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) 26 KIT Inhibitor 57 PDGFR Inhibitor (Pan) 30 RET Inhibitor 52 VEGFR Inhibitor (Pan) 36 | 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 Keytruda (pembrolizumab) as first line, or 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 147 PD-L1/PD-1 antibody 117 | 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 SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemotherapy in NSCLC, 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 or lenvatinib 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, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemotherapy for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, and in combination with chemoradiation for cervical cancer (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 |
|---|---|---|---|---|---|---|
| NCT06030037 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab/Lenvatinib With and Without Responder-derived FMT in Relapsed/Refractory Melanoma | Not yet recruiting | USA | 0 |
| 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) | Active, not recruiting | USA | ITA | FRA | ESP | AUS | 3 |
| NCT03006926 | Phase I | Lenvatinib + Pembrolizumab | A Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma | Completed | USA | ITA | GBR | FRA | ESP | 2 |
| NCT04626518 | Phase Ib/II | MK-4280A Lenvatinib + Pembrolizumab Belzutifan + Pembrolizumab MK-1308A MK-4830 + Pembrolizumab Belzutifan + Lenvatinib | Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B) | Active, not recruiting | USA | NZL | NLD | GBR | FRA | ESP | CAN | AUS | 5 |
| 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 | ITA | GBR | ESP | DEU | CAN | BEL | AUT | AUS | 13 |
| NCT04875585 | Phase II | Lenvatinib + Pembrolizumab | Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC (INNWOP1) | Recruiting | AUT | 0 |
| NCT04209660 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers | Recruiting | USA | 0 |
| NCT04848337 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib in Advanced/Metastatic Neuroendocrine Prostate Cancer (PLANE-PC) | Recruiting | USA | 0 |
| NCT04207086 | Phase II | Lenvatinib + Pembrolizumab Pembrolizumab | A Phase II Study of Neoadjuvant Pembrolizumab & Lenvatinib for Resectable Stage III Melanoma (Neo PeLe) | Active, not recruiting | AUS | 0 |
| NCT04427293 | Phase I | Lenvatinib + Pembrolizumab | Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC) | 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 | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 12 |
| NCT04729348 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab And Lenvatinib In Leptomeningeal Metastases | Terminated | USA | 0 |
| NCT05101629 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab Therapy | Active, not recruiting | DEU | 0 |
| NCT05147558 | Phase II | Lenvatinib + Pembrolizumab | A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma | Recruiting | USA | 0 |
| NCT05319015 | Phase II | Lenvatinib + Pembrolizumab | Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus | 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 10 |
| NCT05041153 | Phase I | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma | 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 | Completed | 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 11 |
| NCT05263492 | Phase II | Lenvatinib + Pembrolizumab | Study of Lenvatinib w/ Pembro in Black Participants w/Mismatch Repair-Prof Recurrent Endometrial Cancer | Recruiting | USA | 0 |
| 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | CAN | AUS | 7 |
| 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 9 |
| NCT02973997 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib in Treating Metastatic or Recurrent Differentiated Thyroid Cancer That Cannot Be Removed by Surgery | Completed | 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 |
| NCT05433116 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC | Recruiting | DEU | 0 |
| NCT05273554 | Phase I | Lenvatinib + Pembrolizumab | A Pilot Study to Assess Changes in Tumor Biology Following Second-line Treatment With Pembrolizumab Plus Lenvatinib in Patients With Advanced Pancreatic Ductal Adenocarcinoma | Recruiting | USA | 0 |
| NCT04887805 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer | Recruiting | USA | 0 |
| NCT05185739 | Phase II | Lenvatinib + Pembrolizumab Lenvatinib Pembrolizumab | Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC) (PRIMER-1) | Recruiting | GBR | 0 |
| NCT05296512 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer | Recruiting | USA | 0 |
