA | ESP | DEU | CHE | CAN | BRA | ARG | 4 |
| NCT03222076 | Phase II | Ipilimumab + Nivolumab Nivolumab | Study Evaluating Nivolumab (Anti-PD-1 Antibody) Alone Versus Nivolumab Plus Ipilimumab (Anti-CTLA-4 Antibody) in Patients With Resectable and Potentially Resectable Hepatocellular Carcinoma (HCC) (CA209-956) | Completed | USA | 0 |
| NCT06638931 | Phase II | Nivolumab | Agnostic Therapy in Rare Solid Tumors (ANTARES) | Recruiting | BRA | 0 |
| NCT03496662 | Phase Ib/II | Nivolumab BMS-813160 + Gemcitabine + Nab-paclitaxel Gemcitabine + Nab-paclitaxel BMS-813160 + Gemcitabine + Nab-paclitaxel + Nivolumab | BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) | Completed | USA | 0 |
| NCT06029270 | Phase II | Carboplatin + Gemcitabine + Nivolumab Nivolumab Nivolumab + Relatlimab Cisplatin + Gemcitabine + Nivolumab | Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer | Recruiting | USA | CAN | 2 |
| NCT03107182 | Phase II | Dexamethasone + Diphenhydramine + Famotidine + Fluorouracil + Hydroxyurea + Paclitaxel Carboplatin + Nab-paclitaxel + Nivolumab Cisplatin Carboplatin + Nivolumab + Paclitaxel Nivolumab | Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer (OPTIMA-II) | Completed | USA | 0 |
| NCT03313804 | Phase II | Pembrolizumab Atezolizumab Nivolumab | Priming Immunotherapy in Advanced Disease With Radiation | Active, not recruiting | USA | 0 |
| NCT04401774 | Phase II | Nivolumab | Nivolumab Maintenance in Newly Diagnosed PCNSL With Persistent CSF Circulating Tumor DNA After Completion of First-Line Chemotherapy | Active, not recruiting | USA | 0 |
| NCT04173325 | Phase I | Nivolumab Irinotecan + Nivolumab | Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer | Terminated | USA | 0 |
| NCT03016871 | Phase II | Nivolumab Carboplatin + Etoposide + Ifosfamide + Nivolumab | Nivolumab, Ifosfamide, Carboplatin, and Etoposide as Second-Line Therapy in Treating Patients With Refractory or Relapsed HL | Active, not recruiting | USA | 0 |
| NCT04620603 | Phase Ib/II | Nivolumab | Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer | Active, not recruiting | USA | 0 |
| NCT02466568 | Phase Ib/II | Nivolumab | Study of Nivolumab in Combination With GM.CD40L Vaccine in Adenocarcinoma of the Lung | Withdrawn | 0 | |
| NCT02066636 | Phase III | Nivolumab | A Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen (CheckMate 153) | Completed | USA | CAN | 0 |
| NCT02275533 | Phase II | Nivolumab | Nivolumab in Eliminating Minimal Residual Disease and Preventing Relapse in Patients With Acute Myeloid Leukemia in Remission After Chemotherapy | Active, not recruiting | USA | CAN | 0 |
| NCT04042753 | Phase II | Ipilimumab + Nivolumab Nivolumab | Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors | Active, not recruiting | USA | 0 |
| NCT02596035 | FDA approved | Nivolumab | A Phase 3b/4 Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374) | Completed | USA | 0 |
| NCT04268888 | Phase II | Nivolumab | Nivolumab in Combination With TACE/TAE for Patients With Intermediate Stage HCC (TACE-3) | Recruiting | GBR | 0 |
| NCT04007588 | Phase II | Ipilimumab + Nivolumab Nivolumab Linrodostat + Nivolumab | A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma | Withdrawn | USA | 0 |
| NCT03920631 | Phase I | Nivolumab | Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas (MicroBLITZ) | Withdrawn | USA | 0 |
| NCT03854032 | Phase II | Nivolumab Linrodostat + Nivolumab | Nivolumab and BMS986205 in Treating Patients With Stage II-IV Squamous Cell Cancer of the Head and Neck | Terminated | USA | 0 |
| NCT04695977 | Phase II | Nivolumab Nivolumab + Vidutolimod | CMP-001 in Combination With Nivolumab Compared to Nivolumab Monotherapy in Subjects With Advanced Melanoma | Terminated | USA | 0 |
| NCT03307616 | Phase II | Ipilimumab + Nivolumab Nivolumab | Study of Neoadjuvant Checkpoint Blockade in Patients With Surgically Resectable Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma | Active, not recruiting | USA | 0 |
| NCT03259867 | Phase II | Nivolumab Pembrolizumab | Combination of TATE and PD-1 Inhibitor in Liver Cancer | Recruiting | USA | 0 |
| NCT05496192 | Phase II | Nivolumab BMS-986298 | A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer | Withdrawn | ESP | DEU | 0 |
| NCT02439450 | Phase I | HS-110 Nivolumab | A Study of Combination Therapies With Viagenpumatucel-L (HS-110) in Patients With Non-Small Cell Lung Cancer | Completed | USA | 0 |
| NCT03110978 | Phase II | Nivolumab | Clinical Trials Comparing Immunotherapy Plus Stereotactic Ablative Radiotherapy (I-SABR) Versus SABR Alone for Stage I or Isolated Lung Parenchymal Recurrent Non-small Cell Lung Cancer: I-SABR | Active, not recruiting | USA | 0 |
| NCT02498600 | Phase II | Ipilimumab Nivolumab | Nivolumab With or Without Ipilimumab in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Active, not recruiting | USA | 0 |
| NCT02210117 | Phase II | Nivolumab Bevacizumab + Nivolumab Ipilimumab + Nivolumab | Nivolumab vs Nivolumab + Bevacizumab vs Nivolumab + Ipilimumab in Metastatic Renal Cell Carcinoma (mRCC) | Active, not recruiting | USA | 0 |
| NCT05652673 | FDA approved | Nivolumab | Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial | Recruiting | NLD | 0 |
| NCT04594811 | Phase II | Nivolumab Nivolumab + NT-I7 | NT-I7 in Combination With Nivolumab in Advanced Gastric, Gastro-Esophageal Junction or Esophageal Adenocarcinoma | Terminated | USA | POL | 0 |
| NCT05150236 | Phase II | Ipilimumab + lutetium Lu 177 vipivotide tetraxetan + Nivolumab lutetium Lu 177 vipivotide tetraxetan Nivolumab | 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPC (EVOLUTION) (EVOLUTION) | Active, not recruiting | AUS | 0 |
| NCT03055013 | Phase III | Nivolumab | Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy (PROSPER) | Active, not recruiting | USA | ISR | CAN | 0 |
| NCT03980041 | Phase II | Nivolumab Eganelisib + Nivolumab | Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) | Completed | USA | POL | ITA | FRA | ESP | CZE | 1 |
| NCT01621490 | Phase I | Ipilimumab Nivolumab | PH 1 Biomarker Study of Nivolumab and Ipilimumab and Nivolumab in Combination With Ipilimumab in Advanced Melanoma (PD-1) | Completed | USA | NLD | ESP | 0 |
| NCT03038672 | Phase II | Nivolumab + Varlilumab Nivolumab | Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas | Active, not recruiting | USA | 0 |
| NCT02631746 | Phase II | Nivolumab | Nivolumab in Treating Patients With HTLV-Associated T-Cell Leukemia/Lymphoma | Completed | USA | 0 |
| NCT02992964 | Phase Ib/II | Nivolumab | Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers | Terminated | USA | ISR | FRA | CAN | AUS | 0 |
| NCT03557359 | Phase II | Nivolumab | Nivolumab for Recurrent or Progressive IDH Mutant Gliomas | Active, not recruiting | USA | 0 |
| NCT04658147 | Phase I | Nivolumab + Relatlimab Nivolumab | Feasibility and Efficacy of Perioperative Nivolumab With or Without Neoadjuvant Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC) | Recruiting | USA | 0 |
| NCT03539198 | Phase 0 | Nivolumab | Study of Proton SBRT and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer | Terminated | USA | 0 |
| NCT02614456 | Phase I | Nivolumab Interferon gamma | Combination of Interferon-gamma and Nivolumab for Advanced Solid Tumors | Completed | USA | 0 |
| NCT04929041 | Phase II | Pembrolizumab Nab-paclitaxel Ipilimumab Paclitaxel Nivolumab Pemetrexed Disodium Carboplatin | Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative | Recruiting | USA | 0 |
| NCT02142218 | Phase I | Nivolumab | Expanded Access Program With Nivolumab to Treat Melanoma | No longer available | USA | CAN | BRA | ARG | 2 |
| NCT03508570 | Phase I | Nivolumab Ipilimumab + Nivolumab | Nivolumab With or Without Ipilimumab in Treating Participants With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis | Completed | USA | 0 |
| NCT03637543 | Phase II | Nivolumab | Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer | Active, not recruiting | USA | 0 |
| NCT02181738 | Phase II | Nivolumab | Study of Nivolumab in Subjects With Hodgkin's Lymphoma (Registrational) (CheckMate 205) | Completed | USA | NLD | ITA | GBR | ESP | DEU | CZE | CAN | BEL | AUT | 0 |
