Therapy Detail
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| Therapy Name | Cemiplimab |
| Synonyms | |
| Therapy Description |
Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cemiplimab | Libtayo | REGN2810|SAR439684 | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 132 | Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| MSH6 negative | rectum cancer | sensitive | Cemiplimab | Guideline | Actionable | Libtayo (cemiplimab) is included in guidelines (category 2A) for patients with advanced or metastatic rectal 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... |
| MSH6 negative | colon cancer | sensitive | Cemiplimab | Guideline | Actionable | Libtayo (cemiplimab) is included in guidelines (category 2A) 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... |
| MLH1 negative | rectum cancer | sensitive | Cemiplimab | Guideline | Actionable | Libtayo (cemiplimab) is included in guidelines (category 2A) for patients with advanced or metastatic rectal 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... |
| MLH1 negative | colon cancer | sensitive | Cemiplimab | Guideline | Actionable | Libtayo (cemiplimab) is included in guidelines (category 2A) 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04975152 | Phase I | Cemiplimab | Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma | Active, not recruiting | USA | 0 |
| NCT03889912 | Phase I | Cemiplimab | Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma | Active, not recruiting | USA | NLD | AUS | 0 |
| NCT04873375 | Phase II | Cemiplimab | Cemiplimab for Secondary Angiosarcomas | Completed | NLD | 0 |
| NCT02760498 | Phase II | Cemiplimab | Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma | Completed | USA | ITA | GRC | FRA | ESP | DEU | BRA | AUS | 0 |
| NCT05785767 | Phase II | Cemiplimab Cemiplimab + Fianlimab | A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) | Recruiting | USA | TUR | ISR | ESP | CAN | AUS | 5 |
| NCT06219317 | Phase II | Cemiplimab | Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC (ICARS) | Recruiting | NLD | ITA | FRA | ESP | BEL | 0 |
| NCT06385262 | Phase II | Cemiplimab Alirocumab + Cemiplimab | TOP 2301: Neoadjuvant Chemo for NSCLC | Recruiting | USA | 0 |
| NCT05317858 | Phase III | Pembrolizumab Cemiplimab Atezolizumab Nivolumab Ipilimumab | Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets (LIMITLESS) | Recruiting | USA | CAN | 1 |
| NCT07050186 | Phase II | Cemiplimab | Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma | Recruiting | USA | 0 |
| NCT06190951 | Phase II | Cemiplimab Cemiplimab + Fianlimab | A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | AUS | 0 |
| NCT03669718 | Phase II | Cemiplimab + ISA101b Cemiplimab | A Randomized Phase 2 Study of Cemiplimab +/- ISA101b in HPV16-Positive OPC | Active, not recruiting | USA | POL | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CZE | BRA | BEL | 1 |
| NCT07085572 | Phase II | Cemiplimab | Cemiplimab as Maintenance Treatment for Advanced Adrenocortical Cancer (INTERVAL) | Recruiting | ITA | 0 |
| NCT04154943 | Phase II | Cemiplimab | Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma | Active, not recruiting | USA | DEU | AUS | 0 |
| NCT05557591 | Phase II | Cemiplimab BNT116 + Cemiplimab | A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) | Active, not recruiting | USA | TUR | ESP | DEU | 3 |
| NCT05352672 | Phase III | Cemiplimab Cemiplimab + Fianlimab Pembrolizumab | Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma | Recruiting | USA | TUR | ROU | POL | NLD | ITA | IRL | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 5 |
| NCT04428671 | Phase I | Cemiplimab | Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer | Recruiting | USA | 0 |
