drugset / Trial / NCT05714202

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

NCT05714202

Phase 3 Active not recruiting 1135 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Timeline

Start
2023-03-23
Primary completion
2029-09-18
Completion
2029-09-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bacillus Calmette-Guerin Unknown Other
Subject Cetrelimab Monoclonal antibody
Subject TAR-200 Other / unclassified Other