| NCT06064097 | Phase II | Nivolumab Cisplatin + Nivolumab Cisplatin + Gemcitabine + Nivolumab | A Study Using a New Drug, Nivolumab, in Combination With Chemotherapy Drugs to Treat a Type of Cancer Called Nasopharyngeal Carcinoma (NPC) | Recruiting | USA | 0 |
| NCT03383302 | Phase Ib/II | Nivolumab | SBRT With Immunotherapy in Early Stage Non-small Cell Lung Cancer: Tolerability and Lung Effects (STILE) | Active, not recruiting | GBR | 0 |
| NCT01658878 | Phase I | Nivolumab | Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab in Subjects With Advanced Liver Cancer Anti-PD-1 HCC (Anti-Programmed-Death-1 Hepatocellular Carcinoma) | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | 6 |
| NCT03811015 | Phase II | Cisplatin Nivolumab Cisplatin + Nivolumab | Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer | Suspended | USA | 0 |
| NCT03715946 | Phase II | Nivolumab | Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer | Completed | USA | 0 |
| NCT03158129 | Phase II | Nivolumab Ipilimumab + Nivolumab | Study Of Induction Checkpoint Blockade For Untreated Stage I-IIIA Non-Small Cell Lung Cancers Amenable For Surgical Resection | Active, not recruiting | USA | 0 |
| NCT03117309 | Phase II | Ipilimumab + Nivolumab Nivolumab | Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma | Unknown status | USA | 0 |
| NCT06019130 | Phase II | Cisplatin + Fluorouracil Cisplatin + Gemcitabine Nivolumab | Nivolumab in Children and Adults With Nasopharyngeal Carcinoma (NPC-Nivo) | Recruiting | DEU | 0 |
| NCT06112314 | Phase III | Nivolumab IMC-F106C + Nivolumab Nivolumab + Relatlimab | IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301) (PRISM-MEL-301) | Recruiting | USA | TUR | SWE | ROU | POL | ITA | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | BRA | BGR | AUT | AUS | ARG | 0 |
| NCT02837029 | Phase I | Nivolumab | Nivolumab and Yttrium Y 90 Glass Microspheres in Treating Patients With Advanced Liver Cancer | Completed | USA | 0 |
| NCT02823574 | Phase II | Nivolumab Ipilimumab + Nivolumab | Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | Completed | USA | TUR | SWE | ROU | NOR | NLD | ITA | IRL | GBR | FRA | FIN | ESP | CZE | CAN | BRA | BEL | ARG | 4 |
| NCT03663166 | Phase Ib/II | Cisplatin + Ipilimumab + Pemetrexed Disodium Nivolumab Carboplatin + Ipilimumab + Paclitaxel Cisplatin + Etoposide + Ipilimumab | Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC) | Terminated | USA | 0 |
| NCT03337919 | Phase II | Nivolumab | ANIMATE: Phase II Study of Nivolumab Monotherapy for Relapsed/Refractory Hodgkin Lymphoma (ANIMATE) | Active, not recruiting | GBR | 0 |
| NCT04157985 | Phase III | Nivolumab Ipilimumab Pembrolizumab Atezolizumab | Evaluation of the Length of Treatment With PD-1/PD-L1 Inhibitors in Patients With Advanced Solid Tumors | Recruiting | USA | 0 |
| NCT03803553 | Phase III | Binimetinib + Cetuximab + Encorafenib Nivolumab Fluorouracil + Irinotecan + Leucovorin | Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer | Recruiting | USA | 0 |
| NCT02832167 | Phase II | Nivolumab | An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread (CheckMate 627) | Completed | USA | DEU | 0 |
| NCT03468985 | Phase II | Cabozantinib + Nivolumab Cabozantinib + Ipilimumab + Nivolumab Nivolumab | Nivolumab, Cabozantinib S-Malate, and Ipilimumab in Treating Patients With Recurrent Stage IV Non-small Cell Lung Cancer | Completed | USA | 0 |
| NCT04080804 | Phase II | Nivolumab Nivolumab + Relatlimab Ipilimumab + Nivolumab | Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer | Recruiting | USA | 0 |
| NCT03521570 | Phase II | Nivolumab | Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer | Completed | USA | 0 |
| NCT05504252 | Phase II | Fluorouracil + Leucovorin + Oxaliplatin Nivolumab | METIMMOX-2: Metastatic pMMR/MSS Colorectal Cancer - Shaping Anti-Tumor Immunity by Oxaliplatin (METIMMOX-2) | Recruiting | NOR | 0 |
| NCT04637594 | Phase III | Durvalumab Nivolumab Atezolizumab Avelumab Pembrolizumab | Trying to Find the Correct Length of Treatment With Immune Checkpoint Therapy | Active, not recruiting | USA | 0 |
| NCT05297565 | Phase III | Nivolumab BMS-986298 | A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection (CheckMate-6GE) | Completed | USA | POL | ITA | GBR | ESP | BEL | AUS | 0 |
| NCT01454102 | Phase I | Bevacizumab Ipilimumab Cisplatin Pemetrexed Disodium Gemcitabine Erlotinib Carboplatin Paclitaxel Nivolumab | Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012) | Completed | USA | CAN | 0 |
| NCT03311958 | Phase I | Nivolumab | Molecular Monitoring With Circulating Tumor DNA and Nivolumab Maintenance | Active, not recruiting | USA | 0 |
| NCT03195491 | Phase III | Nivolumab | A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia (CheckMate870) | Completed | 2 | |
| NCT03122522 | Phase II | Nivolumab Ipilimumab + Nivolumab | A Study to Evaluate Adaptive Dosing of Ipilimumab and Nivolumab Combination Immunotherapy | Active, not recruiting | USA | 0 |
| NCT05188118 | Phase I | Cabozantinib Nivolumab Everolimus Ipilimumab Lenvatinib | Rapid Sequencing of Approved Therapies in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma | Recruiting | USA | 0 |
| NCT02880020 | Phase II | Nivolumab Ipilimumab + Nivolumab | Nivolumab With or Without Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumor That Is Metastatic or Cannot Be Removed by Surgery | Completed | USA | 0 |
| NCT03572478 | Phase Ib/II | Nivolumab + Rucaparib Nivolumab Rucaparib | Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer | Terminated | USA | 0 |
| NCT03631641 | Phase II | Nivolumab | Nivolumab in Preventing Colon Adenomas in Participants With Lynch Syndrome and a History of Partial Colectomy | Terminated | USA | 0 |
| NCT04205552 | Phase II | Nivolumab + Relatlimab Nivolumab | Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients (NEOpredict) | Recruiting | NLD | DEU | BEL | 0 |
| NCT04495010 | Phase II | Nivolumab Ipilimumab + Nivolumab | Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab+Ipilimumab Followed by Adjuvant Observation Compared With Adjuvant Nivolumab in Treatment-Naive High-risk Melanoma Participants (CheckMate 7UA) | Withdrawn | USA | SWE | POL | NLD | ITA | GBR | FRA | ESP | DNK | DEU | CHE | BRA | BEL | AUT | AUS | 1 |
| NCT02599649 | Phase II | Nivolumab Azacitidine Lirilumab | Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS) | Terminated | USA | 0 |
| NCT04810078 | Phase III | Nivolumab Nivolumab + rHuPH20 | A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (CheckMate-67T) | Recruiting | USA | TUR | ROU | POL | NZL | ITA | IRL | FRA | FIN | ESP | CZE | BRA | ARG | 4 |
| NCT03529890 | Phase II | Nivolumab | Radio-Immunotherapy Before Cystectomy in Locally Advanced Urothelial Carcinoma of the Bladder (RACE IT) | Unknown status | DEU | 0 |
| NCT02311920 | Phase I | Temozolomide Nivolumab Ipilimumab | Temozolomide in Combination With Ipilimumab and/or Nivolumab in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma | Completed | USA | 0 |
| NCT02500797 | Phase II | Ipilimumab Nivolumab | Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic or Unresectable Sarcoma | Completed | USA | 0 |
| NCT02041533 | Phase III | Nivolumab Paclitaxel Cisplatin Pemetrexed Disodium Carboplatin Gemcitabine | An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026) | Completed | USA | TUR | SWE | ROU | POL | NLD | ITA | HUN | GRC | GBR | FRA | FIN | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 4 |
| NCT02388906 | Phase III | Nivolumab Ipilimumab | Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238) | Completed | USA | SWE | ROU | POL | NOR | NLD | ITA | IRL | HUN | GRC | GBR | FRA | FIN | ESP | CZE | CHE | CAN | BEL | AUT | AUS | ARG | 4 |
| NCT02257528 | Phase II | Nivolumab | Nivolumab in Treating Patients With Persistent, Recurrent, or Metastatic Cervical Cancer | Active, not recruiting | USA | 0 |
| NCT04953104 | Phase II | Nivolumab | Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression | Recruiting | USA | 0 |
| NCT02985554 | Phase I | Nivolumab | Phase I Study to Assess the Tolerability and Efficacy of Nivolumab in Patients With Hematologic Malignancies | Terminated | USA | 0 |
