{"preliminary_commentary":{"by_channel":{"x_thread":4},"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":[["bempegaldesleukin","nivolumab"],["nivolumab"]],"indication":"cisplatin-ineligible muscle-invasive bladder cancer","name":"NCT04209114","nct_id":"NCT04209114","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04209114. 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":null,"arms":[{"description":"Neoadjuvant (pre-surgical treatment) nivolumab + bempeg, followed by radical cystectomy (RC), followed by adjuvant (post-surgical treatment) nivolumab + bempeg","label":"Arm A: Combination Therapy","type":"EXPERIMENTAL"},{"description":"Neoadjuvant nivolumab, followed by RC, followed by adjuvant nivolumab","label":"Arm B: Monotherapy","type":"EXPERIMENTAL"},{"description":"RC alone, without neoadjuvant or adjuvant therapy","label":"Arm C: Standard-of-care","type":"OTHER"}],"collaborators":["Nektar Therapeutics"],"completion_date":{"date":"2023-06-07","type":"ACTUAL"},"conditions":["Bladder Cancer","Bladder Tumor","Muscle-Invasive Bladder Cancer"],"enrollment":{"count":114,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nivolumab","otherNames":["Opdivo","BMS-936558"],"type":"BIOLOGICAL"},{"name":"Radical cystectomy (RC)","otherNames":[],"type":"PROCEDURE"},{"name":"Bempegaldesleukin","otherNames":["BMS-986321","NKTR-214","Bempeg"],"type":"BIOLOGICAL"}],"last_update":"2024-06-27","lead_sponsor":"Bristol-Myers Squibb","official_title":"A Phase 3, Randomized, Study of Neoadjuvant and Adjuvant Nivolumab Plus Bempegaldesleukin (NKTR-214), Versus Nivolumab Alone Versus Standard of Care in Participants With Muscle-Invasive Bladder Cancer (MIBC) Who Are Cisplatin Ineligible","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2023-06-07","type":"ACTUAL"},"primary_outcomes":[{"measure":"Pathologic Complete Response (pCR) Rate- Nivolumab + Bempegaldesleukin Compared to Standard of Care","timeFrame":"From time of radical cystectomy up to 100 days after last treatment (up to approximately 17 months)"},{"measure":"Event Free Survival (EFS) - Nivolumab + Bempegaldesleukin Compared to Standard of Care","timeFrame":"From randomization up to first EFS event (up to approximately 30 months)"}],"references":[],"start_date":{"date":"2020-02-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer","url":"https://clinicaltrials.gov/study/NCT04209114"},"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/nct04209114"}