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 69 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, with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemotherapy for patients with esophageal or gastroesophageal carcinoma, and in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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 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 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
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 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 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 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 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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04700072 Phase Ib/II Lenvatinib + MK-1308A Lenvatinib + Pembrolizumab Substudy 02D: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02) Recruiting USA 0
NCT04393350 Phase II Lenvatinib + Pembrolizumab Lenvatinib and Pembrolizumab Before Surgery for the Treatment of Locally Advanced Non-Metastatic Kidney Cancer 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) Active, not recruiting USA | CAN 20
NCT04704219 Phase II Lenvatinib + Pembrolizumab Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61) (KEYNOTE-B61) Recruiting USA | CAN 9
NCT04736706 Phase III Lenvatinib + Pembrolizumab Lenvatinib + MK-1308A Lenvatinib + Pembrolizumab + PT 2977 A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012) Recruiting USA 3
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
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
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
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 13
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
NCT04784247 Phase II Lenvatinib + Pembrolizumab Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma Recruiting USA 0
NCT04729348 Phase II Lenvatinib + Pembrolizumab Pembrolizumab And Lenvatinib In Leptomeningeal Metastases Not yet recruiting USA 0
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
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
NCT04869137 Phase II Lenvatinib + Pembrolizumab Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma 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
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 | CAN 5
NCT03006926 Phase I Lenvatinib + Pembrolizumab A Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma Active, not recruiting USA 6
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 16
NCT04427293 Phase I Lenvatinib + Pembrolizumab Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC) Recruiting USA 0
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
NCT04645602 Phase II Lenvatinib + Pembrolizumab Lenvatinib and Pembrolizumab Combination Therapy In HPV-associated Recurrent Respiratory Papilloma Patients With Laryngeal, Tracheal, and/or Pulmonary Involvement Not yet recruiting USA 0
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
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
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
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
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 | CAN 5
NCT04209660 Phase II Lenvatinib + Pembrolizumab Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers Recruiting USA 0
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 23
NCT04776148 Phase III Regorafenib Trifluridine-tipiracil hydrochloride Lenvatinib + Pembrolizumab Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017) Recruiting USA 8
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
NCT04865887 Phase II Lenvatinib + Pembrolizumab Pembrolizumab and Lenvatinib in Advanced Cervical Cancer Not yet 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


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