CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

Status: Active

Description

This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma.

Eligibility Criteria

Inclusion Criteria

  • Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
  • Adult patients
  • Karnofsky Performance Score (KPS) ≥ 70%
  • Measurable Disease per RECIST 1.1
  • 1-2 lines of prior therapy for advanced or metastatic RCC including at least one antiangiogenic therapy or nivolumab + ipilimumab
  • Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria

  • Prior treatment with cabozantinib (or other MET inhibitor) or CB-839
  • Receipt of other anticancer therapy within 2 - 6 weeks, depending on the treatment
  • Untreated or active brain metastases or central nervous system cancer, as defined per protocol
  • Prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug
  • Known active infection with HIV, Hepatitis B or C virus
  • Requirement for continued proton pump inhibitor after randomization

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available
Tucson
The University of Arizona Medical Center-University Campus
Status: Active
Name Not Available

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: Active
Name Not Available
San Diego
University of California San Diego
Status: Active
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Illinois

Chicago
Northwestern University
Status: Active
Name Not Available
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Michele Ann Besche
Phone: 410-328-8610
Email: mbesche@umm.edu

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: Active
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

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available
Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Utah

Farmington
Farmington Health Center
Status: Active
Name Not Available
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Objectives and Outline

This study is a randomized Phase 2 evaluation of CB-839 in combination with cabozantinib versus placebo with cabozantinib in Renal Cell Carcinoma patients with at least one and not more than 2 prior therapies in the advanced or metastatic setting.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Calithera Biosciences, Inc

Trial IDs

Primary ID CX-839-008
Secondary IDs NCI-2018-00448
Clinicaltrials.gov ID NCT03428217