Advanced Bladder Cancer Clinical Trial
Official title:
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.
Primary Objectives: 1. Primary Objective #1: To estimate progression free survival for concurrent enfortumab vedotin with RT in locally advanced MIBC 2. Primary Objective #2: To evaluate the safety/tolerability of enfortumab vedotin with RT in participants with locally advanced MIBC 3. Primary Objective #3: To evaluate global health-related quality of life (HRQOL) using EQ-5D-5L, EORTC MIBC module, and EPIC bowel domain surveys Secondary Objectives: 1. Secondary Objective #1: To estimate the overall survival at 12 months after study enrollment. 2. Secondary Objective #2: To estimate the metastasis free survival at 12 months after study enrollment. 3. Secondary Objective #3: To determine the treatment related toxicities associated with enfortumab vedotin with RT as part of definitive local therapy for advanced MIBC. 4. Secondary Objective #4: To estimate the freedom from GU events after enfortumab vedotin with RT 5. Exploratory Objective #1: To determine the association of translational biomarkers including peripheral blood tumor markers and urine tumor markers with participant outcomes. ;