Clinical Trials | C5701009: A Phase 3, Open-Label, Randomized Study to Evaluate Enfortumab Vedotin in Combination with Pembrolizumab in Adult Participants with Muscle-Invasive Bladder Cancer Who Are Ineligible for Or Have Elected Not to Undergo Cystectomy

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Muscle Invasive Bladder Cancer for a research study. The purpose of the study is to evaluate the safety and effects of the study drugs, enfortumab vedotin and pembrolizumab, when given together, with the available approved treatments for MIBC. The goal is to find out which is better for treating MIBC in patients who can’t get or don’t want to get their bladder removed. About 390 people will take part in this study. There are 2 different groups in this study that will get 2 different drug combinations. • Arm A) Enfortumab vedotin plus pembrolizumab • Arm B) cCRT (Concurrent Chemoradiotherapy) Concurrent chemoradiotherapy means giving radiation treatment at the same time as chemotherapy. The chemotherapy helps make the radiation work better. If you take part in the study, your participation will last for the following duration: • Arm A: Approximately 1 year, which includes 9 cycles of enfortumab vedotin + Pembrolizumab followed by 8 cycles of Pembrolizumab alone (each cycle is about 3 weeks). • Arm B: Up to 14.5 weeks, including up to 8 weeks of radiation planning and either 4 or 6.5 weeks of Concurrent Chemoradiotherapy (radiation and chemotherapy treatment together). In both groups, patients will continue having follow-up visits even after treatment ends. These check-ins happen every 12 weeks (about every 3 months). In addition, a separate type of visit — called survival follow-up — is also required every 12 weeks to check on your overall health and whether any new treatments have started. You will be asked to complete study visits about 29 times (Arm A) or 28-43 times (Arm B) at the study site. Stipend/Travel Reimbursement - $114.00 per visit Hotel Reimbursement - $200.00 per night Additional information found here: https://clinicaltrials.gov/study/NCT07566156 For questions, contact: [email protected]