{"entity":{"id":"nct03711032","kind":"trial","name":"Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)","aka":["KEYNOTE-676"],"tldr":"A phase 3 trial of Pembrolizumab in bladder & urothelial cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.","summary":"Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676) is a phase 3 interventional study registered as NCT03711032 by Merck Sharp & Dohme LLC, with 1397 participants enrolled, started 2018-12-24 and due to reach its primary completion in 2026-07-31. Interventions recorded: Pembrolizumab and BCG.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03711032","url":"https://clinicaltrials.gov/study/NCT03711032"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["pembrolizumab"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03711032","phase":"3","setting":"A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)","sponsor":"Merck Sharp & Dohme LLC","participation":[{"nct":"NCT03711032","source":"https://clinicaltrials.gov/study/NCT03711032","fetchedAt":"2026-10-07T16:53:07.266Z","studySha256":"8b38d1c30b6d4c56bb1f9f7ab301564a10efbe437996d10412bdf16ce458df8c","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-05-01","leadSponsor":"Merck Sharp & Dohme LLC","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":1397,"enrolmentType":"ESTIMATED","siteCount":209,"recruitingSiteCount":0,"countries":["Australia","Austria","Belgium","Brazil","Canada","China","Colombia","Costa Rica","Finland","France","Germany","Greece","Guatemala","Hungary","Italy","Japan","Malaysia","Netherlands","Norway","Peru","Poland","Portugal","Puerto Rico","South Korea","Spain","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2018-12-24","startedType":"actual","enrolled":1397,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct03711032/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","route":"/cancers/non-muscle-invasive-bladder-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}]}}