{"id":"placebo-for-nivolumab","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL2108738","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Placebo is an inert substance used as a control in clinical trials to establish the efficacy of an active drug by comparison. In this context, it serves as the control arm in Phase 3 trials of Nivolumab (a PD-1 inhibitor). Any observed effects in the placebo group are attributable to the placebo effect, natural disease progression, or other non-pharmacological factors.","oneSentence":"A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:27:13.033Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Control arm in Phase 3 clinical trials of Nivolumab"}]},"trialDetails":[{"nctId":"NCT05111574","phase":"PHASE2","title":"Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2022-08-11","conditions":"Anal Melanoma, Bladder Melanoma, Cervical Melanoma","enrollment":101},{"nctId":"NCT02194738","phase":"NA","title":"Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2014-09-26","conditions":"Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Cancer AJCC v8","enrollment":8300},{"nctId":"NCT07174947","phase":"PHASE2","title":"SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety","status":"RECRUITING","sponsor":"First Affiliated Hospital of Wenzhou Medical University","startDate":"2025-10-01","conditions":"Hepatobiliary Malignancy, Fluoxetine, Anxiety Disorders","enrollment":240},{"nctId":"NCT07246863","phase":"PHASE2","title":"Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC","status":"RECRUITING","sponsor":"CatalYm GmbH","startDate":"2025-10-07","conditions":"Metastatic Non-Squamous Non-Small Cell Lung Cancer, Adult Solid Tumor","enrollment":131},{"nctId":"NCT06561087","phase":"PHASE2","title":"Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2025-02-27","conditions":"Premalignant Lesion","enrollment":45},{"nctId":"NCT04606316","phase":"PHASE1","title":"Surgical Nivolumab And Ipilimumab For Recurrent GBM","status":"ACTIVE_NOT_RECRUITING","sponsor":"Patrick Wen, MD","startDate":"2021-02-01","conditions":"Glioblastoma, GBM, Glioblastoma Multiforme","enrollment":63},{"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":"NCT03873402","phase":"PHASE3","title":"A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2019-06-21","conditions":"Renal Cell Carcinoma","enrollment":437},{"nctId":"NCT05034536","phase":"PHASE2","title":"PD-1 Antibody Therapy + Infliximab for Metastatic Melanoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2022-02-07","conditions":"Metastatic Melanoma","enrollment":36},{"nctId":"NCT05111626","phase":"PHASE3","title":"Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2022-03-14","conditions":"Gastric Cancer, Gastroesophageal Junction Adenocarcinoma","enrollment":515},{"nctId":"NCT06059547","phase":"PHASE2","title":"Neoadjuvant Immunotherapy Combined With the Anti-GDF-15 Antibody Visugromab to Treat Muscle Invasive Bladder Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"CatalYm GmbH","startDate":"2023-09-06","conditions":"Bladder Cancer, Adult Solid Tumor","enrollment":31},{"nctId":"NCT03383458","phase":"PHASE3","title":"A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2018-04-18","conditions":"Hepatocellular Carcinoma, Liver Cancer","enrollment":545},{"nctId":"NCT07219459","phase":"PHASE2","title":"Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI) Compared to Double Placebo and a TKI in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure","status":"NOT_YET_RECRUITING","sponsor":"CatalYm GmbH","startDate":"2026-02","conditions":"Unresectable or Metastatic Hepatocellular Carcinoma, Failure of First-Line Treatment That Included an Anti PD-(L)1 Compound, Child-Pugh A Hepatocellular Carcinoma","enrollment":104},{"nctId":"NCT04025879","phase":"PHASE3","title":"A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2019-11-05","conditions":"Carcinoma, Non-Small-Cell Lung","enrollment":461},{"nctId":"NCT04674683","phase":"PHASE3","title":"Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"HUYABIO International, LLC.","startDate":"2021-08-12","conditions":"Unresectable or Metastatic Melanoma, Progressive Brain Metastasis","enrollment":450},{"nctId":"NCT04988841","phase":"PHASE2","title":"Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2022-01-20","conditions":"Melanoma","enrollment":70},{"nctId":"NCT02667587","phase":"PHASE3","title":"An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2016-05-09","conditions":"Brain Neoplasms","enrollment":716},{"nctId":"NCT01844505","phase":"PHASE3","title":"Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2013-06-11","conditions":"Unresectable or Metastatic Melanoma","enrollment":945},{"nctId":"NCT02388906","phase":"PHASE3","title":"Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2015-03-16","conditions":"Melanoma","enrollment":906},{"nctId":"NCT03063450","phase":"PHASE3","title":"CheckpOiNt Blockade For Inhibition of Relapsed Mesothelioma","status":"COMPLETED","sponsor":"University of Southampton","startDate":"2017-03-28","conditions":"Mesothelioma","enrollment":332},{"nctId":"NCT02523313","phase":"PHASE2","title":"Immunotherapy With Nivolumab or Nivolumab Plus Ipilimumab vs. Double Placebo