NCT04413123

Cabozantinib In Combo With NIVO + IPI In Advanced NCCRCC

A Phase 2 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Advanced Non-Clear Cell Renal Cell Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Bradley A. McGregor, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study will assess whether cabozantinib, nivolumab and ipilimumab in combination are safe and effective in slowing down the growth of kidney cancer(renal cell carcinoma or RCC) that has advanced or spread to other areas the body.

Detailed description

This research study involves an investigational drug combination not approved by the FDA (the U.S. Food and Drug Administration) for your kidney cancer. The names of the study drugs in this investigational combination are: * Cabozantinib * Nivolumab * Ipilimumab The research study procedures include screening for eligibility, study treatment, participant evaluations and safety follow-up visits, in addition to general health status follow-up after study treatment. It is expected that about 40 people will take part in this research study.

Conditions

• Papillary Renal Cell Carcinoma
• Unclassified Renal Cell Carcinoma
• Translocation Renal Cell Carcinoma
• Chromophobe Renal Cell Carcinoma
• Collecting Duct Renal Cell Carcinoma
• Renal Cell Carcinoma
• Unresectable Advanced Renal Cell Carcinoma
• Metastatic Ncc Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib	Cabozantinib predetermined protocol dosage po daily
DRUG	Nivolumab	Nivolumab predetermined protocol dosage via IV every 3 weeks
DRUG	Ipilimumab	Ipilimumab predetermined protocol dosage via IV every 3 weeks

Timeline

• Start date: 2020-11-05
• Primary completion: 2026-06-20
• Completion: 2026-12-20
• First posted: 2020-06-02
• Last updated: 2026-01-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study