NCT06434350

Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of enfortumab vedotin plus radiation therapy could help to control the disease.

Detailed 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 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.

Conditions

• Advanced Bladder Cancer

Interventions

Type	Name	Description
DRUG	Enfortumab Vedotin	Given by IV
RADIATION	Radiation Therapy	Given by Radiation Therapy

Timeline

• Start date: 2024-10-10
• Primary completion: 2027-09-24
• Completion: 2027-09-24
• First posted: 2024-05-30
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study