{"entity":{"id":"nct02516241","kind":"trial","name":"Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer","aka":[],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab, Cisplatin, Carboplatin and Gemcitabine in bladder & urothelial cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer is a phase 3 interventional study registered as NCT02516241 by AstraZeneca, with 1126 participants enrolled, started 2015-11-02 and due to reach its primary completion in 2020-01-27. Interventions recorded: MEDI4736 (Durvalumab), Tremelimumab, Cisplatin, Carboplatin and Gemcitabine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02516241","url":"https://clinicaltrials.gov/study/NCT02516241"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["urothelial","muscle-invasive-bladder-cancer"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","cisplatin","carboplatin","gemcitabine"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02516241","phase":"3","setting":"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","sponsor":"AstraZeneca","started":"2015-11-02","startedType":"actual","yearReported":2021,"enrolled":1126,"enrolledBasis":"registry","outcomes":[{"endpoint":"To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set","primary":true,"unit":"months","arms":[{"name":"Combination Therapy","n":342,"value":15.1,"note":"95% CI 13.1 to 18.0; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication"},{"name":"Standard of Care","n":344,"value":12.1,"note":"95% CI 10.9 to 14"}],"hr":0.85,"p":"0.0751","source":"https://clinicaltrials.gov/study/NCT02516241?tab=results"},{"endpoint":"To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set","primary":true,"unit":"months","arms":[{"name":"Monotherapy","n":209,"value":14.4,"note":"95% CI 10.4 to 17.3; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication"},{"name":"Standard of Care","n":207,"value":12.1,"note":"95% CI 10.4 to 15.0"}],"hr":0.89,"p":"0.3039","source":"https://clinicaltrials.gov/study/NCT02516241?tab=results"},{"endpoint":"PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","unit":"months","arms":[{"name":"Combination Therapy","n":342,"value":3.7,"note":"95% CI 3.4 to 3.8; Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication"},{"name":"Monotherapy","n":346,"value":2.3,"note":"95% CI 1.9 to 3.5"},{"name":"Standard of Care","n":344,"value":6.7,"note":"95% CI 5.7 to 7.3"}],"source":"https://clinicaltrials.gov/study/NCT02516241?tab=results"},{"endpoint":"Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC","unit":"%","arms":[{"name":"Combination Therapy","n":342,"value":36.3,"note":"Figures from the ClinicalTrials.gov results section (first posted 2021-05-13), not from a publication"},{"name":"Monotherapy","n":346,"value":25.7},{"name":"Standard of Care","n":344,"value":49.1}],"source":"https://clinicaltrials.gov/study/NCT02516241?tab=results"}]},"route":"/trials/nct02516241/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"tremelimumab","kind":"drug","name":"Tremelimumab","route":"/drugs/tremelimumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}