{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":false},"commentary_summary":null,"drugs_tested":[["nivolumab"],["nivolumab","BCG"],["nivolumab","linrodostat (BMS-986205)"]],"indication":"BCG-unresponsive high-risk non-muscle invasive bladder cancer","name":"CheckMate 9UT","nct_id":"NCT03519256","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=checkmate-9ut-nct03519256. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"CheckMate 9UT","arms":[{"description":null,"label":"Nivolumab monotherapy","type":"EXPERIMENTAL"},{"description":null,"label":"Nivolumab + BCG","type":"EXPERIMENTAL"},{"description":null,"label":"Nivolumab + BMS-986205","type":"EXPERIMENTAL"},{"description":null,"label":"Nivolumab + BMS-986205 + BCG","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2022-08-24","type":"ACTUAL"},"conditions":["Urinary Bladder Neoplasms"],"enrollment":{"count":142,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nivolumab","otherNames":["Opdivo","BMS-936558"],"type":"BIOLOGICAL"},{"name":"BCG","otherNames":["Bacillus Calumette-Guerin"],"type":"BIOLOGICAL"},{"name":"BMS-986205","otherNames":[],"type":"DRUG"}],"last_update":"2023-06-01","lead_sponsor":"Bristol-Myers Squibb","official_title":"A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined With Intravesical BCG in Participants With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-08-22","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Adverse Events (AEs)","timeFrame":"From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"},{"measure":"Number of Participants With Serious Adverse Events (SAEs)","timeFrame":"From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"},{"measure":"Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Study Treatment","timeFrame":"From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"},{"measure":"Number of Participants Immune-Mediated Adverse Events (IMAEs)","timeFrame":"From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"},{"measure":"Number of Participants Who Died","timeFrame":"From first dose to 100 days post last dose of study treatment (an average of 45 weeks up to approximately 74 weeks)"},{"measure":"Number of Participants With Specific Liver Laboratory Abnormalities","timeFrame":"From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"},{"measure":"Number of Participants With Specific Thyroid Laboratory Abnormalities","timeFrame":"From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"},{"measure":"Number of Participants With Changes From Baseline Laboratory Values","timeFrame":"From baseline to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"},{"measure":"Number of Participants With Adverse Events (AEs) by Anti-Drug- Antibody (ADA) Status","timeFrame":"From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"},{"measure":"Number of Participants With Serious Adverse Events (SAEs) by Anti-Drug- Antibody (ADA) Status","timeFrame":"From first dose to 30 days post last dose of study treatment (an average of 45 weeks up to approximately 64 weeks)"}],"references":[],"start_date":{"date":"2018-08-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder","url":"https://clinicaltrials.gov/study/NCT03519256"},"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/checkmate-9ut-nct03519256"}