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Clinical trial of TAR-200 with cetrelimab versus intravesical bacillus Calmette-Guérin (BCG) in patients with non-muscle-invasive bladder cancer.
THE AIM OF THIS STUDY IS TO COMPARE THE EFFECTS (BOTH GOOD AND BAD) OF THE INVESTIGATIONAL DRUG DELIVERY SYSTEM (TAR-200) IN COMBINATION WITH CETRELIMAB WITH THE EFFECTS OF THE COMPARATIVE STUDY DRUG BCG INTRAVESICAL (DRUG THAT IS PLACED DIRECTLY INTO THE BLADDER INSTEAD OF BEING TAKEN AS A PILL OR INJECTED INTO THE VEINS) IN PATIENTS WITH UROTHELIAL CANCER. IN ADDITION TO ANALYZING THE EFFECT OF THESE TREATMENTS ON BLADDER CANCER, THIS STUDY WILL ALSO BE USED TO FIND OUT HOW LONG THE STUDY DRUG STAYS AND ACTS IN THE BODY. THIS IS DETERMINED BY BLOOD AND URINE TESTS. THESE TESTS WILL ALSO FIND OUT IF THE STUDY DRUG CAN CAUSE SIDE EFFECTS, WHICH ARE UNEXPECTED OR UNWANTED REACTIONS RESULTING FROM THE ADMINISTRATION OF A DRUG.
Technical Summary
- AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TAR-200 IN COMBINATION WITH CETRELIMAB AGAINST INTRAVESICAL BACILLUS CALMETTE-GUÉRIN (BCG) IN PATIENTS WITH HIGH-RISK NON-MUSCLE-INVASIVE BLADDER CANCER (NMIBC-AR) WITHOUT PRIOR BCG TREATMENT. IMMUNOTHERAPY
- Code EudraCT: 2020-004506-64
- Protocol number: 17000139BLC3002
- Promoter: Janssen-Cilag
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