{"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":[["durvalumab","tremelimumab"],["durvalumab"]],"indication":"previously untreated unresectable stage IV urothelial carcinoma","name":"NCT02516241","nct_id":"NCT02516241","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02516241. 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":"MEDI4736 (Durvalumab) + Tremelimumab","label":"Combination Therapy","type":"EXPERIMENTAL"},{"description":"MEDI4736 (Durvalumab)","label":"Monotherapy","type":"EXPERIMENTAL"},{"description":"Standard of Care Chemotherapy Treatment","label":"Standard of Care","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"conditions":["Urothelial Cancer"],"enrollment":{"count":1126,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"MEDI4736 (Durvalumab)","otherNames":[],"type":"DRUG"},{"name":"Tremelimumab","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"}],"last_update":"2026-07-14","lead_sponsor":"AstraZeneca","official_title":"A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2020-01-27","type":"ACTUAL"},"primary_outcomes":[{"measure":"To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set","timeFrame":"From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years)."},{"measure":"To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set","timeFrame":"From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years)."}],"references":[{"citation":"Powles T, van der Heijden MS, Castellano D, Galsky MD, Loriot Y, Petrylak DP, Ogawa O, Park SH, Lee JL, De Giorgi U, Bogemann M, Bamias A, Eigl BJ, Gurney H, Mukherjee SD, Fradet Y, Skoneczna I, Tsiatas M, Novikov A, Suarez C, Fay AP, Duran I, Necchi A, Wildsmith S, He P, Angra N, Gupta AK, Levin W, Bellmunt J; DANUBE study investigators. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1574-1588. doi: 10.1016/S1470-2045(20)30541-6. Epub 2020 Sep 21.","pmid":"32971005","type":"DERIVED"}],"start_date":{"date":"2015-11-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer","url":"https://clinicaltrials.gov/study/NCT02516241"},"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/nct02516241"}