| NCT03203304 | Phase I | Nivolumab Ipilimumab + Nivolumab | Study of Stereotactic Body Radiotherapy (SBRT) Followed by Nivolumab or Ipilimumab With Nivolumab in Unresectable Hepatocellular Carcinoma | Terminated | USA | 0 |
| NCT02967133 | Phase II | Nab-paclitaxel + Nivolumab Nivolumab | A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer | Terminated | USA | 0 |
| NCT04090710 | Phase II | Nivolumab Ipilimumab + Nivolumab | SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer (CYTOSHRINK) | Active, not recruiting | CAN | AUS | 0 |
| NCT03173950 | Phase II | Nivolumab | Immune Checkpoint Inhibitor Nivolumab in People With Select Rare CNS Cancers | Active, not recruiting | USA | 0 |
| NCT03470922 | Phase II | Nivolumab + Relatlimab Nivolumab | A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma | Active, not recruiting | USA | SWE | ROU | POL | NZL | NOR | ITA | ISR | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 4 |
| NCT04567615 | Phase II | Nivolumab Nivolumab + Relatlimab | A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors | Active, not recruiting | TUR | ROU | POL | NZL | FRA | ESP | CZE | BRA | ARG | 8 |
| NCT04123379 | Phase II | BMS-813160 + Nivolumab Nivolumab BMS-986253 + Nivolumab | Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC) | Active, not recruiting | USA | 0 |
| NCT03850067 | Phase Ib/II | Carboplatin + CC-90011 + Etoposide CC-90011 + Cisplatin + Etoposide Nivolumab | A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer | Completed | ITA | FRA | ESP | 0 |
| NCT03121417 | Phase II | Nivolumab | Biomarker-Driven Phase 2 Study of Nivolumab in Advanced Metastatic Non-small Cell Lung Cancer | Withdrawn | USA | 0 |
| NCT03576612 | Phase I | AdV-tk Temozolomide Valacyclovir Nivolumab | GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas (GMCI) | Active, not recruiting | USA | 0 |
| NCT02526017 | Phase I | Cabiralizumab Nivolumab | Study of FPA008 in Combination With Nivolumab in Patients With Selected Advance Cancers | Completed | USA | 0 |
| NCT03056599 | Phase I | Pembrolizumab Avelumab Interferon gamma Olaratumab Trabectedin Nivolumab Gemcitabine Interferon alpha-2b Doxorubicin Atezolizumab Eribulin Ipilimumab Durvalumab Aldesleukin Bortezomib Docetaxel | Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO™ Device in Soft Tissue Sarcoma | Completed | USA | 0 |
| NCT03591731 | Phase II | Nivolumab Ipilimumab + Nivolumab | Nivolumab +/- Ipilimumab in Patients With Advanced, Refractory Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Tumors (NECs) (NIPINEC) | Active, not recruiting | FRA | 0 |
| NCT03899155 | FDA approved | Nivolumab | Pan Tumor Nivolumab Rollover Study | Recruiting | USA | TUR | SWE | ROU | POL | NZL | NOR | NLD | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 11 |
| NCT02595944 | Phase III | Nivolumab | Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer (An ALCHEMIST Treatment Trial) (ANVIL) | Active, not recruiting | USA | 0 |
| NCT02530463 | Phase II | Nivolumab Azacitidine Ipilimumab | Nivolumab and Ipilimumab With 5-azacitidine in Patients With Myelodysplastic Syndromes (MDS) | Active, not recruiting | USA | 0 |
| NCT03768531 | Phase II | Cabiralizumab + Nivolumab Nivolumab | Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer | Withdrawn | 0 | |
| NCT02595918 | Phase I | Nivolumab | Nivolumab in Treating Patients With HIgh-Risk Non-Metastatic Kidney Cancer | Terminated | USA | 0 |
| NCT04801966 | Phase 0 | Palbociclib Alpelisib Atezolizumab Vemurafenib Ribociclib Talazoparib Cobimetinib Trametinib Abemaciclib Dabrafenib Nivolumab Binimetinib Pembrolizumab Encorafenib | Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study (TAILOR) | Terminated | AUS | 0 |
| NCT06059547 | Phase II | Nivolumab CTL-002 + Nivolumab | Neoadjuvant Immunotherapy in Combination With the Anti-GDF-15 Antibody Visugromab (CTL-002) for Treatment of Muscle Invasive Bladder Cancer | Recruiting | ITA | 0 |
| NCT02574078 | Phase Ib/II | Crizotinib + Nivolumab Erlotinib + Nivolumab Nivolumab + Pemetrexed Disodium Bevacizumab Carboplatin + Pemetrexed Disodium Bevacizumab + Nivolumab Nivolumab Erlotinib Carboplatin + Paclitaxel Carboplatin + Docetaxel Carboplatin + Nab-paclitaxel Carboplatin + Gemcitabine Paclitaxel Docetaxel Pemetrexed Disodium Gemcitabine | A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC) (CheckMate370) | Completed | USA | 0 |
| NCT04134325 | Phase I | Nivolumab Pembrolizumab | Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma | Active, not recruiting | USA | 0 |
| NCT02743494 | Phase III | Nivolumab | Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577) | Active, not recruiting | USA | TUR | ROU | POL | NLD | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUS | ARG | 10 |
| NCT03743662 | Phase II | Nivolumab Bevacizumab | Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma | Active, not recruiting | USA | 0 |
| NCT02617589 | Phase III | Nivolumab Temozolomide | Study of Nivolumab Versus Temozolomide, Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer) (CheckMate 498) | Completed | USA | SWE | POL | NOR | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BEL | AUT | AUS | 2 |
| NCT03906526 | Phase I | Motolimod Motolimod + Nivolumab Nivolumab | A Study to Evaluate Immune Biomarker Modulation in Response to VTX-2337 in Combination With an Anti- PD-1 Inhibitor in Head and Neck Cancer | Terminated | USA | 0 |
| NCT04674683 | Phase III | Nivolumab Chidamide + Nivolumab | Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma | Active, not recruiting | USA | NZL | ITA | GBR | FRA | ESP | DEU | CZE | BRA | BEL | AUT | AUS | 5 |
| NCT03437200 | Phase II | Nivolumab Ipilimumab + Nivolumab | Combination of Chemoradiation With Immunotherapy in Inoperable œsophageal Cancer (CRUCIAL) | Terminated | FRA | ESP | 0 |
| NCT03317327 | Phase Ib/II | Nivolumab | REirradiation and Programmed Cell Death Protein 1 (PD-1) Blockade On Recurrent Squamous Cell Head and Neck Tumors (REPORT) | Recruiting | NOR | 0 |
| NCT03126331 | Phase II | Nivolumab | Intermittent Nivolumab in Metastatic Renal Cell Carcinoma Patients | Completed | USA | 0 |
| NCT04957615 | Phase II | Nivolumab | Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and CXCL13 Expression | Recruiting | USA | 0 |
| NCT03215810 | Phase I | Nivolumab tumor infiltrating lymphocytes Cyclophosphamide + Fludarabine Aldesleukin | Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer | Completed | USA | 0 |
| NCT03025256 | Phase I | Nivolumab | Study of Concurrent Intravenous and Intrathecal Nivolumab for Patients With Leptomeningeal Disease (LMD) | Recruiting | USA | 0 |
| NCT02477826 | Phase III | Nivolumab Cisplatin Ipilimumab Pemetrexed Disodium Carboplatin Gemcitabine | An Open-Label, Trial of Nivolumab and Nivolumab Plus Ipilimumab Versus Platinum Doublet Chemotherapy in Subjects With Stage IV Non-Small Cell Lung Cancer (NSCLC) | Completed | USA | ROU | POL | NLD | LBN | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 10 |
| NCT01928576 | Phase II | Nivolumab Entinostat Azacitidine | Phase II Anti-PD1 Epigenetic Priming Study in NSCLC. | Completed | USA | 0 |
| NCT04462406 | Phase II | Pembrolizumab Nivolumab + Pembrolizumab Ipilimumab + Nivolumab Ipilimumab + Pembrolizumab Nivolumab | Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial | Recruiting | USA | 0 |
| NCT03703050 | Phase II | Nivolumab | Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2) (NIVO-ALCL) | Active, not recruiting | GBR | FRA | DNK | 0 |
| NCT04361058 | Phase I | Nivolumab | Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide | Withdrawn | USA | 0 |
| NCT05846659 | Phase II | Nivolumab IMSA101 + Nivolumab IMSA101 + Pembrolizumab Pembrolizumab | Study of PULSAR-ICI +/- IMSA101 in Patients With Oligoprogressive Solid Tumor Malignancies | Terminated | USA | 0 |
| NCT02421354 | Phase II | Nivolumab | Study of Nivolumab in Patients With Myelofibrosis | Terminated | USA | 0 |
