NCT05048212

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a phase II study to assess the safety and efficacy of the combination of nivolumab with ipilimumab and cabozantinib in patients with untreated brain metastases from RCC until disease progression or intolerable toxicities or patient withdrawal. We will accrue a total of 40 patients. Patients will be treated with nivolumab (3mg/kg) and ipilimumab (1mg/kg) IV every 3 weeks for 4 doses and cabozantinib 40mg daily. Then patients will be treated with nivolumab 480mg IV Q 4 weeks and cabozantinib 40mg daily until progression or intolerable toxicities or patient's withdrawal. A lead-in group of 6 patients will be closely monitored for DLT. If stopping criteria (\>3 patients develop DLTs) is met then, treatment will be switched to Nivolumab plus Cabozantinib omitting ipilimumab.

Conditions

• Brain Metastases
• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Given by IV
DRUG	Ipilimumab	Given by IV
DRUG	Cabozantinib	Given by IV

Timeline

• Start date: 2022-09-20
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-09-17
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study