West Cancer Center

RENAL: METASTATIC: 2nd Line or later: CANTATA

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC) - CANTATA

Title

Calithera CX-839-008 (Renal)

Study Title

Site Link

NCT03428217

Malignancy

Renal Cell Carcinoma, Kidney Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd or 3rd line

Investigational Agent

CB-839

Drug Class

oral glutaminase inhibitor

Dan Vaena, MD

Sponsor

Calithera Biosciences

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Metastatic renal cell carcinoma with a clear cell component
Karnofsky PS 70% or higher
1-2 lines of prior therapy for advanced or metastaic RCC including at least one antiangiogenic therapy or nivolumab+ipilimumab
No prior treatment with cabozantinib or other MET inhibitor
No active CNS malignancies
No known HIV, HBV, HCV
No need for Proton -pump inhibitors

Objective

Primary- PFS; Secondary- OS, PFS by investigator assessment

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Clear cell component

Dosing Frequency

Control Agents

placebo plus cabozantinib

Study Protocol

Randomized

Yes