Therapy Detail
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| Therapy Name | Lenvatinib + Pembrolizumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Lenvatinib | Lenvima | E7080 | FGFR Inhibitor (Pan) 18 KIT Inhibitor 51 PDGFR Inhibitor (Pan) 27 RET Inhibitor 39 VEGFR Inhibitor (Pan) 32 | Lenvima (lenvatinib) inhibits VEGFR, FGFR, PDGFR, KIT, and RET, and suppresses cell proliferation and angiogenesis (PMID: 21781317, PMID: 25295214, PMID: 17943726). Lenvima (lenvatinib) is FDA approved for use in patients with radioactive iodine-refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma, in combination with Afinitor (everolimus) for renal cell carcinoma, and in combination with Pembrolizumab for endometrial carcinoma that is not MSI-H or dMMR (FDA.gov). |
| Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 68 | Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, PD-L1 expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, with axitinib in RCC, and with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | endometrial cancer | not applicable | Lenvatinib + Pembrolizumab | Phase Ib/II | Actionable | Ina Phase Ib/II trial, Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination treatment demonstrated safety and efficacy, resulted in an objective response rate of 52% (12/23) in patients with metastatic endometrial cancer, with a median duration of response not evaluable, and a median progression-free survival of 9.7 months (PMID: 31961766; NCT02501096). | 31961766 |
| Unknown unknown | stomach cancer | not applicable | Lenvatinib + Pembrolizumab | Phase II | Actionable | In a Phase II trial (EPOC1706), the combination of Lenvima (lenvatinib) and Keytruda (pembrolizumab) treatment in patients with either stomach cancer or gastroesophageal junction cancer resulted in a 69% (20/29) objective response rate, a disease control rate of 100% (29/29), a median progression-free survival of 7.1 months, and a median overall survival that had not yet been reached, and 8 patients were still experiencing an ongoing response at data cut-off (PMID: 32589866; NCT03609359). | 32589866 |
| Unknown unknown | gastroesophageal junction adenocarcinoma | not applicable | Lenvatinib + Pembrolizumab | Phase II | Actionable | In a Phase II trial (EPOC1706), the combination of Lenvima (lenvatinib) and Keytruda (pembrolizumab) treatment in patients with either stomach cancer or gastroesophageal junction cancer resulted in a 69% (20/29) objective response rate, a disease control rate of 100% (29/29), a median progression-free survival of 7.1 months, and a median overall survival that had not yet been reached, and 8 patients were still experiencing an ongoing response at data cut-off (PMID: 32589866; NCT03609359). | 32589866 |
| Unknown unknown | melanoma | not applicable | Lenvatinib + Pembrolizumab | Phase Ib/II | Actionable | Ina Phase Ib/II trial, Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination treatment demonstrated safety and efficacy, resulted in an objective response rate of 48% (10/21) in patients with metastatic melanoma, with a median duration of response of 12.5 months, and a median progression-free survival of 5.5 months (PMID: 31961766; NCT02501096). | 31961766 |
| Unknown unknown | transitional cell carcinoma | not applicable | Lenvatinib + Pembrolizumab | Phase Ib/II | Actionable | Ina Phase Ib/II trial, Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination treatment demonstrated safety and efficacy, resulted in an objective response rate of 25% (5/20) in patients with metastatic urothelial cancer, with a median duration of response not evaluable, and a median progression-free survival of 5.4 months (PMID: 31961766; NCT02501096). | 31961766 |
| Unknown unknown | endometrial carcinoma | not applicable | Lenvatinib + Pembrolizumab | FDA approved | Actionable | In a Phase II trial (Study 111/KEYNOTE-146) that supported FDA approval, Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination treatment resulted in an objective response rate of 35.6% (16/45) in patients with endometrial carcinoma that was not MSI-H or dMMR (PMID: 30922731; NCT02501096). | detail... detail... 30922731 |
| Unknown unknown | head and neck squamous cell carcinoma | not applicable | Lenvatinib + Pembrolizumab | Phase Ib/II | Actionable | Ina Phase Ib/II trial, Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination treatment demonstrated safety and efficacy, resulted in an objective response rate of 46% (10/22) in patients with metastatic head and neck squamous cell carcinoma, with a median duration of response of 8.2 months, and a median progression-free survival of 4.7 months (PMID: 31961766; NCT02501096). | 31961766 |
| Unknown unknown | renal cell carcinoma | not applicable | Lenvatinib + Pembrolizumab | Phase Ib/II | Actionable | Ina Phase Ib/II trial, Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination treatment demonstrated safety and efficacy, resulted in an objective response rate of 70% (21/30) in patients with metastatic renal cell carcinoma, with a median duration of response of 20.0 months, and a median progression-free survival of 19.8 months (PMID: 31961766; NCT02501096). | 31961766 |
