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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 149 PD-L1/PD-1 antibody 124 | 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 |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT05245760 | Phase II | Tislelizumab | ChemoRadiation And Tislelizumab for Esophageal/EGJ Cancer (CRATER) | Withdrawn | USA | 0 |
| NCT05366829 | Phase II | Tislelizumab | Tislelizumab Consolidation After Liver-Directed Therapy for Hepatocellular Carcinoma | Recruiting | USA | 0 |
| NCT06529523 | Phase II | Tislelizumab | Tislelizumab in People With Colorectal Cancer | Recruiting | USA | 1 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT05635708 | Phase II | Nab-paclitaxel Cisplatin 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT05622071 | Phase II | Tislelizumab | Testing Immunotherapy for Patients With Liver Cancer and Moderately Altered Liver Functions (HESTIA) | Recruiting | FRA | 0 |
| 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 |
| NCT06919705 | Phase II | Zanubrutinib Tislelizumab Tislelizumab + Zanubrutinib | Testing Zanubrutinib and Tislelizumab as Well as Standard of Care for the Treatment of Patients With Progressive Lymphoma Post Anti-CD19 CAR-T Cell Therapy (OZUHN-024) | Not yet recruiting | 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 |
| 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 |
| NCT03419897 | Phase II | Tislelizumab | Study of BGB-A317 in Patients With Previously Treated Unresectable HCC | Completed | POL | ITA | GBR | FRA | ESP | DEU | 2 |
| 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 |
| NCT06332274 | Phase III | Tislelizumab | tislelizUMaB in canceR Patients With molEcuLar residuaL Disease (UMBRELLA) | Not yet recruiting | FRA | 0 |
| NCT04318080 | Phase II | Tislelizumab | Tislelizumab in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma | Completed | USA | AUS | 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 |
| 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 |
| 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 |
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