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SunRISe-1 in BCG-unresponsive high-risk non-muscle-invasive bladder cancer
2023-506146-23-00Phase 2Authorised
- Sponsor
- Janssen Pharmaceutical
- Start
- May 2024
- Modality
- Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
- Countries
- 15
01
Overview
Phase 2, randomised, open-label trial in transitional cell carcinoma of the bladder (TCC) and Bladder cancer in situ (CIS) comparing TAR-200 + cetrelimab, TAR-200 alone and cetrelimab alone (3 arms). Primary endpoints: Overall complete response rate and Disease-free survival. Planned start May 2024; status: authorised.
02
Drugs
gemcitabine-releasing intravesical systemcetrelimab
03
Conditions
transitional cell carcinoma of the bladder (TCC)Bladder cancer in situ (CIS)
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