SunRISe-3: This study is comparing the effectiveness of standard treatment with immunotherapy to a new treatment using chemotherapy in people with BCG-niave high-risk non-muscle invasive bladder cancerA Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

Summary

This study is recruiting people with high grade non-muscle invasive bladder cancer who have not had prior treatment with Bacillus Calmette-Guerin (BCG). Eligible participants will be randomly allocated to one of three treatment arms. In Arm A (Experimental), participants will receive TAR-200 + targeted therapy (centrelimab). TAR-200 involves chemotherapy (gemcitabine + osmotic minitablets) being administered directly into the bladder using a catheter (intravesically) once every 3 weeks. In Arm B (Active Comparator), participants will receive immunotherapy, called Bacillus Calmette-Guerin (BCG) Vesiculture. BCG will be administered intravesically once every 6 weeks (induction therapy) followed by once every week for 3 weeks starting at Weeks 12, 24, 48, 72, and 96 (maintenance therapy). In Arm C (Experimental), participants will receive TAR-200 alone. TAR-200 will be administered intravesically once every 3 weeks.