| NCT03980314 | Phase Ib/II | Nivolumab | A Study to Compare Nivolumab Drug Product Process D to Nivolumab Drug Product Process C in Participants With Stage IIIa/b/c/d or Stage IV Melanoma After Complete Resection | Completed | USA | ROU | POL | NZL | ITA | IRL | FRA | ESP | CAN | BRA | AUS | ARG | 2 |
| NCT06054555 | Phase III | ABP 206 Nivolumab | A Study to Evaluate ABP 206 Compared With OPDIVO (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma | Recruiting | USA | TUR | ROU | NLD | LTU | ITA | HUN | HRV | FRA | EST | ESP | DEU | CZE | CAN | ARG | 14 |
| NCT03580408 | Phase II | Nivolumab + Vinblastine Nivolumab | Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients With Classical Hodgkin Lymphoma | Completed | FRA | BEL | 0 |
| NCT06745076 | Phase II | Nivolumab Dacarbazine + Doxorubicin + Nivolumab + Vinblastine | Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma | Not yet recruiting | USA | 0 |
| NCT02387996 | Phase II | Nivolumab | A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer | Completed | USA | SWE | POL | ITA | FIN | ESP | DEU | CZE | BEL | AUS | 1 |
| NCT02864316 | Phase II | Nivolumab | Phase 2 Study of Nivolumab in Solid Tumors Induced by Prior Radiation Exposure | Terminated | USA | 0 |
| NCT03656627 | Phase I | Nivolumab | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Terminated | USA | 0 |
| NCT06275360 | Phase II | Nivolumab Carboplatin + Nivolumab + Pemetrexed Disodium Carboplatin + Nivolumab + Paclitaxel | Repositioning Immunotherapy in VetArans With Lung Cancer (RIVAL) | Recruiting | USA | 0 |
| NCT04410445 | Phase III | Nivolumab Nivolumab + NKTR-214 | Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12) | Terminated | USA | ROU | POL | NZL | NLD | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CZE | AUT | AUS | 2 |
| NCT03238365 | Phase I | Nivolumab + Tadalafil Nivolumab | Nivolumab With or Without Tadalafil in Treating Patients With Recurrent Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery | Completed | USA | 0 |
| NCT04591431 | Phase II | Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) | Active, not recruiting | ITA | 0 |
| NCT03080974 | Phase II | Nivolumab | Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma | Recruiting | USA | 0 |
| NCT02038946 | Phase II | Nivolumab | Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140) | Completed | USA | SWE | NOR | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 1 |
| NCT03918252 | Phase II | Ipilimumab + Nivolumab Nivolumab | Neoadjuvant Immune Checkpoint Blockade in Resectable Malignant Pleural Mesothelioma | Active, not recruiting | USA | 0 |
| NCT03519256 | Phase II | Linrodostat + Nivolumab Nivolumab BCG solution + Nivolumab BCG solution + Linrodostat + Nivolumab | A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder (CheckMate 9UT) | Terminated | USA | NLD | ITA | GBR | FRA | ESP | CAN | BRA | AUS | ARG | 5 |
| NCT03075553 | Phase II | Nivolumab | Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma | Terminated | USA | 0 |
| NCT01176474 | Phase I | NY-ESO-1 peptide vaccine Ipilimumab Nivolumab | A Phase I Trial of a Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma | Completed | USA | 0 |
| NCT04697576 | Phase I | Nivolumab Pembrolizumab Ipilimumab | Intralesional Influenza Vaccine for the Treatment of Stage I, II, and IV Melanoma | Recruiting | USA | 0 |
| NCT04114136 | Phase II | Nivolumab Metformin + Nivolumab Pembrolizumab Metformin + Pembrolizumab Pembrolizumab + Rosiglitazone Nivolumab + Rosiglitazone | Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies | Recruiting | USA | 0 |
| NCT02764593 | Phase I | Nivolumab Cisplatin + Nivolumab Cetuximab + Nivolumab | Chemotherapy +/- Nivolumab in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma | Completed | USA | 0 |
| NCT03532451 | Phase I | Lirilumab + Nivolumab Nivolumab | Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer (PrE0807) | Completed | USA | 0 |
| NCT03355560 | Phase II | Nivolumab | Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy | Active, not recruiting | USA | 0 |
| NCT02469701 | Phase II | Nivolumab | BrUOG 317: Nivolumab and Ablation For Patients With Advanced Non-Small Cell Lung Cancer Progressing After at Least One Prior Therapy For Metastatic Disease | Terminated | USA | 0 |
| NCT02194738 | Phase I | Nivolumab Crizotinib Erlotinib | Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial) | Recruiting | USA | 2 |
| NCT04526730 | Phase II | Nivolumab + Tavokinogene telseplasmid Nivolumab | Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients | Active, not recruiting | USA | 0 |
| NCT03134118 | Phase II | Nivolumab | Nivolumab in Patients With Type B3 Thymoma and Thymic Carcinoma (NIVOTHYM) (NIVOTHYM) | Active, not recruiting | NLD | GBR | FRA | ESP | CHE | BEL | 0 |
| NCT02829931 | Phase I | Nivolumab | Hypofractionated Stereotactic Irradiation With Nivolumab in Patients With Recurrent High Grade Gliomas | Completed | USA | 0 |
| NCT02684253 | Phase II | Nivolumab | Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) | Completed | USA | 0 |
| NCT06295159 | Phase I | Nivolumab Nivolumab and relatlimab-rmbw Ipilimumab + Nivolumab | Biomarker Driven Patient Selection Neoadjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma | Recruiting | USA | 0 |
| NCT02565758 | Phase I | Gemcitabine Nivolumab Nab-paclitaxel ABBV-085 | ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Cancer Tumors | Completed | USA | FRA | ESP | 0 |
| NCT03873402 | Phase III | Nivolumab Ipilimumab + Nivolumab | An Immunotherapy Study of Nivolumab Plus Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer | Active, not recruiting | USA | ROU | POL | ITA | GRC | FRA | ESP | CZE | AUT | ARG | 4 |
| NCT02648997 | Phase II | Nivolumab | A Study of Nivolumab in Adult Participants With Recurrent High-Grade Meningioma | Active, not recruiting | USA | 0 |
| NCT04050462 | Phase II | BMS-986253 + Nivolumab Nivolumab Cabiralizumab + Nivolumab | A Phase II, Randomized, Controlled Trial of Nivolumab in Combination With BMS-986253 or Cabiralizumab in Advanced Hepatocellular Carcinoma (HCC) Patients | Active, not recruiting | USA | 0 |
| NCT02989636 | Phase I | Nivolumab | Nivolumab With or Without Stereotactic Radiosurgery in Treating Patients With Recurrent, Advanced, or Metastatic Chordoma | Active, not recruiting | USA | 0 |
| NCT06534983 | Phase II | Nivolumab Autogene cevumeran + Nivolumab | A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) (IMCODE004) | Recruiting | USA | SWE | POL | NOR | ITA | GRC | GBR | ESP | DNK | DEU | CAN | BEL | AUS | ARG | 2 |
| NCT04875611 | Phase II | Nivolumab | Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment (NIVONASO-21) | Not yet recruiting | POL | 0 |
| NCT03604978 | Phase Ib/II | Ipilimumab + Nivolumab Nivolumab | Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Participants With Recurrent Grade II-III Meningioma | Recruiting | USA | 0 |
| NCT05907122 | Phase III | Nivolumab | A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO (Nivolumab) in Subjects With Resected Melanoma | Active, not recruiting | USA | ROU | NLD | ITA | HRV | FRA | ESP | DEU | BRA | ARG | 13 |
| NCT02314169 | Phase II | Nivolumab | Nivolumab in Treating Patients With Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal | Active, not recruiting | USA | CAN | 0 |
| NCT05681780 | Phase Ib/II | Cyclophosphamide + Fludarabine Aldesleukin Nivolumab CD40L-augmented TILs | Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC | Recruiting | USA | 0 |
| NCT02897765 | Phase I | Nivolumab NEO-PV-01 + Poly ICLC | A Personalized Cancer Vaccine (NEO-PV-01) w/ Nivolumab for Patients With Melanoma, Lung Cancer or Bladder Cancer | Completed | USA | 0 |
| NCT03878524 | Phase I | Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab | A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) | Terminated | USA | 0 |
| NCT02652455 | Phase I | Nivolumab Aldesleukin + Cyclophosphamide + Fludarabine Urelumab | Combining PD-1 Blockade, CD137 Agonism and Adoptive Cell Therapy for Metastatic Melanoma | Completed | USA | 0 |
| NCT02846376 | Phase I | Ipilimumab Ipilimumab + Nivolumab Nivolumab | Single Agent and Combined Inhibition After Allogeneic Stem Cell Transplant (CPIT-002) | Terminated | USA | 0 |
| NCT02696993 | Phase Ib/II | Nivolumab Ipilimumab + Nivolumab | Nivolumab and Radiation Therapy With or Without Ipilimumab in Treating Patients With Brain Metastases From Non-small Cell Lung Cancer | Active, not recruiting | USA | 0 |
| NCT04648319 | Phase II | Nivolumab | A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma | Terminated | LUX | LBN | BEL | 0 |
| NCT03521830 | Phase II | Nivolumab Ipilimumab + Nivolumab | Nivolumab Alone or Plus Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma | Recruiting | USA | 0 |
| NCT02720484 | Phase II | Nivolumab | Nivolumab in Treating Patients With Metastatic Adrenocortical Cancer | Terminated | USA | 0 |
| NCT03495713 | Phase II | Nivolumab | RADVAX FOR RELAPSED/REFRACTORY HODGKIN LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS | Terminated | USA | 0 |
| NCT03527108 | Phase II | Nivolumab + Ramucirumab Nivolumab | Nivolumab Plus Ramucirumab in Patients With Recurrent, Advanced, Metastatic NSCLC | Recruiting | USA | 0 |
| NCT03421652 | Phase II | Nivolumab | Nivolumab and Radiation Therapy in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemotherapy | Completed | USA | 0 |
| NCT02962804 | Phase II | Nivolumab | Combination Radiation and PD-1 Inhibition in Metastatic or Recurrent Renal Cell Carcinoma (RCC) | Withdrawn | USA | 0 |
| NCT04131621 | Phase II | Nivolumab Ipilimumab Ipilimumab + Nivolumab | Nivolumab/Ipilimumab in Second Line CUP-syndrome (CheCUP) | Unknown status | DEU | 0 |
| NCT04401995 | Phase II | Nivolumab Nivolumab + Vidutolimod | Study of TLR9 Agonist CMP-001 in Combination With Nivolumab vs. Nivolumab | Completed | USA | 0 |
| NCT02339558 | Phase II | Nivolumab | Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer | Completed | USA | 2 |
| NCT02599402 | Phase III | Ipilimumab + Nivolumab Nivolumab | Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma | Completed | SWE | NOR | ITA | IRL | GBR | FRA | FIN | DEU | CHE | BEL | AUT | AUS | 0 |
| NCT02569242 | Phase III | Docetaxel + Paclitaxel Nivolumab | Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer | Completed | USA | ITA | GBR | DNK | DEU | 3 |
| NCT03432741 | Phase I | Carfilzomib Daratumumab Obinutuzumab Gemcitabine Trastuzumab Romidepsin Nivolumab Rituximab Belinostat Pembrolizumab | Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer | Suspended | USA | 0 |
| NCT05111574 | Phase II | Nivolumab Cabozantinib + Nivolumab | Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery | Recruiting | USA | CAN | 0 |
| NCT03436862 | Phase II | Nivolumab | Nivolumab as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Hodgkin Lymphoma at Risk of Relapse or Progression | Completed | USA | 0 |
| NCT04042506 | Phase II | Nivolumab | SBRT as a Vaccination for Metastatic Melanoma | Withdrawn | USA | 0 |
| NCT02575222 | Phase I | Nivolumab | Study of Neoadjuvant Nivolumab in Patients With Non-metastatic Stage II-IV Clear Cell Renal Cell Carcinoma | Completed | USA | 0 |
| NCT02423343 | Phase Ib/II | Galunisertib Nivolumab | A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, Hepatocellular Carcinoma, or Glioma | Completed | USA | ESP | 0 |
| NCT03224871 | Phase I | Pembrolizumab Aldesleukin Nivolumab | A Pilot Study of Interlesional IL-2 and RT in Patients With NSCLC. | Completed | USA | 0 |
| NCT06319196 | Phase II | Nivolumab Nivolumab and relatlimab-rmbw | Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma (ClearMe) | Recruiting | CAN | 0 |
| NCT03329846 | Phase III | Linrodostat + Nivolumab Nivolumab | An Investigational Immuno-therapy Study of BMS-986205 Combined With Nivolumab, Compared to Nivolumab by Itself, in Patients With Advanced Melanoma | Completed | USA | POL | NZL | NLD | ITA | IRL | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | AUS | 1 |
| NCT05846646 | Phase II | Pembrolizumab Nivolumab IMSA101 + Nivolumab IMSA101 + Pembrolizumab | Study of PULSAR-ICI +/- IMSA101 in Patients With Oligometastatic NSCLC and RCC | Terminated | USA | 0 |
| NCT02259231 | Phase Ib/II | Ipilimumab Nivolumab Omaveloxolone | RTA 408 Capsules in Patients With Melanoma - REVEAL | Completed | USA | 0 |
| NCT02716948 | Phase I | Nivolumab | Stereotactic Radiosurgery and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or Spine | Completed | USA | 0 |
| NCT04106414 | Phase II | Nivolumab Linrodostat + Nivolumab | Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment | Active, not recruiting | USA | 0 |
| NCT05002569 | Phase III | Nivolumab + Relatlimab Nivolumab | A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma (RELATIVITY-098) | Active, not recruiting | USA | SWE | ROU | NOR | ITA | ISR | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 3 |
| NCT04500548 | Phase I | Nivolumab Ipilimumab + Nivolumab | Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study | Withdrawn | USA | CAN | 0 |
| NCT03668119 | Phase II | Ipilimumab + Nivolumab Nivolumab | A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H) (CheckMate 848) | Completed | USA | ROU | POL | NLD | ITA | GBR | FRA | ESP | DNK | DEU | CAN | BEL | AUS | ARG | 3 |
| NCT04570839 | Phase Ib/II | BMS-986207 + COM701 + Nivolumab Nivolumab | COM701 in Combination With BMS-986207 and Nivolumab in Subjects With Advanced Solid Tumors. | Completed | USA | 0 |
| NCT03325816 | Phase Ib/II | Nivolumab | Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer | Completed | USA | 0 |
| NCT03952585 | Phase II | Nivolumab Cisplatin | De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer | Active, not recruiting | USA | CAN | 0 |
| NCT03383458 | Phase III | Nivolumab | A Phase 3 Study of Nivolumab in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation | Active, not recruiting | USA | ROU | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 10 |
| NCT03595124 | Phase II | Nivolumab Axitinib + Nivolumab Axitinib | A Study to Compare Treatments for a Type of Kidney Cancer Called TFE/Translocation Renal Cell Carcinoma (tRCC) | Active, not recruiting | USA | 1 |
| NCT03543189 | Phase Ib/II | Nivolumab | Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy | Active, not recruiting | USA | 0 |
| NCT03544723 | Phase II | Nivolumab Ad5CMV-p53 gene + Nivolumab | Safety and Efficacy of Ad-p53 in Head and Neck Cancer | Unknown status | USA | 0 |
| NCT03600155 | Phase I | Nivolumab Ipilimumab Ipilimumab + Nivolumab | Nivolumab and Ipilimumab After Donor Stem Cell Transplant in Treating Participants With High Risk Refractory or Relapsed Acute Myeloid Leukemia | Completed | USA | 0 |
| NCT06237920 | Phase II | Nivolumab Nivolumab + Relatlimab | Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab (TURANDORELA) | Recruiting | NLD | 0 |
| NCT04866654 | Phase II | Nivolumab | Radiation Free Chemotherapy for Early Hodgkin Lymphoma (RAFTING) | Recruiting | POL | ITA | ESP | 0 |
| NCT02978404 | Phase II | Nivolumab | Combining Radiosurgery and Nivolumab in the Treatment of Brain Metastases | Completed | CAN | 0 |
| NCT05310591 | Phase Ib/II | Cyclophosphamide + Fludarabine Nivolumab Tisagenlecleucel | Combination of an Anti-PD1 Antibody With Tisagenlecleucel Reinfusion in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia After Loss of Persistence (CAPTiRALL) | Recruiting | FRA | 0 |
| NCT02914405 | Phase I | Dinutuximab beta + Nivolumab Nivolumab | Phase I Study of 131-I mIBG Followed by Nivolumab & Dinutuximab Beta Antibodies in Children With Relapsed/Refractory Neuroblastoma (MiniVan) | Active, not recruiting | USA | GBR | 0 |
| NCT03727061 | Phase II | Cisplatin + Fluorouracil Carboplatin + Fluorouracil Pembrolizumab Cetuximab Nivolumab | Porfimer Sodium Interstitial Photodynamic Therapy With or Without Standard of Care Chemotherapy in Treating Patients With Locally Advanced or Recurrent Head and Neck Cancer | Terminated | USA | 0 |
| NCT03425292 | Phase I | Temozolomide Ipilimumab + Nivolumab Nivolumab | A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer | Completed | USA | 0 |
| NCT03371381 | Phase Ib/II | JNJ-64041757 + Nivolumab Nivolumab | An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung | Terminated | USA | ESP | BEL | 0 |
| NCT02154490 | Phase II | Docetaxel Nivolumab Palbociclib Durvalumab Ipilimumab + Nivolumab Fexagratinib Taselisib Durvalumab + Tremelimumab Erlotinib + Rilotumumab Talazoparib Erlotinib | Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer | Completed | USA | CAN | 0 |
| NCT02488759 | Phase Ib/II | Nivolumab | A Study to Investigate the Safety and Efficacy of Nivolumab in Virus-associated Tumors (CheckMate358) | Completed | USA | NLD | GBR | FRA | ESP | DEU | BEL | 4 |
| NCT06116461 | FDA approved | Nivolumab | Nivolumab Dose Optimization in Patients With a Complete, Partial or Stable Response (NIVOPTIMIZE) | Recruiting | NLD | 0 |
| NCT04309409 | Phase III | Nivolumab | Adjuvant Nivolumab Treatment in Stage II (IIA, IIB, IIC) High-risk Melanoma (NivoMela) | Active, not recruiting | DEU | 0 |
| NCT03302247 | Phase II | Nivolumab Gemcitabine + Nivolumab | Depletion of Myeloid Derived Suppressor Cells to Enhance Anti PD-1 Therapy | Terminated | USA | 0 |
| NCT03090737 | Phase II | Nivolumab | Safety Study of Nivolumab to Treat Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 907) | Completed | USA | ROU | CAN | 2 |
| NCT02553642 | Phase II | Nivolumab Ipilimumab | Relationship Between Tumor Mutation Burden and Predicted Neo-antigen Burden in Patients With Advanced Melanoma or Bladder Cancer Treated With Nivolumab or Nivolumab Plus Ipilimumab (CA209-260) | Completed | USA | 0 |
| NCT03817125 | Phase I | Nivolumab + SER-401 Vancomycin Nivolumab | Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention (MCGRAW) | Completed | USA | 0 |
| NCT03465592 | Phase Ib/II | Nivolumab | Trial of Nivolumab Following Partially HLA Mismatched BMT in Children & Adults With Sarcoma | Recruiting | USA | 0 |
| NCT06410534 | Phase II | Nivolumab Ipilimumab + Nivolumab | A Phase II Study Evaluating an Organ Preservation Strategy Using Immune Checkpoint Blockade for Participants With Primary Colorectal or Gastroesophageal Cancer | Recruiting | USA | 0 |
| NCT03520491 | Phase II | Ipilimumab + Nivolumab Nivolumab | A Study to Test the Safety of Immunotherapy With Nivolumab Alone or With Ipilimumab Before Surgery for Bladder Cancer Patients Who Are Not Suitable for Chemotherapy | Recruiting | USA | 0 |
| NCT04400539 | Phase II | Nivolumab | The IMmunotherapy Pleural 5-ALA PDT (IMPALA) | Recruiting | FRA | 0 |
| NCT02472977 | Phase Ib/II | Nivolumab Ulocuplumab | Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors | Terminated | USA | FIN | 0 |
| NCT06264180 | Phase III | Nab-paclitaxel Nivolumab + RP1 Paclitaxel Nivolumab and relatlimab-rmbw Nivolumab Dacarbazine Pembrolizumab Temozolomide | VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs (IGNYTE-3) | Recruiting | USA | 0 |
| NCT04026412 | Phase III | Nivolumab Ipilimumab + Nivolumab Durvalumab | A Study of Nivolumab and Ipilimumab in Untreated Patients With Stage 3 NSCLC That is Unable or Not Planned to be Removed by Surgery (CheckMate73L) | Completed | USA | SWE | ROU | POL | NLD | ITA | IRL | GRC | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BEL | AUS | ARG | 9 |
| NCT02731729 | Phase II | Ipilimumab Nivolumab | Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy | Completed | USA | 0 |
| NCT03068455 | Phase III | Nivolumab Ipilimumab Ipilimumab + Nivolumab | A Study of Nivolumab in Combination With Ipilimumab Compared to Nivolumab or Ipilimumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma (CheckMate 915) | Completed | USA | ROU | POL | NZL | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | 1 |
| NCT04095208 | Phase II | Nivolumab + Relatlimab Nivolumab | Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study (CONGRATS) | Recruiting | FRA | 0 |
| NCT02060188 | Phase Ib/II | Nivolumab Ipilimumab | A Study of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Colon Cancer (CheckMate 142) | Completed | USA | ITA | IRL | FRA | ESP | CAN | BEL | AUS | 0 |
| NCT03461952 | Phase II | Nivolumab Ipilimumab + Nivolumab | Nivolumab Ipilimumab in Patients With hyperMutated Cancers Detected in Blood (NIMBLe) (NIMBLe) | Terminated | USA | CAN | 0 |
| NCT03651271 | Phase II | Ipilimumab + Nivolumab Nivolumab | Treatment With Nivolumab and Ipilimumab or Nivolumab Alone According to the Percentage of Tumoral CD8 Cells in Advanced Metastatic Cancer | Completed | USA | 0 |
| NCT04929028 | Phase II | Capecitabine + Mitomycin C Nivolumab Fluorouracil + Mitomycin C | Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer | Recruiting | USA | 0 |
| NCT03355976 | Phase II | Ipilimumab + Nivolumab Nivolumab | BrUOG 354 Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas | Active, not recruiting | USA | 0 |
| NCT02713867 | Phase III | Nivolumab | A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received 4 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks (CheckMate 384) | Completed | USA | ITA | FRA | ESP | DEU | CAN | AUT | AUS | 0 |
| NCT04209114 | Phase III | Nivolumab + NKTR-214 Nivolumab | A Study of Nivolumab Plus NKTR-214 vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That Has Invaded the Muscle Wall of the Bladder and Who Cannot Get Cisplatin, a Type of Medicine Given to Treat Bladder Cancer. | Completed | USA | POL | NLD | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 3 |
| NCT03149120 | Phase II | Nivolumab Nivolumab + Pazopanib | Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas | Withdrawn | USA | 0 |
| NCT03999749 | Phase II | Nivolumab Ipilimumab + Nivolumab + Tocilizumab | A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma | Active, not recruiting | USA | 0 |
| NCT03522246 | Phase III | Rucaparib Nivolumab Nivolumab + Rucaparib | A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA) | Active, not recruiting | USA | TUR | SWE | ROU | POL | NZL | ITA | ISR | IRL | GRC | GBR | FIN | ESP | DNK | DEU | CZE | CAN | BEL | AUS | 5 |
| NCT03878979 | Phase II | Nivolumab | Preoperative Immune Checkpoint Inhibitor for Patients With Recurrent or Metastatic SCCHN Undergoing Surgical Salvage | Completed | USA | 0 |
| NCT04205409 | Phase II | Nivolumab | Nivolumab for the Treatment of Relapsed or Refractory Hematologic Malignancies | Active, not recruiting | USA | 0 |
| NCT03143270 | Phase I | Nivolumab | A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer | Active, not recruiting | USA | 0 |
| NCT02538666 | Phase III | Ipilimumab Nivolumab | A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451) | Completed | USA | SWE | ROU | POL | NLD | ITA | ISR | IRL | GRC | GBR | FRA | FIN | ESP | DEU | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 11 |
| NCT03233711 | Phase II | Nivolumab | Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer | Active, not recruiting | USA | CAN | 0 |
| NCT02598960 | Phase Ib/II | Nivolumab BMS-986156 | A Study of BMS-986156 Given Alone and in Combination With Nivolumab in Subjects With Advanced Solid Tumors | Completed | USA | NLD | ITA | FRA | ESP | DEU | CHE | CAN | BEL | AUS | 0 |
| NCT03630640 | Phase II | Nivolumab | Neoadjuvant and Adjuvant Nivolumab in HCC Patients Treated by Electroporation (NIVOLEP) | Completed | FRA | 0 |
| NCT03106610 | Phase I | Nivolumab | Trial of Anti-PD-1 (Nivolumab) in Bladder Cancer Patients Recently Treated With Intravesical BCG Immunotherapy | Terminated | USA | 0 |
| NCT05465174 | Phase II | Nivolumab + Tovorafenib Tovorafenib Nivolumab | Nivolumab and DAY101 for Treatment of Craniopharyngioma in Children and Young Adults (PNOC029) | Recruiting | USA | 0 |
| NCT03258567 | Phase II | Nivolumab | Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas | Recruiting | USA | 0 |
| NCT03285321 | Phase II | Ipilimumab + Nivolumab Nivolumab | Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC) | Active, not recruiting | USA | 0 |
| NCT04785820 | Phase II | RO7121661 Nivolumab RO7247669 | A Study of RO7121661 and RO7247669 Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus | Active, not recruiting | TUR | POL | ITA | HUN | GBR | FRA | ESP | DNK | CZE | BRA | ARG | 7 |
| NCT03367741 | Phase II | Cabozantinib + Nivolumab Nivolumab | Cabozantinib and Nivolumab in Treating Patients With Advanced, Recurrent or Metastatic Endometrial Cancer | Active, not recruiting | USA | CAN | 0 |
| NCT03798639 | Phase I | Ipilimumab + Nivolumab Nivolumab | Nivolumab and Radiation Therapy or Ipilimumab as Adjuvant Therapy in Treating Patients With Merkel Cell Cancer | Completed | USA | 0 |