| NCT03430063 | Phase II | Cemiplimab + Ipilimumab Cemiplimab | A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer | Terminated | USA | POL | GBR | FRA | ESP | DEU | BEL | 2 |
| NCT07101848 | Phase II | Cemiplimab | A PHASE II, RANDOMIZED TRIAL TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT VULVAR CANCER (BRAVA VULVAR) | Not yet recruiting | BRA | 0 |
| NCT04157985 | Phase III | Nivolumab Ipilimumab Cemiplimab Pembrolizumab Atezolizumab | Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors | Recruiting | USA | 0 |
| NCT06449313 | Phase II | Cemiplimab | Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement (NEO-SURG) | Recruiting | USA | 0 |
| NCT03916627 | Phase II | Cemiplimab | Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC | Active, not recruiting | USA | 0 |
| NCT06205836 | Phase II | Cemiplimab Cemiplimab + Fianlimab | Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer | Recruiting | USA | 0 |
| NCT03409614 | Phase III | Cemiplimab + Ipilimumab Cemiplimab | Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer | Completed | USA | TUR | SVK | ROU | POL | LTU | ITA | IRL | GRC | FRA | AUT | 7 |
| NCT07101822 | Phase II | Cemiplimab | A PHASE II, RANDOMIZED STUDY TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT PENILE CANCER (BRAVA PENILE) | Not yet recruiting | BRA | 0 |
| NCT06585410 | Phase III | Cemiplimab | Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma | Recruiting | USA | AUS | 0 |
| NCT06840782 | Cemiplimab Pembrolizumab Durvalumab + Tremelimumab Ipilimumab + Nivolumab Atezolizumab | First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients. (OliGRAIL) | Recruiting | FRA | 0 | |
| NCT05961709 | Phase II | Cemiplimab | The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer | Recruiting | USA | 0 |
| NCT06917573 | Phase II | Cemiplimab Carboplatin + Cemiplimab + Paclitaxel | PALACE: Cemiplimab Trial According to ctDNA Levels (PALACE) | Recruiting | ESP | 0 |
| NCT06465329 | Phase II | Cemiplimab + REGN7075 REGN7075 Cemiplimab | A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) | Recruiting | USA | TUR | FRA | ESP | DEU | BRA | 0 |
| NCT03477864 | Phase I | Ipilimumab Cemiplimab + Ipilimumab Cemiplimab | Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer | Withdrawn | 0 | |
| NCT04315701 | Phase II | Cemiplimab | A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer | Active, not recruiting | USA | 0 |
| NCT02383212 | Phase I | Carboplatin + Cemiplimab + Docetaxel Carboplatin + Cemiplimab + Pemetrexed Disodium Cemiplimab + Cyclophosphamide + Sargramostim Cemiplimab + Cyclophosphamide Cemiplimab Carboplatin + Cemiplimab + Paclitaxel Cemiplimab + Docetaxel | Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies | Completed | USA | ESP | AUS | 0 |
| NCT06162572 | Phase Ib/II | Cemiplimab + S095029 Cemiplimab + Sym024 Cemiplimab + Sym023 Cemiplimab | Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) | Recruiting | USA | ROU | ITA | HUN | GBR | FRA | ESP | BRA | BEL | AUT | AUS | ARG | 3 |
| NCT03257267 | Phase III | Irinotecan Gemcitabine Vinorelbine Pemetrexed Disodium Cemiplimab Topotecan | Study of REGN2810 in Adults With Cervical Cancer | Completed | USA | POL | ITA | GRC | GBR | ESP | CAN | BRA | BEL | AUS | 4 |
| NCT05967884 | Phase II | Cemiplimab Cemiplimab + Dupilumab | PD-1 +/- IL-4 Inhibition in ER+ Breast Cancer | Unknown status | CAN | 0 |
| NCT06981325 | Phase II | Cemiplimab | Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients (CEMI-first) | Recruiting | DEU | 0 |
| NCT05929664 | Phase II | Cemiplimab | Cemiplimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery | Recruiting | USA | 0 |
| NCT04387084 | Phase I | Durvalumab Pembrolizumab Retifanlimab Avelumab Cemiplimab Toripalimab-tpzi Atezolizumab Nivolumab Dostarlimab-gxly | Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy | Active, not recruiting | USA | 0 |
