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

Summary

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 Stage IV Urothelial Cancer

Timeline

Start

2015-11-02

Primary completion

2020-01-27

Completion

2026-12-31

Outcome

Missed primary endpoint

paper This study did not meet either of its coprimary endpoints. PMID 32971005 ↗

registry analysis (superiority test); Combination Therapy vs Standard of Care; p = 0.0751 NCT02516241 ↗

registry analysis (superiority test); Monotherapy vs Standard of Care; p = 0.3039 NCT02516241 ↗

release “The Phase III DANUBE trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints” astrazeneca.com ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	—	Intravenous
Comparator	Cisplatin	Other / unclassified	—	Intravenous
Subject	Durvalumab	Monoclonal antibody	1500 mg	Intravenous
Comparator	Gemcitabine	Small molecule	—	Intravenous
Subject	Tremelimumab	Monoclonal antibody	75 mg	Intravenous

Indications