M.D. Anderson Cancer Center
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.
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 base…
Inclusion Criteria 1. Metastatic clear cell renal cell carcinoma, with or without sarcomatoid features, clinically apparent less than 12 months. 2. Male/female participants must be at least 18 years of age on the day of signing informed consent. 3. IMDC risk score of 0 or 1. 4. No prior systemic treatment for ccRCC. Adjuvant immunotherapy or targeted treatments allowed if progressive disease is noted at least 12 months after last dose of immunotherapy. 5. Metastatic disease that is documented by imaging with CT or MRI and measurable by RECIST1.1. 6. Participants must have signed and dated an…
Given by PO
Given by Observation
Arctuva estimate
Verify or correct the compensation shown for this listing.