| NCT04128020 | Phase I | Azacitidine + Nivolumab Nivolumab | Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia | Withdrawn | 0 | |
| NCT03604991 | Phase II | Carboplatin + Paclitaxel Nivolumab Carboplatin + Nivolumab + Paclitaxel Ipilimumab + Nivolumab | Carboplatin, Paclitaxel and Radiation Therapy With or Without Nivolumab and Ipilimumab in Treating Participants With Esophageal and Gastroesophageal Junction Adenocarcinoma | Suspended | USA | 0 |
| NCT02737475 | Phase Ib/II | Ipilimumab BMS-986178 Nivolumab | Study of BMS-986178 Monotherapy or in Combination With Nivolumab or Ipilimumab in Subjects With Advanced Solid Tumors | Completed | USA | NLD | ITA | ISR | ESP | CAN | 0 |
| NCT04913025 | Phase II | Pembrolizumab Nivolumab | REduced Frequency ImmuNE Checkpoint Inhibition in Cancers (REFINE) | Recruiting | GBR | 0 |
| NCT04848116 | Phase II | Cabiralizumab + Nivolumab BMS-986253 + Nivolumab Nivolumab | Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca (Spark2) | Recruiting | USA | 0 |
| NCT03168464 | Phase Ib/II | Nivolumab | Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632) | Terminated | USA | 0 |
| NCT03247712 | Phase Ib/II | Nivolumab | Neoadjuvant Immunoradiotherapy in Head & Neck Cancer | Active, not recruiting | USA | 0 |
| NCT06632327 | Phase III | Docetaxel + Gemcitabine + Nivolumab Cisplatin + Nivolumab + Pemetrexed Disodium Pembrolizumab Carboplatin + Pembrolizumab + Vinorelbine Carboplatin + Nivolumab + Vinorelbine Carboplatin + Gemcitabine Atezolizumab + Carboplatin + Gemcitabine Docetaxel + Gemcitabine Nivolumab Carboplatin + Nivolumab + Pemetrexed Disodium Atezolizumab + Cisplatin + Gemcitabine Atezolizumab + Cisplatin + Pemetrexed Disodium Cisplatin + Gemcitabine + Nivolumab Atezolizumab + Cisplatin + Vinorelbine Cisplatin + Pembrolizumab + Pemetrexed Disodium Atezolizumab + Carboplatin + Vinorelbine Atezolizumab + Docetaxel + Gemcitabine Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Gemcitabine Carboplatin + Gemcitabine + Nivolumab Atezolizumab Carboplatin + Gemcitabine + Pembrolizumab Carboplatin + Vinorelbine Docetaxel + Gemcitabine + Pembrolizumab Cisplatin + Gemcitabine + Pembrolizumab Cisplatin + Vinorelbine Cisplatin + Pembrolizumab + Vinorelbine Atezolizumab + Carboplatin + Pemetrexed Disodium | Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer | Not yet recruiting | USA | 0 |
| NCT03166397 | Phase II | Cyclophosphamide + Fludarabine Aldesleukin Nivolumab tumor infiltrating lymphocytes Ipilimumab | Adoptive Cell Therapy Following a Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients | Recruiting | ISR | 0 |
| NCT04013854 | Phase II | Ipilimumab + Nivolumab Nivolumab | Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab | Active, not recruiting | USA | 0 |
| NCT03316274 | Phase I | Nivolumab | Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma | Completed | USA | 0 |
| NCT03807765 | Phase I | Nivolumab | Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases | Active, not recruiting | USA | 0 |
| NCT04949113 | Phase III | Nivolumab Ipilimumab + Nivolumab | Neoadjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab in Macroscopic Stage III Melanoma (NADINA) | Active, not recruiting | USA | NLD | AUS | 0 |
| NCT05817903 | Phase II | Nivolumab Axitinib + Nivolumab | Phase II Study of Axitinib Intensification Plus Nivolumab Compared to Nivolumab Alone After Induction With Nivolumab Plus Ipilimumab in mRCC Patients Without Previous CR (AxIn) | Recruiting | ITA | 0 |
| NCT03430791 | Phase II | Ipilimumab + Nivolumab Nivolumab | Trial of Combination TTF(Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma | Terminated | USA | 0 |
| NCT05987241 | Phase II | Nivolumab Nivolumab + Relatlimab | Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study | Recruiting | USA | 0 |
| NCT03115801 | Phase II | Atezolizumab Nivolumab | A Phase II Randomized Trial of Immunotherapy Plus Radiotherapy in Metastatic Genitourinary Cancers | Terminated | USA | 0 |
| NCT02736123 | Phase Ib/II | Nivolumab Ipilimumab + Nivolumab | Neoadjuvant Combination Biotherapy With Ipilimumab and Nivolumab or Nivolumab Alone | Withdrawn | USA | 0 |
| NCT05317000 | Phase I | Azacitidine Azacitidine + Nivolumab Nivolumab | 5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC | Recruiting | USA | 0 |
| NCT02519322 | Phase II | Ipilimumab Nivolumab | Neoadjuvant and Adjuvant Checkpoint Blockade in Patients With Clinical Stage III or Oligometastatic Stage IV Melanoma | Completed | USA | 0 |
| NCT04387084 | Phase I | Durvalumab Pembrolizumab Avelumab Cemiplimab Atezolizumab Nivolumab | Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy | Active, not recruiting | USA | 0 |
| NCT05112601 | Phase II | Ipilimumab + Nivolumab Nivolumab | Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma | Recruiting | USA | 0 |
| NCT03023904 | Phase II | Nivolumab | Nivolumab in Treating Patients With Stage IV or Recurrent Lung Cancer With High Mutation Loads | Withdrawn | 0 | |
| NCT03405155 | Phase II | Nivolumab | Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery | Active, not recruiting | USA | 0 |
| NCT01928394 | Phase Ib/II | Ipilimumab + Nivolumab Cobimetinib + Ipilimumab + Nivolumab Nivolumab | A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors | Completed | USA | ITA | GBR | FIN | ESP | DNK | DEU | CAN | 0 |
| NCT03879811 | Phase II | Nivolumab Temozolomide | Determining the Effects of Temozolomide Followed by Nivolumab in Patients With Colorectal Cancer | Withdrawn | 0 | |
| NCT03793166 | Phase III | Nivolumab Cabozantinib + Nivolumab Cabozantinib Ipilimumab + Nivolumab | Nivolumab and Ipilimumab Followed by Nivolumab Versus Cabozantinib and Nivolumab in Treating Patients With Metastatic Untreated Renal Cell Cancer | Active, not recruiting | USA | 1 |
| NCT03371992 | Phase I | Nivolumab | Pilot Study of Nilogen 3D-EX and Its Ability to Predict Therapeutic Response to Anti-PD1 or Anti-PDL1 in NSCLC (NO3DEXPL) | Unknown status | USA | 0 |
| NCT01592370 | Phase Ib/II | Nivolumab Daratumumab + Nivolumab Daratumumab Ipilimumab + Nivolumab Daratumumab + Dexamethasone + Nivolumab + Pomalidomide Lirilumab + Nivolumab | An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma | Completed | USA | POL | ITA | GRC | FRA | BEL | 0 |
| NCT04323046 | Phase I | Ipilimumab Ipilimumab + Nivolumab Nivolumab | Immunotherapy (Nivolumab and Ipilimumab) Before and After Surgery for the Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults | Recruiting | USA | ISR | CHE | AUS | 0 |
| NCT02750514 | Phase II | Dasatinib + Nivolumab Nivolumab + Relatlimab Nivolumab Linrodostat + Nivolumab | An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung) | Terminated | USA | ITA | FRA | ESP | CHE | CAN | AUT | AUS | 0 |
| NCT02483247 | Phase Ib/II | Paclitaxel Doxorubicin Capecitabine Nivolumab Sunitinib Pembrolizumab Amcasertib | A Study of BBI503 in Combination With Selected Anti-Cancer Therapeutics in Adult Patients With Advanced Cancer | Completed | USA | CAN | 0 |
| NCT04581382 | Phase I | Pembrolizumab Nivolumab | Radiation Therapy, Plasma Exchange, and Immunotherapy (Pembrolizumab or Nivolumab) for the Treatment of Melanoma | Active, not recruiting | USA | 0 |
| NCT02632409 | Phase III | Nivolumab | A Study of Adjuvant Nivolumab Versus Placebo Post-Surgical Removal of High Risk Invasive Urothelial Carcinoma | Active, not recruiting | USA | SWE | ROU | POL | NLD | ITA | ISR | IRL | GRC | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BRA | BEL | AUT | AUS | ARG | 9 |
| NCT02426892 | Phase II | Nivolumab | Nivolumab and HPV-16 Vaccination in Patients With HPV-16 Positive Incurable Solid Tumors | Completed | USA | 0 |
| NCT02775292 | Phase I | Aldesleukin + Cyclophosphamide + Fludarabine Nivolumab NY-ESO-1 peptide vaccine | Gene-Modified T Cells, Vaccine Therapy, and Nivolumab in Treating Patients With Stage IV or Locally Advanced Solid Tumors Expressing NY-ESO-1 | Completed | USA | 0 |
| NCT02339571 | Phase II | Sargramostim Nivolumab Ipilimumab | Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery | Recruiting | USA | 0 |