| Unknown unknown | lung non-small cell carcinoma | not applicable | Lenvatinib + Pembrolizumab | Phase Ib/II | Actionable | In a Phase Ib/II trial, Lenvima (lenvatinib) and Keytruda (pembrolizumab) combination treatment demonstrated safety and efficacy, resulted in an objective response rate of 33% (7/21) in patients with metastatic non-small cell lung cancer, with a median duration of response of 10.9 months, and a median progression-free survival of 5.9 months (PMID: 31961766; NCT02501096). | 31961766 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04171622 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib and Pembrolizumab for the Treatment of Stage IVB Locally Advanced and Unresectable or Stage IVC Metastatic Anaplastic Thyroid Cancer | Not yet recruiting | USA | 0 |
| NCT03884101 | Phase III | Carboplatin + Paclitaxel Lenvatinib + Pembrolizumab | Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) | Recruiting | USA | CAN | 20 |
| NCT03829332 | Phase III | Pembrolizumab Lenvatinib + Pembrolizumab | Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naive Non-small Cell Lung Cancer (NSCLC)(MK-7902-007/E7080-G000-314/LEAP-007) | Active, not recruiting | USA | CAN | 17 |
| NCT03776136 | Phase II | Lenvatinib + Pembrolizumab | Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 (PD-1/L1)-Exposed Participants (MK-7902-004/E7080-G000-225/LEAP-004) | Active, not recruiting | USA | CAN | 3 |
| NCT03516981 | Phase II | MK-1308 + Pembrolizumab MK-4280 + Pembrolizumab Lenvatinib + Pembrolizumab | A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495/KEYNOTE-495) | Recruiting | USA | CAN | 14 |
| NCT03006926 | Phase I | Lenvatinib + Pembrolizumab | A Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma | Active, not recruiting | USA | 6 |
| NCT04267120 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial) | Recruiting | USA | 0 |
| NCT02973997 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib in Treating Metastatic or Recurrent Differentiated Thyroid Cancer That Cannot Be Removed by Surgery | Active, not recruiting | USA | 0 |
| NCT04626479 | Phase Ib/II | Lenvatinib + MK-1308A Lenvatinib + MK-4280A Lenvatinib + Pembrolizumab Lenvatinib + Pembrolizumab + PT 2977 | Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) | Recruiting | USA | 3 |
| NCT04246177 | Phase III | Lenvatinib + Pembrolizumab | Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012) | Recruiting | USA | 22 |
| NCT04428151 | Phase II | Lenvatinib + Pembrolizumab Docetaxel Paclitaxel Capecitabine Cetuximab Lenvatinib | Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) | Recruiting | USA | CAN | 8 |
| NCT03797326 | Phase II | Lenvatinib + Pembrolizumab | Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) | Recruiting | USA | CAN | 8 |
| NCT04393350 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib and Pembrolizumab Before Surgery for the Treatment of Locally Advanced Non-Metastatic Kidney Cancer | Recruiting | USA | 0 |
| NCT03976375 | Phase III | Lenvatinib Lenvatinib + Pembrolizumab Docetaxel | Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008) | Recruiting | USA | CAN | 16 |
| NCT04729348 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab And Lenvatinib In Leptomeningeal Metastases | Not yet recruiting | USA | 0 |
| NCT04209660 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers | Recruiting | USA | 0 |
| NCT04199104 | Phase III | Lenvatinib + Pembrolizumab Pembrolizumab | A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010) (MK-7902-010) (LEAP-10) | Recruiting | USA | CAN | 17 |
| NCT03820986 | Phase III | Lenvatinib + Pembrolizumab Pembrolizumab | Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003) | Recruiting | USA | CAN | 15 |
| NCT04626518 | Phase Ib/II | MK-4280A Lenvatinib + Pembrolizumab Pembrolizumab + PT 2977 MK-1308A MK-4830 + Pembrolizumab Lenvatinib + PT 2977 | Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) | Recruiting | USA | 3 |
| NCT02811861 | Phase III | Everolimus + Lenvatinib Sunitinib Lenvatinib + Pembrolizumab | Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma | Active, not recruiting | USA | CAN | 18 |
| NCT03517449 | Phase III | Lenvatinib + Pembrolizumab Paclitaxel Doxorubicin | Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) | Active, not recruiting | USA | CAN | 19 |
| NCT04427293 | Phase I | Lenvatinib + Pembrolizumab | Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC) | Recruiting | USA | 0 |
| NCT03321630 | Phase II | Lenvatinib + Pembrolizumab | A Study of Lenvatinib, a Multi-targeted Tyrosine Kinase Inhibitor, Combined With Pembrolizumab (PD-1 Inhibitor) for the Treatment of Metastatic Gastroesophageal Cancer Patients Who Have Progressed on First or Subsequent Line Therapies | Recruiting | USA | 0 |
| NCT03713593 | Phase III | Lenvatinib Lenvatinib + Pembrolizumab | Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib as First-line Therapy in Participants With Advanced Hepatocellular Carcinoma (MK-7902-002/E7080-G000-311/LEAP-002) | Active, not recruiting | USA | CAN | 19 |
| NCT03898180 | Phase III | Lenvatinib + Pembrolizumab Pembrolizumab | Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) | Recruiting | USA | CAN | 18 |
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