BCG in combination with durvalumab in adult BCG-naïve, high-risk NMIBC participants - PATAPSCO

Study identifier:D419JC00002

ClinicalTrials.gov identifier:NCT05943106

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase IIIb Open-Label, Single-Arm, Multi-Center, US Study of Bacillus Calmette-Guerin (BCG) Administered in Combination with Durvalumab in Adult BCG-naïve, High-risk Non–Muscle- Invasive Bladder Cancer Participants (PATAPSCO)

Medical condition

Non–Muscle- Invasive Bladder Cancer

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Estimated Enrollment

100

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 11 Aug 2023
Estimated Primary Completion Date: 30 Sept 2025
Estimated Study Completion Date: 30 May 2027

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria