Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT07023432
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.
Study:
NCT07023432
Study Brief:
Protocol Section:
NCT07023432