{"preliminary_commentary":{"by_channel":{"youtube":20,"x_thread":19,"podcast":11},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03711032\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["pembrolizumab"]],"indication":"high-risk non-muscle invasive bladder cancer","name":"KEYNOTE-676","nct_id":"NCT03711032","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-676-nct03711032. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants receive BCG (Induction and Maintenance) in combination with 200 mg pembrolizumab administered intravenously (IV) every 3 weeks (Q3W) for 35 doses (\\~2 years).","label":"BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)","type":"EXPERIMENTAL"},{"description":"Participants receive BCG monotherapy (Induction and Maintenance).","label":"BCG Monotherapy: Post-induction Cohort A (Arm A-2)","type":"EXPERIMENTAL"},{"description":"Participants receive BCG (Induction and reduced Maintenance) in combination with 400 mg pembrolizumab administered IV every 6 weeks (Q6W) for 9 doses (\\~1 year).","label":"BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)","type":"EXPERIMENTAL"},{"description":"Participants receive BCG (Induction and full Maintenance) in combination with 400 mg pembrolizumab administered IV Q6W for 9 doses (\\~1 year).","label":"BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)","type":"EXPERIMENTAL"},{"description":"Participants receive BCG monotherapy (Induction and Maintenance).","label":"BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2034-11-20","type":"ESTIMATED"},"conditions":["High-risk Non-muscle Invasive Bladder Cancer"],"enrollment":{"count":1397,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Pembrolizumab","otherNames":["KEYTRUDA®","MK-3475"],"type":"BIOLOGICAL"},{"name":"BCG","otherNames":["TICE® BCG","OncoTICE®"],"type":"BIOLOGICAL"}],"last_update":"2026-10-23","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"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)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2028-07-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)","timeFrame":"Up to ~3.5 years"},{"measure":"Event-Free Survival (EFS) (Cohort B)","timeFrame":"Up to ~5 years"}],"references":[{"citation":"Kamat AM, Shore N, Hahn N, Alanee S, Nishiyama H, Shariat S, Nam K, Kapadia E, Frenkl T, Steinberg G. KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. Future Oncol. 2020 Apr;16(10):507-516. doi: 10.2217/fon-2019-0817. Epub 2020 Mar 12.","pmid":"32162533","type":"DERIVED"}],"start_date":{"date":"2018-12-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"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)","url":"https://clinicaltrials.gov/study/NCT03711032"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-676-nct03711032"}