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Clinical Trial Summary

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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05048212
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Jianbo Wang
Phone (713) 792-3393
Email jwang38@mdanderson.org
Status Recruiting
Phase Phase 2
Start date September 20, 2022
Completion date July 31, 2024

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