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A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy
Janssen Research & Development, LLC
This trial includes a screening phase (42 days), a treatment phase and a follow up phase. The total duration of the trial is up to 8 years. For the treatment phase of the trial, participants will be randomly allocated to one of two arms. In the experimental arm, participants will receive intravesical (meaning, within the bladder) TAR-200 every 3-weeks for the first 18 weeks and every 12 weeks from week 24 through to Year 3, in combination with Cetrelimab. Participants not allocated to the experimental arm will receive either cisplatin or gemcitabine chemotherapy (as chosen by the investigator) for 6-weeks, along with radiotherapy for up to 4-weeks.