Trial intelligence / Profile preview

TAR-200 with or without cetrelimab versus intravesical BCG in BCG-naive high-risk non-muscle invasive bladder cancer

NL-OMON59935Phase 3Active, not recruiting

Sponsor
Janssen Pharmaceutical
Start
Oct 2023
Modality
Small Molecules, Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Countries
1
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Overview

Phase 3, randomised, open-label trial in non-muscle-invasive bladder cancer (NMIBC) comparing TAR-200 + cetrelimab, Intravesical BCG and TAR-200 alone (3 arms). Primary endpoint: Event-free survival. Started Oct 2023; status: active, not recruiting.

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Drugs

gemcitabine-releasing intravesical systemcetrelimabbcg vaccinegemcitabine
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Conditions

non-muscle-invasive bladder cancer (NMIBC)

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