Phase II Study of Nivolumab, Ipilimumab, and Cabozantinib for Untreated Brain Metastases from Renal Cell Carcinoma

What this Trial Is About

This trial investigates a phase II study of combining three drugsnivolumab, ipilimumab, and cabozantinibin patients who have untreated brain metastases from renal cell carcinoma RCC. The purpose is to evaluate the safety and effectiveness of this combination treatment until the disease worsens, side effects become intolerable, or the patient chooses to stop. The study plans to enroll 40 patients and includes a safety lead-in group of 6 patients to closely monitor early side effects. Participants initially receive nivolumab and ipilimumab intravenously every three weeks for four doses, along with daily oral cabozantinib. After this initial phase, nivolumab is given intravenously every four weeks with continued daily cabozantinib until disease progression or intolerable side effects occur. If more than three patients in the lead-in group experience serious side effects, the treatment will be adjusted to exclude ipilimumab. During the study, patients will undergo assessments including MRI scans to measure brain tumors, blood tests to check organ function, and monitoring for side effects. The main outcome measured is intracranial progression-free survival over about one year. Participants will be regularly evaluated throughout treatment with ongoing safety monitoring until the study ends.

A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases