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

Phase 2

Active, not recruiting

• Conditions: Brain Metastases; Renal Cell Carcinoma
• Interventions: Drug: Nivolumab; Drug: Ipilimumab; Drug: Cabozantinib

• Registration Number: NCT05048212
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-17
• Study Start: 2022-09-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab	Nivolumab	by vein every 3 weeks for 4 doses
Nivolumab	Ipilimumab	by vein every 3 weeks for 4 doses
Nivolumab	Cabozantinib	by vein every 3 weeks for 4 doses
Ipilimumab	Ipilimumab	by vein over 30 minutes every 3 weeks for 4 doses
Ipilimumab	Nivolumab	by vein over 30 minutes every 3 weeks for 4 doses
Ipilimumab	Cabozantinib	by vein over 30 minutes every 3 weeks for 4 doses
Cabozantinib	Nivolumab	tablets by mouth 1 time every day.
Cabozantinib	Ipilimumab	tablets by mouth 1 time every day.
Cabozantinib	Cabozantinib	tablets by mouth 1 time every day.

Primary Outcome Measures

Name	Time	Method
To associate if the combination of nivolumab with ipilimumab and cabozantinib produces improvesintracranial progression-free survival (PFS) in patients.	through study completion, an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States