| NCT04159818 | Phase II | Nivolumab Doxorubicin + Nivolumab Cisplatin + Nivolumab | Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients (TONIC-2) | Recruiting | NLD | 0 |
| NCT02840994 | Phase Ib/II | CV301 + Nivolumab Nivolumab | A Trial of CV301 in Combination With Nivolumab Versus Nivolumab in Subjects With Previously Treated Non-Small Cell Lung Cancer | Completed | USA | 0 |
| NCT04021108 | Phase II | Nivolumab Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | Phase II Study of Short Course FOLFOX Chemotherapy With Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L) | Active, not recruiting | USA | 0 |
| NCT04464759 | Phase Ib/II | Nivolumab Hydroxychloroquine + Ipilimumab + Nivolumab Hydroxychloroquine + Nivolumab | A Study of Nivolumab and Hydroxychloroquine or Nivolumab/Ipilimumab and Hydroxychloroquine in Advanced Melanoma (LIMIT) | Recruiting | USA | 0 |
| NCT02467361 | Phase Ib/II | Nivolumab Pembrolizumab Ipilimumab Napabucasin | A Study of BBI608 Administered in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Cancers | Completed | USA | 0 |
| NCT03816345 | Phase I | Nivolumab | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | Recruiting | USA | CAN | 0 |
| NCT04340193 | Phase III | Ipilimumab + Nivolumab Nivolumab | A Study of Nivolumab and Ipilimumab in Combination With Transarterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer (CheckMate 74W) | Completed | USA | POL | ITA | FRA | ESP | DEU | CZE | CAN | BEL | AUT | AUS | 8 |
| NCT03171025 | Phase II | Nivolumab | Adjuvant Nivolumab Following Chemo-Radiation in Localized Muscle-Invasive Bladder Cancer (NEXT) | Active, not recruiting | USA | 0 |
| NCT03838263 | Phase II | Nivolumab | Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer (IMMUNEBOOST) | Active, not recruiting | FRA | 0 |
| NCT03634800 | Phase II | Nivolumab | Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M) (RISE-M) | Terminated | USA | 0 |
| NCT05148546 | Phase II | Ipilimumab + Nivolumab Nivolumab Nivolumab + Relatlimab | Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer (NESCIO) | Recruiting | NLD | GBR | 0 |
| NCT03812562 | Phase I | Nivolumab | Nivolumab and Yttrium-90 in Treating Patients With Liver Cancer Undergoing Surgical Resection | Terminated | USA | 0 |
| NCT05743270 | Phase II | Cisplatin Nivolumab Cisplatin + RP3 Carboplatin + Paclitaxel + RP3 | Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN | Withdrawn | USA | POL | GRC | GBR | FRA | ESP | DEU | CZE | 0 |
| NCT02017717 | Phase III | Nivolumab Bevacizumab Ipilimumab + Nivolumab | A Randomized Study of Nivolumab Versus Bevacizumab and a Safety Study of Nivolumab in Adult Subjects With Recurrent Glioblastoma (GBM) (CheckMate 143) | Completed | USA | POL | NLD | ITA | GBR | FRA | ESP | DNK | DEU | CHE | BEL | AUS | 0 |
| NCT04099251 | Phase III | Nivolumab | Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate76K) | Active, not recruiting | USA | SWE | ROU | POL | NOR | NLD | ITA | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 0 |
| NCT03335540 | Phase I | Linrodostat + Nivolumab Nivolumab + Relatlimab Cabiralizumab + Nivolumab Lirilumab + Nivolumab BMS-986156 + Nivolumab Ipilimumab + Nivolumab Nivolumab | An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment | Completed | USA | 0 |
| NCT03685890 | Phase Ib/II | Nivolumab | Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion (NivoILP) | Recruiting | SWE | NLD | 0 |
| NCT04008030 | Phase III | Nivolumab Fluorouracil + Irinotecan + Leucovorin Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab Ipilimumab + Nivolumab | A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW) | Recruiting | USA | TUR | ROU | NOR | NLD | ITA | IRL | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 4 |
| NCT04322643 | Phase II | Durvalumab Pembrolizumab Avelumab Nivolumab Atezolizumab | Intermittent Checkpoint Inhibitor Therapy In Patients With Advanced Urothelial Carcinoma | Completed | USA | 0 |
| NCT04013542 | Phase I | Ipilimumab + Nivolumab Nivolumab | Ipilimumab and Nivolumab in Combination With Radiation Therapy in Treating Patients With Stage 2-3 Non-small Lung Cancer | Active, not recruiting | USA | 0 |
| NCT03382912 | Phase II | Nivolumab + Pegilodecakin Nivolumab | Study of AM0010 With NivolumabStudy of AM0010 With Nivolumab Compared to Nivolumab Alone Second-line Tx in Patients With Metastatic Non-Small Cell Lung Cancer (Cypress 2) | Terminated | USA | 0 |
| NCT03776487 | Phase Ib/II | Fluorouracil + Oxaliplatin Nivolumab Ipilimumab + Nivolumab Fluorouracil + Ipilimumab + Nivolumab | Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer | Active, not recruiting | USA | 0 |
| NCT03844256 | Phase Ib/II | Nivolumab Ipilimumab + Nivolumab | A Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study (CRIMI) | Recruiting | NLD | 0 |
| NCT04901988 | Phase II | Nivolumab | Circulating Tumour DNA guidEd Therapy for Stage IIB/C mElanoma After surgiCal resecTION (DETECTION) | Terminated | GBR | 0 |
| NCT02781506 | Phase II | Nivolumab | Nivolumab and Stereotactic Ablative Radiation Therapy Versus Nivolumab Alone for Metastatic Renal Cancer | Terminated | USA | 0 |
| NCT04019964 | Phase II | Nivolumab | Nivolumab in Biochemically Recurrent dMMR Prostate Cancer | Recruiting | USA | 0 |
| NCT02857426 | Phase II | Nivolumab | A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL) (CheckMate 647) | Completed | USA | ITA | ISR | HUN | FRA | DEU | CZE | CAN | BRA | 4 |
| NCT03743766 | Phase II | Relatlimab Nivolumab + Relatlimab Nivolumab | Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting | Completed | USA | 0 |
| NCT02576509 | Phase III | Nivolumab Sorafenib | A Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma | Completed | USA | SWE | POL | ITA | ISR | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 7 |
| NCT02518958 | Phase I | Nivolumab | A Phase I, Open-Label, Multiple Ascending Dose Study of RRx-001 and Nivolumab | Completed | USA | 0 |
| NCT03406247 | Phase II | Ipilimumab + Nivolumab Nivolumab | Immunotherapy in Head and Neck Squamous Cell Carcinoma : Phase 2 Trial Evaluating the Efficacy and the Toxicity of Nivolumab Alone, and of the Combination Nivolumab and Ipilimumab (ADJORL1) | Recruiting | FRA | 0 |
| NCT02451982 | Phase Ib/II | Nivolumab Cyclophosphamide + GVAX pancreatic cancer vaccine | Neoadjuvant/Adjuvant GVAX Pancreas Vaccine (With CY) With or Without Nivolumab Trial for Surgically Resectable Pancreatic Cancer | Recruiting | USA | 0 |
| NCT04062656 | Phase II | Nivolumab + Relatlimab Nivolumab Docetaxel + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG (IMAGINE) | Active, not recruiting | DEU | 0 |
| NCT04204837 | Phase II | Nivolumab + Relatlimab Nivolumab | Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin | Recruiting | AUT | 0 |
| NCT03959761 | Phase Ib/II | Nivolumab | Tolerance of Intraperitoneal (IP) Nivolumab After Extensive Debulking Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Ovarian Carcinoma (ICONIC) | Unknown status | FRA | 0 |
| NCT02156804 | Phase II | Nivolumab | A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172) | Completed | SWE | ROU | POL | NOR | NLD | LUX | ITA | IRL | HUN | GRC | GBR | FIN | ESP | DEU | CZE | CHE | BEL | AUT | 2 |
| NCT03487666 | Phase II | Capecitabine + Nivolumab Capecitabine Nivolumab | OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual Disease | Completed | USA | 0 |
| NCT02664181 | Phase II | Nivolumab Decitabine + Nivolumab + Tetrahydrouridine | Pharmacologically Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With Non-Small Cell Lung Cancer (PRECISE) | Completed | USA | 0 |
| NCT05491616 | Phase II | Nivolumab | Nivolumab During Active Surveillance After Neoadjuvant Chemoradiation for Esophageal Cancer: SANO-3 Study (SANO-3) | Recruiting | NLD | 0 |
| NCT03610711 | Phase Ib/II | Nivolumab + Relatlimab Nivolumab | REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer (REACTION) | Active, not recruiting | USA | 0 |
| NCT02428192 | Phase II | Nivolumab | Nivolumab in Treating Patients With Advanced Uterine Leiomyosarcoma | Active, not recruiting | USA | 0 |
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