Therapy Detail
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| Therapy Name | Tislelizumab |
| Synonyms | |
| Therapy Description |
Tevimbra (tislelizumab) is a human monoclonal antibody that targets PD-1 (PDCD1), thereby blocking the binding of PD-L1 (CD274) and potentially resulting in activation of a T-cell immune response against tumor cells (PMID: 32769013, PMID: 32561638, PMID: 32540858). Tevimbra (tislelizumab) is FDA-approved for use in patients with unresectable or metastatic esophageal squamous cell carcinoma (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Tislelizumab | Tevimbra | BGB-A317|tislelizumab-jsgr | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 | Tevimbra (tislelizumab) is a human monoclonal antibody that targets PD-1 (PDCD1), thereby blocking the binding of PD-L1 (CD274) and potentially resulting in activation of a T-cell immune response against tumor cells (PMID: 32769013, PMID: 32561638, PMID: 32540858). Tevimbra (tislelizumab) is FDA-approved for use in patients with unresectable or metastatic esophageal squamous cell carcinoma (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| PMS2 negative | rectum cancer | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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 | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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 | endometrial carcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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 | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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 | rectum cancer | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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, MSH2, PMS2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| CD274 positive | esophagus squamous cell carcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) in combination with chemotherapy is included in guidelines as first-line therapy for patients with advanced esophageal squamous carcinoma expressing CD274 (PD-L1, TAP >/= 5%) (PMID: 39986705; ESMO.org). | 39986705 detail... |
| CD274 positive | esophagus squamous cell carcinoma | sensitive | Tislelizumab | Clinical Study - Cohort | Actionable | In a Phase III trial (RATIONALE-302), second-line Tevimbra (tislelizumab) improved median overall survival (mOS) (8.6 vs 6.3 mo; HR 0.70, p=0.0001) and objective response rate (20.3% vs 9.8%) compared to chemotherapy in advanced esophageal squamous cell carcinoma patients, and CD274 (PD-L1)-positive (TAP>=10%) patients treated with Tevimbra (tislelizumab) (n=89) showed improved mOS (10.3 vs 6.8 mo; HR 0.54, p=0.0006) compared to those patients treated with chemotherapy (n=68) (PMID: 35442766; NCT03430843). | 35442766 |
| PMS2 negative | colon cancer | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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... |
| MSH6 negative | colon cancer | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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... |
| PMS2 negative | endometrial carcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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 | appendix adenocarcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) is included in guidelines (category 2A) for patients with advanced or metastatic appendiceal adenocarcinoma 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... |
| MSH2 negative | rectum cancer | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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... |
| MSH2 negative | appendix adenocarcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) is included in guidelines (category 2A) for patients with advanced or metastatic appendiceal adenocarcinoma 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... |
| MSH2 negative | small intestine adenocarcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) is included in guidelines as systemic therapy (category 2A) 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... |
| MLH1 negative | rectum cancer | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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 | appendix adenocarcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) is included in guidelines (category 2A) for patients with advanced or metastatic appendiceal adenocarcinoma 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 | endometrial carcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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 | colon cancer | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) 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... |
| PMS2 negative | appendix adenocarcinoma | sensitive | Tislelizumab | Guideline | Actionable | Tevimbra (tislelizumab) is included in guidelines (category 2A) for patients with advanced or metastatic appendiceal adenocarcinoma 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 |
|---|---|---|---|---|---|---|
| NCT06167785 | Phase II | Zanubrutinib Tislelizumab + Zanubrutinib Tislelizumab | A Study to Evaluate Zanubrutinib and Tislelizumab in Progressive Lymphoma Post CAR-T (ZeTA) | Recruiting | CAN | 0 |
| NCT04866017 | Phase III | Durvalumab BGBA1217 + Tislelizumab Tislelizumab | A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | Terminated | USA | ESP | AUS | 2 |
