Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-04 @ 4:54 AM
Study NCT ID:
NCT06434350
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2024-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-04592 | OTHER | NCI-CTRP Clinical Registry | View |