A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Status: Closed to Accrual


The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Eligibility Criteria

Inclusion Criteria

  • Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
  • Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
  • No prior systemic therapy for RCC with the following exception: i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

Exclusion Criteria

  • Any active CNS metastases
  • Any active, known or suspected autoimmune disease
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization

Locations & Contacts


Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Vince Basehart
Phone: 310-267-8954
Email: vbasehart@mednet.ucla.edu


OHSU Knight Cancer Institute
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type


Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-9ER
Secondary IDs NCI-2017-01694, 2017-000759-20
Clinicaltrials.gov ID NCT03141177