Study of MEDI4736 (Durvalumab) with or without Tremelimumab versus Standard of Care Chemotherapy in Urothelial Cancer

Study identifier:D419BC00001

ClinicalTrials.gov identifier:NCT02516241

EudraCT identifier:2015-001633-24

CTIS identifier:N/A

Recruitment Complete

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

Medical condition

Urothelial Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

MEDI4736 (Durvalumab), Tremelimumab, Cisplatin, Carboplatin, Gemcitabine

Sex

All

Actual Enrollment

1126

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 02 Nov 2015
Primary Completion Date: 27 Jan 2020
Estimated Study Completion Date: 30 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria