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

Status: Active

Description

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

Arizona

Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Name Not Available

California

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

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Approved
Name Not Available
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Christian Hospital
Status: Active
Name Not Available
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Robert J. Motzer
Phone: 646-888-4722
Email: motzerr@mskcc.org

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

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