Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
M.D. Anderson Cancer Center
Summary
To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.
Description
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 met…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Pathologically confirmed diagnosis of urothelial carcinoma of the bladder including patients with T4N0 and T1-4N2-3 disease. Participants with mixed urothelial carcinoma of bladder will also be included. 2. Be ≥ 18 years of age on the day of signing informed consent. 3. ECOG performance status 0-2. NOTE: If participants is unable to walk due to paralysis, but is mobile in a wheelchair, participants is ambulatory for the purpose of assessing their performance status. 4. The participant has the following baseline laboratory data: 1. Hemoglobin ≥ 9 g/dL 2. Platelet…
Interventions
- DrugEnfortumab Vedotin
Given by IV
- RadiationRadiation Therapy
Given by Radiation Therapy
Location
- MD Anderson Cancer CenterHouston, Texas