Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-01 @ 4:07 AM
Study NCT ID:
NCT07023432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2025-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Belzutifan's Role in Active Surveillance Versus Treatment for Indolentmetastatic Clear Cell Renal Ccell Carcinoma (BRAVE-RCC)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
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 belzutifan can help to control the disease in patients with metastatic RCC who are considered candidates for active surveillance and have not undergone previous systemic treatment. The safety of belzutifan in this patient population will also be studied.
Detailed Description:
Primary Objectives
• To compare the progression-free survival difference for participants treated with belzutifan versus active surveillance as evaluated by RECIST 1.1 criteria.
Secondary Objectives
* To describe the safety profile of belzutifan in this population using CTCAE v5.0.
* To estimate the difference in time to start of new systemic treatment in participants treated with belzutifan versus active surveillance.
* To describe objective response rates (CR and PR) using RECIST 1.1 criteria.
Exploratory Objectives
* To describe methylated ctDNA characteristics for participants at baseline, during treatment, and at progression.
* To describe baseline tissue-based gene expression profiling and its association with outcome where tissue is available.
* To estimate differences in target lesion sum of diameters from baseline to start of next systemic therapy.
* To estimate differences in quality of life based on FKSI-19 questionnaire for participants on belzutifan versus surveillance.
* To describe PFS2 (time to second disease progression) in both arms.
* To describe overall survival in both groups.
* To describe the duration of objective response, duration of CR, and duration of SD using RECIST 1.1 criteria.
• To compare the progression-free survival difference for participants treated with belzutifan versus active surveillance as evaluated by RECIST 1.1 criteria.
Secondary Objectives
* To describe the safety profile of belzutifan in this population using CTCAE v5.0.
* To estimate the difference in time to start of new systemic treatment in participants treated with belzutifan versus active surveillance.
* To describe objective response rates (CR and PR) using RECIST 1.1 criteria.
Exploratory Objectives
* To describe methylated ctDNA characteristics for participants at baseline, during treatment, and at progression.
* To describe baseline tissue-based gene expression profiling and its association with outcome where tissue is available.
* To estimate differences in target lesion sum of diameters from baseline to start of next systemic therapy.
* To estimate differences in quality of life based on FKSI-19 questionnaire for participants on belzutifan versus surveillance.
* To describe PFS2 (time to second disease progression) in both arms.
* To describe overall survival in both groups.
* To describe the duration of objective response, duration of CR, and duration of SD using RECIST 1.1 criteria.
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-2025-04261 | OTHER | NCI-CTRP Clinical Registry | View |