Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434350
Status:
SUSPENDED
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer CONSOLIDATE
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer CONSOLIDATE
Status:
SUSPENDED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Request
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 safetytolerability 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 safetytolerability 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04592 | OTHER | NCI-CTRP Clinical Registry | None |