{"id":"placebo-for-lenvatinib","safety":{"commonSideEffects":[]},"_chembl":null,"_fixedAt":"2026-03-30T12:16:20.314321","_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Placebos are inert substances used as controls in clinical trials to establish the efficacy of an active drug by comparison. Any observed effects in placebo groups are attributed to natural disease progression, regression to the mean, or the placebo effect (psychological/expectation-based response). In this Phase 3 trial, the placebo serves as the control arm against which lenvatinib's therapeutic benefit is measured.","oneSentence":"A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:27:13.303Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Control arm in Phase 3 clinical trial for lenvatinib"}]},"_fixedFields":["modality→Small Molecule"],"trialDetails":[{"nctId":"NCT04199104","phase":"PHASE3","title":"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) (MK-7902-010) (KEYNOTE-010)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-02-05","conditions":"Head and Neck Squamous Cell Carcinoma","enrollment":511},{"nctId":"NCT05523323","phase":"PHASE3","title":"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) (MK-7902-010/LEAP-010)-China Extension","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-10-30","conditions":"Head and Neck Squamous Cell Carcinoma","enrollment":112},{"nctId":"NCT03829332","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-03-13","conditions":"Non-small Cell Lung Cancer","enrollment":623},{"nctId":"NCT03820986","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-03-12","conditions":"Malignant Melanoma","enrollment":674},{"nctId":"NCT03713593","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-12-31","conditions":"Carcinoma, Hepatocellular","enrollment":794},{"nctId":"NCT03898180","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-05-06","conditions":"Urothelial Carcinoma","enrollment":505},{"nctId":"NCT03829319","phase":"PHASE3","title":"Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-03-25","conditions":"Nonsquamous Non-small Cell Lung Cancer","enrollment":761},{"nctId":"NCT07383441","phase":"PHASE3","title":"Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer","status":"NOT_YET_RECRUITING","sponsor":"SWOG Cancer Research Network","startDate":"2026-06-10","conditions":"Advanced Clear Cell Renal Cell Carcinoma, Metastatic Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8","enrollment":718},{"nctId":"NCT04889118","phase":"PHASE3","title":"Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advanced Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)-China Extension Study","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-07-14","conditions":"Malignant Melanoma","enrollment":131},{"nctId":"NCT04246177","phase":"PHASE3","title":"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)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2020-05-22","conditions":"Carcinoma, Hepatocellular","enrollment":480},{"nctId":"NCT04523493","phase":"PHASE3","title":"Phase III Study of Toripalimab（JS001） Combined With Lenvatinib for Advanced HCC","status":"ACTIVE_NOT_RECRUITING","sponsor":"Shanghai Junshi Bioscience Co., Ltd.","startDate":"2020-06-29","conditions":"Advanced Hepatocellular Carcinoma (HCC)","enrollment":530},{"nctId":"NCT04716933","phase":"PHASE3","title":"Safety and Efficacy Study of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-7902-006/E7080-G000-315/LEAP-006)-China Extension Study","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-11-05","conditions":"Nonsquamous Non-small Cell Lung Cancer","enrollment":201},{"nctId":"NCT05342194","phase":"PHASE3","title":"Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study","status":"RECRUITING","sponsor":"Shanghai Junshi Bioscience Co., Ltd.","startDate":"2023-06-19","conditions":"Intrahepatic Cholangiocarcinoma","enrollment":480},{"nctId":"NCT04676412","phase":"PHASE3","title":"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] - China Extension Study","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-10-23","conditions":"Non-small Cell Lung Cancer","enrollment":107},{"nctId":"NCT06371157","phase":"PHASE3","title":"A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma","status":"RECRUITING","sponsor":"Akeso","startDate":"2024-08-02","conditions":"Hepatocellular Carcinoma","enrollment":469},{"nctId":"NCT03477175","phase":"PHASE2","title":"Study to Assess the Long-term Safety of Lenvatinib Monotherapy, a Lenvatinib Combination Regimen, or a Comparator Treatment Arm to Cancer Participants in Eisai Sponsored Lenvatinib Trials","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2018-08-16","conditions":"Solid Tumors","enrollment":40},{"nctId":"NCT06563934","phase":"PHASE2","title":"Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)","status":"NOT_YET_RECRUITING","sponsor":"Xu Yong, MD","startDate":"2024-08-30","conditions":"Liver Cancer","enrollment":70},{"nctId":"NCT04193553","phase":"PHASE2","title":"Multicentre Placebo-controlled Double-blinded Phase II Study of Lenvatinib Efficacy in Patients With Locally Advanced or Metastatic GIST (Gastrointestinal Stromal Tumor) After Imatinib/Sunitinib Failure","status":"COMPLETED","sponsor":"Centre Leon Berard","startDate":"2020-01-17","conditions":"Gastro Intestinal Stromal Tumour","enrollment":77},{"nctId":"NCT01321554","phase":"PHASE3","title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2011-03-17","conditions":"Thyroid Cancer","enrollment":392},{"nctId":"NCT02966093","phase":"PHASE3","title":"A Trial of Lenvatinib (E7080) in Radioiodine (131 I)-Refractory Differentiated Thyroid Cancer in China","status":"COMPLETED","sponsor":"Eisai Co., Ltd.","startDate":"2017-01-11","conditions":"Differentiated Thyroid Cancer (DTC)","enrollment":151},{"nctId":"NCT03744247","phase":"PHASE3","title":"Lenvatinib Plus PD-1 Antibody Versus Lenvtinib Alone for Advanced HCC","status":"WITHDRAWN","sponsor":"Sun Yat-sen University","startDate":"2019-04-21","conditions":"Hepatocellular Carcinoma","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":116,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Placebo for lenvatinib","genericName":"Placebo for lenvatinib","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect. Used for Control arm in Phase 3 clinical trial for lenvatinib.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":5,"withResults":5},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}