| NCT07020065 | Phase II | Carboplatin + Cemiplimab + Gemcitabine Carboplatin + Cemiplimab + Pemetrexed Disodium Cemiplimab Carboplatin + Cemiplimab + Paclitaxel | Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50% | Not yet recruiting | CHE | 0 |
| NCT04988074 | Phase II | Cemiplimab Carboplatin + Cemiplimab + Paclitaxel | Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca (MINIMA) | Recruiting | USA | 0 |
| NCT04339062 | Phase I | Cemiplimab Cemiplimab + Everolimus + Prednisone Cemiplimab + Prednisone + Sirolimus | Cemiplimab in AlloSCT/SOT Recipients With CSCC (CONTRAC) | Completed | USA | 0 |
| NCT02651662 | Phase I | Cemiplimab Cemiplimab + Odronextamab | Study of REGN2810 and REGN1979 in Patients With Lymphoma | Active, not recruiting | USA | POL | ISR | ESP | DEU | AUT | 0 |
| NCT07223541 | Phase II | Cemiplimab Cemiplimab + Fianlimab | Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma (LAG-BOOST) | Not yet recruiting | USA | 0 |
| NCT06568172 | Phase III | Cemiplimab | Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer | Recruiting | USA | CAN | AUS | 0 |
| NCT03690869 | Phase Ib/II | Cemiplimab | REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma | Terminated | USA | 0 |
| NCT04526899 | Phase II | Cemiplimab BNT111 BNT111 + Cemiplimab | A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment | Active, not recruiting | USA | POL | ITA | GBR | ESP | DEU | AUS | 0 |
| NCT05538988 | Phase Ib/II | Cemiplimab | BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma (BIOSELECT) | Withdrawn | CAN | 0 |
| NCT03969004 | Phase III | Cemiplimab | Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma | Active, not recruiting | USA | POL | NZL | ITA | IRL | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 2 |
| NCT06743581 | Phase Ib/II | Cemiplimab Dupilumab | Phase I/II Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer (Dupi-Cemi) | Not yet recruiting | CAN | 0 |
| NCT05840770 | Phase II | Cemiplimab | Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer | Withdrawn | 0 | |
| NCT05574101 | Phase II | Cemiplimab | A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer | Active, not recruiting | USA | 0 |
| NCT04632433 | Phase II | Cemiplimab | Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma | Active, not recruiting | ITA | 0 |
| NCT05878288 | Phase II | Cemiplimab | Deep sequencIng in Cutaneous Squamous CEll caRciNomas (DISCERN) | Active, not recruiting | AUS | 0 |
| NCT06931717 | Phase III | Cemiplimab | A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy. (ARCH) | Recruiting | ITA | IRL | FRA | EST | ESP | DEU | CHE | AUT | 1 |
| NCT05401786 | Phase II | Cemiplimab Ipilimumab | Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC (RAD-IO) | Recruiting | NLD | 0 |
| NCT05344209 | Phase II | Atezolizumab Pembrolizumab Cemiplimab Cemiplimab + Sargramostim + UV1 Telomerase peptide vaccine Pembrolizumab + Sargramostim + UV1 Telomerase peptide vaccine Atezolizumab + Sargramostim + UV1 Telomerase peptide vaccine | Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer (LUNGVAC) | Recruiting | NOR | 0 |
| NCT03565783 | Phase II | Cemiplimab | Study of REGN2810 Prior to Surgery in Patients With Advanced-Stage, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck | Active, not recruiting | USA | 0 |
| NCT03132636 | Phase II | Cemiplimab | PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy | Completed | USA | ITA | GRC | FRA | ESP | DEU | CHE | CAN | BEL | AUT | 0 |
| NCT03580694 | Phase I | Cemiplimab + REGN4659 Cemiplimab | Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) | Terminated | USA | 0 |
| NCT06623656 | Phase II | Cemiplimab | Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC | Recruiting | USA | 0 |
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