{"preliminary_commentary":{"by_channel":{"x_thread":6},"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":null,"indication":null,"name":"NCT02812420","nct_id":"NCT02812420","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02812420. 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":"Patients receive tremelimumab IV over 1 hour and durvalumab IV over 1 hour on day 1 of weeks 1 and 4. Beginning 4-6 weeks after the last infusion, patients undergo cystectomy with pelvic lymph node dissection surgery.","label":"Treatment (tremelimumab, durvalumab)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2027-12-31","type":"ESTIMATED"},"conditions":["Hydronephrosis","Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant","Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant","Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant","Infiltrating Renal Pelvis Urothelial Carcinoma, Sarcomatoid Variant","Renal Pelvis Urothelial Carcinoma","Stage II Bladder Urothelial Carcinoma AJCC v6 and v7","Stage II Renal Pelvis Cancer AJCC v7","Stage II Ureter Cancer AJCC v7","Stage II Urethral Cancer AJCC v7","Stage III Bladder Urothelial Carcinoma AJCC v6 and v7","Stage III Renal Pelvis Cancer AJCC v7","Stage III Ureter Cancer AJCC v7","Stage III Urethral Cancer AJCC v7","Stage IV Renal Pelvis Cancer AJCC v7","Stage IV Ureter Cancer AJCC v7","Stage IV Urethral Cancer AJCC v7","Ureter Urothelial Carcinoma","Urethral Urothelial Carcinoma"],"enrollment":{"count":54,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Durvalumab","otherNames":["Imfinzi","Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer","MEDI-4736","MEDI4736"],"type":"BIOLOGICAL"},{"name":"Therapeutic Conventional Surgery","otherNames":[],"type":"PROCEDURE"},{"name":"Tremelimumab","otherNames":["Anti-CTLA4 Human Monoclonal Antibody CP-675,206","CP-675","CP-675,206","CP-675206","Ticilimumab"],"type":"BIOLOGICAL"}],"last_update":"2026-09-14","lead_sponsor":"M.D. Anderson Cancer Center","official_title":"A Pilot Pre-Surgical Study Evaluating Anti-PD-L1 Antibody (Durvalumab) Plus Anti-CTLA-4 (Tremelimumab) in Patients With Muscle-Invasive, High-Risk Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Neoadjuvant Chemotherapy","overall_status":"ACTIVE_NOT_RECRUITING","phases":["EARLY_PHASE1"],"primary_completion_date":{"date":"2027-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Incidence of adverse events determined by extreme toxicity","timeFrame":"Up to 90 days after last dose of treatment"}],"references":[{"citation":"Gao J, Navai N, Alhalabi O, Siefker-Radtke A, Campbell MT, Tidwell RS, Guo CC, Kamat AM, Matin SF, Araujo JC, Shah AY, Msaouel P, Corn P, Wang J, Papadopoulos JN, Yadav SS, Blando JM, Duan F, Basu S, Liu W, Shen Y, Zhang Y, Macaluso MD, Wang Y, Chen J, Zhang J, Futreal A, Dinney C, Allison JP, Goswami S, Sharma P. Neoadjuvant PD-L1 plus CTLA-4 blockade in patients with cisplatin-ineligible operable high-risk urothelial carcinoma. Nat Med. 2020 Dec;26(12):1845-1851. doi: 10.1038/s41591-020-1086-y. Epub 2020 Oct 12.","pmid":"33046869","type":"DERIVED"}],"start_date":{"date":"2017-03-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Durvalumab and Tremelimumab in Treating Patients With Muscle-Invasive, High-Risk Urothelial Cancer That Cannot Be Treated With Cisplatin-Based Therapy Before Surgery","url":"https://clinicaltrials.gov/study/NCT02812420"},"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/nct02812420"}