| NCT05366829 | Phase II | Tislelizumab | Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma | Recruiting | USA | 0 |
| NCT06332274 | Phase III | Tislelizumab | tislelizUMaB in canceR Patients With molEcuLar residuaL Disease (UMBRELLA) | Recruiting | FRA | 0 |
| NCT05635708 | Phase II | Nab-paclitaxel Cisplatin BGB-15025 + Tislelizumab BGB-A445 + Tislelizumab Paclitaxel Tislelizumab Carboplatin Pemetrexed Disodium LBL-007 + Tislelizumab | A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer | Active, not recruiting | USA | ROU | ITA | FRA | ESP | CAN | BRA | AUS | 7 |
| NCT05245760 | Phase II | Tislelizumab | ChemoRadiation And Tislelizumab for Esophageal/EGJ Cancer (CRATER) | Withdrawn | USA | 0 |
| NCT04837859 | Phase II | Tislelizumab Dacarbazine + Doxorubicin + Tislelizumab + Vinblastine | Phase II Trial of Individualized Immunotherapy in Early-Stage Unfavorable Classical Hodgkin Lymphoma (INDIE) | Recruiting | DEU | 0 |
| NCT05622071 | Phase II | Tislelizumab | Testing Immunotherapy for Patients With Liver Cancer and Moderately Altered Liver Functions (HESTIA) | Completed | FRA | 0 |
| NCT07205731 | Phase II | Tislelizumab | Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma (SAFE ESO) | Recruiting | FRA | 0 |
| NCT03430843 | Phase III | Docetaxel Paclitaxel Tislelizumab Irinotecan | A Study of BGB-A317 Versus Chemotherapy as Second Line Treatment in Patients With Advanced Esophageal Squamous Cell Carcinoma | Completed | USA | ITA | GBR | FRA | ESP | DEU | BEL | 4 |
| NCT04318080 | Phase II | Tislelizumab | Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma | Completed | USA | AUS | 0 |
| NCT04813107 | Phase Ib/II | APL-1202 + Tislelizumab Tislelizumab | A Study to Evaluate the Safety and Efficacy of Oral APL-1202 in Combination With Tislelizumab Compared to Tislelizumab Alone as Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (ANTICIPATE) | Unknown status | USA | 1 |
| NCT05014815 | Phase II | BGBA1217 + Tislelizumab Tislelizumab | Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer | Completed | USA | GRC | FRA | ESP | AUT | AUS | 2 |
| NCT03412773 | Phase III | Tislelizumab Sorafenib | Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC | Completed | USA | POL | ITA | GBR | FRA | ESP | DEU | CZE | 3 |
| NCT05977673 | Phase II | Tislelizumab | Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy: a Phase II, Open-label Study (FIL_Tisle-HL) | Recruiting | ITA | 0 |
| NCT04732494 | Phase II | BGBA1217 + Tislelizumab Tislelizumab | AdvanTIG-203: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma | Completed | FRA | ESP | 4 |
| NCT04802876 | Phase II | Tislelizumab Spartalizumab | Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors (ACROPOLI) | Active, not recruiting | ESP | 0 |
| NCT03783442 | Phase III | Cisplatin Paclitaxel Tislelizumab Oxaliplatin Fluorouracil Capecitabine | A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma | Completed | USA | ROU | POL | ITA | GBR | FRA | ESP | DEU | CZE | BEL | AUS | 5 |
| NCT05909904 | Phase II | LBL-007 + Tislelizumab Tislelizumab BGB-A425 + Tislelizumab BGB-A425 + LBL-007 + Tislelizumab | Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma | Active, not recruiting | USA | TUR | ITA | GBR | FRA | ESP | CAN | AUS | 6 |
| NCT02407990 | Phase I | Tislelizumab | Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors | Completed | USA | NZL | AUS | 2 |
| NCT04164199 | Phase III | Pamiparib + Tislelizumab Pemetrexed Disodium + Tislelizumab Tislelizumab Capecitabine + Tislelizumab Pamiparib | Study of Tislelizumab and/or Pamiparib Containing Treatments in Participants With Advanced Malignancies | Enrolling by invitation | USA | TUR | POL | NZL | ITA | FRA | AUS | 6 |
| NCT06529523 | Phase II | Tislelizumab | Tislelizumab in People With Colorectal Cancer | Recruiting | USA | 1 |
| NCT03419897 | Phase II | Tislelizumab | Study of BGB-A317 in Patients With Previously Treated Unresectable HCC | Completed | POL | ITA | GBR | FRA | ESP | DEU | 2 |
| NCT05502250 | Phase II | Cisplatin + Gemcitabine + Tislelizumab Tislelizumab | Tislelizumab, Gemcitabine and Cisplatin for R/R Hodgkin Lymphoma Followed by Tislelizumab Consolidation in Patients in Metabolic Complete Remission (HOVON164HL) | Recruiting | NLD | DNK | BEL | 0 |
| NCT04746924 | Phase III | Tislelizumab BGBA1217 + Tislelizumab Pembrolizumab | A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer | Active, not recruiting | USA | TUR | POL | NLD | ITA | FRA | ESP | DEU | BRA | AUS | ARG | 8 |
| NCT07264647 | Phase II | Tislelizumab | Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC) | Recruiting | ITA | 0 |
| NCT04952597 | Phase II | Tislelizumab BGBA1217 + Tislelizumab | Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer | Completed | USA | 2 |
| NCT03745222 | Phase III | Tislelizumab Cisplatin + Etoposide + Tislelizumab Carboplatin + Paclitaxel + Tislelizumab Cisplatin + Etoposide Carboplatin + Paclitaxel | A Study of Tislelizumab (BGB-A317) Plus Chemoradiotherapy Followed by Tislelizumab Monotherapy in Newly Diagnosed, Stage III Subjects With Locally Advanced, Unresectable Non-small Cell Lung Cancer (RATIONALE001) | Terminated | USA | ROU | POL | NZL | NLD | ITA | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DEU | CAN | BEL | 7 |
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