# Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer

Source: https://onco.cc/trials/nct02516241/  
OnCo record `nct02516241` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: 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
- Enrolled: 1126
- Outcomes: To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set: Combination Therapy 15.1 months vs Standard of Care 12.1 months, HR 0.85; To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set: Monotherapy 14.4 months vs Standard of Care 12.1 months, HR 0.89; PFS, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC: Combination Therapy 3.7 months vs Monotherapy 2.3 months vs Standard of Care 6.7 months; Objective Response Rate (ORR), Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC: Combination Therapy 36.3% vs Monotherapy 25.7% vs Standard of Care 49.1%

## Sources

- ClinicalTrials.gov NCT02516241: https://clinicaltrials.gov/study/NCT02516241

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Muscle-invasive and advanced bladder cancer](https://onco.cc/cancers/muscle-invasive-bladder-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Durvalumab](https://onco.cc/drugs/durvalumab/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Tremelimumab](https://onco.cc/drugs/tremelimumab/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)

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