| NCT04626479 | Phase Ib/II | Lenvatinib + MK-1308A Lenvatinib + MK-4280A Lenvatinib + Pembrolizumab Belzutifan + Lenvatinib + Pembrolizumab | Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A) | Active, not recruiting | USA | NZL | NLD | GBR | FRA | ESP | CAN | AUS | 6 |
| NCT06266338 | Phase II | Lenvatinib + Pembrolizumab | Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix) | Recruiting | USA | 0 |
| 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 9 |
| NCT04865887 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib in Advanced Cervical Cancer | Recruiting | USA | 0 |
| NCT04710628 | Phase II | Lenvatinib + Pembrolizumab | Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents (PECATI) | Active, not recruiting | ITA | FRA | ESP | 0 |
| NCT05603910 | Phase I | Lenvatinib + Pembrolizumab | Phase 1 Clinical Trial of Lenvatinib, Pembrolizumab and Hypofractionated Pelvic Radiation Therapy for pMMR Recurrent/Unresectable Endometrial Carcinoma | Recruiting | USA | 0 |
| NCT05114421 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib for the Treatment of Serous Ovarian Cancer Patients | 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 | GBR | FRA | ESP | CAN | AUS | 9 |
| NCT05746208 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib Plus Pembrolizumab in Well Differentiated G3 Neuroendocrine Tumors | Recruiting | USA | 0 |
| NCT04955743 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab and Lenvatinib in Patients With Brain Metastases From Melanoma or Renal Cell Carcinoma | Recruiting | USA | 0 |
| NCT05733715 | Phase I | Pembrolizumab Lenvatinib + Pembrolizumab | Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma | Recruiting | USA | 0 |
| NCT04287829 | Phase II | Lenvatinib + Pembrolizumab | Pembrolizumab Plus Lenvatinib In Second Line and Third Line Malignant Pleural mesotheLioma Patients (PEMMELA) | Recruiting | NLD | 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) | Active, not recruiting | USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | AUS | 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 | NZL | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 12 |
| 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 |
| 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) | Completed | USA | ESP | CAN | AUS | 1 |
| NCT05327686 | Phase II | Axitinib + Pembrolizumab Lenvatinib + Pembrolizumab Ipilimumab + Nivolumab Avelumab + Axitinib Cabozantinib + Nivolumab | Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Study (SAMURAI) | Recruiting | USA | 0 |
| NCT04784247 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib and Pembrolizumab in People With Advanced Soft Tissue Sarcoma | 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) | Active, not recruiting | USA | 0 |
| 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) | Active, not recruiting | USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 11 |
| NCT05308901 | Phase II | Lenvatinib + Pembrolizumab | Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Naive Metastatic Uveal Melanoma | Recruiting | USA | 0 |
| NCT04736706 | Phase III | Lenvatinib + Pembrolizumab Lenvatinib + MK-1308A Belzutifan + Lenvatinib + Pembrolizumab | 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) | Active, not recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS | 27 |
| NCT05545969 | Phase II | Lenvatinib + Pembrolizumab | Neoadjuvant Pembrolizumab and Lenvatinib for Mucosal Melanoma (Neo PeLeMM) | Not yet recruiting | AUS | 0 |
| NCT04869137 | Phase II | Lenvatinib + Pembrolizumab | Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma | 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-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007) | Active, not recruiting | USA | ITA | FRA | CAN | AUS | 14 |
| 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 | Recruiting | USA | 0 |
| NCT06364631 | Phase III | Cabozantinib + Nivolumab Ipilimumab + Nivolumab Axitinib + Pembrolizumab Lenvatinib + Pembrolizumab | CARE1 Pragmatic Clinical Trial (CARE1) | Recruiting | FRA | 0 |
| 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) | Active, not recruiting | USA | GBR | ESP | DEU | CAN | AUS | 9 |
| NCT05282901 | Phase II | Lenvatinib + Pembrolizumab | Efficacy and Safety of Pembrolizumab in Combination With Lenvatinib in Metastatic Uveal MElanoma Patients (PLUME) (PLUME) | Recruiting | FRA | 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) | Active, not recruiting | USA | ITA | GBR | ESP | CAN | AUS | 10 |
| 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 9 |
| NCT06036836 | Phase II | Lenvatinib + Pembrolizumab Lenvatinib + MK-4280A MK-4280A Pembrolizumab | Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010) | Recruiting | USA | NLD | CAN | AUS | 3 |
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