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Phase 3 study of TAR-200 with or without cetrelimab versus intravesical BCG in BCG-naive high-risk non-muscle invasive bladder cancer
2023-507187-39-00Phase 3Authorised
- Sponsor
- Janssen Pharmaceutical
- Start
- Mar 2023
- Modality
- Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules, Vaccines & Immunotherapeutics
- Countries
- 21
01
Overview
Phase 3, randomised, open-label trial in non-muscle-invasive bladder cancer (NMIBC) comparing TAR-200 + cetrelimab, TAR-200 monotherapy and Intravesical BCG (3 arms). Primary endpoints: Event-free survival and Progression definition within event-free survival. Planned start Mar 2023; status: authorised.
02
Drugs
gemcitabine-releasing intravesical systemcetrelimabbcg vaccine
03
Conditions
non-muscle-invasive bladder cancer (NMIBC)
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