Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC - NIAGARA

Study identifier:D933RC00001

ClinicalTrials.gov identifier:NCT03732677

EudraCT identifier:2018-001811-59

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer.

Medical condition

Muscle invasive bladder cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab, Cisplatin, Gemcitabine

Sex

All

Actual Enrollment

1063

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 16 Nov 2018
Estimated Primary Completion Date: 30 Jun 2025
Estimated Study Completion Date: 30 Jun 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria