Trial intelligence / Profile preview

Phase 2b study of TAR-200 with or without cetrelimab in BCG-unresponsive high-risk non-muscle-invasive bladder cancer

NL-OMON60682Phase 2Active, not recruiting

Sponsor
Janssen Pharmaceutical
Start
Nov 2025
Modality
Small Molecules, Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics
Countries
1
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Overview

Phase 2, randomised, open-label trial of gemcitabine-releasing intravesical system, cetrelimab and gemcitabine in transitional cell carcinoma of the bladder (TCC) and Bladder cancer in situ (CIS) (4 cohorts), sponsored by Janssen Pharmaceutical. Primary endpoints: Overall complete response rate and Disease-free survival. Started Nov 2025; status: active, not recruiting.

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Drugs

gemcitabine-releasing intravesical systemcetrelimabgemcitabine
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Conditions

transitional cell carcinoma of the bladder (TCC)Bladder cancer in situ (CIS)

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