A Randomized Phase 3 Study Evaluating Cystectomy with Perioperative Pembrolizumab and Cystectomy with Perioperative Enfortumab Vedotin and Pembrolizumab versus Cystectomy Alone in Cisplatin-Ineligible Participants with Muscle-Invasive Bladder Cancer

General Information Age Group Adults Status Recruiting Protocol Number NCT03924895 Background Information The purpose of this study is to see if pembrolizumab before and after surgery is more effective than surgery alone in patients with muscle-invasive bladder cancer (MIBC). This will be measured by tissue samples that are taken during surgery as well as imaging performed at different time points. The study will test the safety of the study drug, pembrolizumab given before and after surgery, and see how well the body handles pembrolizumab before and after surgery. The study will help determine if pembrolizumab and surgery, compared to surgery alone, helps patients have a better quality of life and helps patients live longer. Offered At Inova Schar Cancer Institute 8081 Innovation Park Drive Fairfax, VA 22031 A department of Inova Fairfax Hospital Eligibility Information A histologically confirmed diagnosis of muscle invasive bladder cancer (T2-T4aN0M0) with predominant (≥50%) urothelial histology Have clinically non-metastatic bladder cancer (N0M0) determined by imaging (CT chest and CT or MRI of the abdomen/pelvis), confirmed by BICR Ineligible for treatment with cisplatin Additional eligibility in protocol Ineligibility Information A known additional non-urothelial malignancy that is progressing or has required active treatment in the last 3 years Prior systemic anti-neoplastic treatment for MIBC Prior radiotherapy to the bladder Additional ineligibility in protocol For more information, go to: https://clinicaltrials.gov/ct2/show/NCT03924895 Contact Information Contact Name Adeeba Ali Contact Phone 571-472-0616 Contact Email Send Email