for Stage IV Melanoma w. NED","status":"COMPLETED","sponsor":"Prof. Dr. med. Dirk Schadendorf","startDate":"2015-09-02","conditions":"Malignant Melanoma","enrollment":167},{"nctId":"NCT05457959","phase":"PHASE1","title":"Peptide-Pulsed Dendritic Cell Vaccination in Combination With Nivolumab and Ipilimumab for the Treatment of Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-mutant","status":"WITHDRAWN","sponsor":"Jonsson Comprehensive Cancer Center","startDate":"2024-12-01","conditions":"Diffuse Hemispheric Glioma, H3 G34-Mutant","enrollment":""},{"nctId":"NCT04109066","phase":"PHASE3","title":"Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2019-11-18","conditions":"Breast Cancer","enrollment":521},{"nctId":"NCT06428422","phase":"NA","title":"The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients","status":"RECRUITING","sponsor":"Necmettin Erbakan University","startDate":"2024-08-12","conditions":"Metastatic Non-small Cell Lung Cancer","enrollment":100},{"nctId":"NCT03817125","phase":"PHASE1","title":"Melanoma Checkpoint and Gut Microbiome Alteration With Microbiome Intervention","status":"COMPLETED","sponsor":"Parker Institute for Cancer Immunotherapy","startDate":"2019-01-28","conditions":"Metastatic Melanoma","enrollment":14},{"nctId":"NCT03117049","phase":"PHASE3","title":"Study of ONO-4538 in Non-Squamous Non-Small Cell Lung Cancer (TASUKI-52)","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2017-06-13","conditions":"Non-Small Cell Lung Cancer","enrollment":550},{"nctId":"NCT02746796","phase":"PHASE2, PHASE3","title":"Study of ONO-4538 in Gastric Cancer","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2016-03","conditions":"Gastric Cancer","enrollment":680},{"nctId":"NCT03006705","phase":"PHASE3","title":"Study of Adjuvant ONO-4538 With Resected Gastric Cancer","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2017-01-31","conditions":"Gastric Cancer","enrollment":800},{"nctId":"NCT03685890","phase":"PHASE1, PHASE2","title":"Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion","status":"RECRUITING","sponsor":"Vastra Gotaland Region","startDate":"2019-04-01","conditions":"Melanoma, In-Transit Metastasis","enrollment":74},{"nctId":"NCT05005273","phase":"PHASE2","title":"A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2022-10-03","conditions":"Non-Small Cell Lung Cancer","enrollment":1},{"nctId":"NCT05887830","phase":"PHASE1, PHASE2","title":"Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial","status":"UNKNOWN","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2023-06-15","conditions":"Acute Anterior ST Segment Elevation Myocardial Infarction","enrollment":96},{"nctId":"NCT05834413","phase":"NA","title":"Clinical Study on the Prevention of Driver Gene Negative II-IIIa Lung Cancer Recurrence and Metastasis by Staged Chinese Herbal Medicine Combined With Chemotherapy and Immune Checkpoint Inhibitors","status":"NOT_YET_RECRUITING","sponsor":"Shanghai University of Traditional Chinese Medicine","startDate":"2023-05-01","conditions":"Lung Cancer","enrollment":367},{"nctId":"NCT03301636","phase":"PHASE2","title":"A Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab for Subjects With Unresectable or Metastatic Melanoma","status":"TERMINATED","sponsor":"NewLink Genetics Corporation","startDate":"2017-12-08","conditions":"Melanoma","enrollment":21},{"nctId":"NCT05213312","phase":"PHASE2, PHASE3","title":"Study of Neoadjuvant Nivolumab or Placebo Plus Chemotherapy Followed by Surgery and Adjuvant Treatment in Subjects With Resectable ESCC","status":"UNKNOWN","sponsor":"Shanghai Zhongshan Hospital","startDate":"2022-06-01","conditions":"Esophageal Squamous Cell Carcinoma","enrollment":90},{"nctId":"NCT01927419","phase":"PHASE2","title":"Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2013-08-23","conditions":"Unresectable Melanoma, Metastatic Melanoma","enrollment":142},{"nctId":"NCT02768558","phase":"PHASE3","title":"Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced NSCLC","status":"TERMINATED","sponsor":"RTOG Foundation, Inc.","startDate":"2016-10-17","conditions":"Non-Small Cell Lung Cancer","enrollment":20},{"nctId":"NCT03342352","phase":"PHASE3","title":"Nivolumab Plus Epacadostat in Combination With Chemotherapy Versus the EXTREME Regimen in Squamous Cell Carcinoma of the Head and Neck (CheckMate 9NA/ECHO-310)","status":"WITHDRAWN","sponsor":"Incyte Corporation","startDate":"2017-12-15","conditions":"Head and Neck Cancer","enrollment":""},{"nctId":"NCT03348904","phase":"PHASE3","title":"Nivolumab and Epacadostat With Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Non-Small Cell Lung Cancer","status":"TERMINATED","sponsor":"Incyte Corporation","startDate":"2017-12-27","conditions":"Lung Cancer","enrollment":2}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":209,"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 Nivolumab","genericName":"Placebo for Nivolumab","companyName":"Bristol-Myers Squibb","companyId":"bristol-myers-squibb","modality":"Biologic","firstApprovalDate":"","aiSummary":"A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect. Used for Control arm in Phase 3 clinical trials of Nivolumab.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}