Assessment of efficacy and safety of Durvalumab plus BCG compared to the standard therapy with BCG in non-muscle invasive bladder cancer - POTOMAC

Study identifier:D419JC00001

ClinicalTrials.gov identifier:NCT03528694

EudraCT identifier:2017-002979-26

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients

Medical condition

Non-muscle-invasive bladder cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

1018

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 14 May 2018
Estimated Primary Completion Date: 31 Oct 2024
Estimated Study Completion Date: 30 Sept 2025

Study design

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

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria