NCT03635892

A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma

A Phase 2 Open-Label Study of Nivolumab Combined With Cabozantinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma (CA209-9KU)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare any good and bad effects of using a combination of nivolumab (Opdivo®) and cabozantinib (Cabometyx®) in people with metastatic kidney cancer.

Conditions

• Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma
• Unclassified Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma
• Fumarate Hydratase Deficient Renal Cell Carcinoma
• Succinate Dehydrogenase Deficient Renal Cell Carcinoma
• Collecting Duct Renal Cell Carcinoma
• Chromophobe Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	cabozantinib	cabozantinib 40mg, self administered orally once daily on a continuous schedule (days 1-28) Patients will continue to take cabozantinib until disease progression (unless continuing treatment beyond progression), major toxicity, or withdrawal from the study for any reason.
DRUG	nivolumab	Patients will receive an intravenous infusion of nivolumab, per institutional standards, at 240 mg on Cycle 1, Day 1 and will return to the center approximately every two weeks (14 ± 3 days) for subsequent infusions until disease progression (unless continuing treatment beyond progression), major toxicity, or withdrawal from the study for any reason.

Timeline

• Start date: 2018-08-13
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2018-08-17
• Last updated: 2025-09-22

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study