ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC

Status: Closed to Accrual


Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC

Eligibility Criteria

Inclusion Criteria

  • Karnofsky Performance Score (KPS) ≥ 70%
  • Estimated Life Expectancy of at least 3 mo
  • Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component.
  • Measurable Disease per RECIST 1.1 as determined by the Investigator
  • Must have received at least two prior lines of systemic therapy, including at least one VEGFR-targeting TKI (e.g., sunitinib, sorafenib, pazopanib, cabozantinib) a) Radiographic progression of mRCC must have occurred (per investigator assessment) on or after the most recent systemic therapy and within 6 mo prior to C1D1.
  • Prior treatment with other anti-cancer therapies including cytokines, monoclonal antibodies, immunotherapies, and cytotoxic chemotherapy is allowed

Exclusion Criteria

  • Prior treatment with mTOR inhibitors (everolimus or temsirolimus) or CB-839
  • Receipt of any anticancer therapy within the following windows before randomization:
  • TKI therapy within 2 weeks or 5 half-lives, whichever is longer
  • Any type of anti-cancer antibody within 4 weeks
  • Cytotoxic chemotherapy within 4 weeks
  • Investigational therapy within 4 weeks or 5 half-lives, whichever is longer
  • Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  • Unable to receive medications PO or any condition that may prevent adequate absorption of oral study medication
  • Major surgery within 28 days prior to randomization
  • Patients with active and/or untreated central nervous system (CNS) cancer are not eligible. Patients with treated brain metastasis must have 1) documented radiographic stability of at least 4 weeks duration demonstrated on baseline contrast-enhanced CNS imaging (eg contrast-enhanced MRI of the brain) prior to randomization and 2) must be symptomatically stable and off steroids for at least 2 weeks before randomization.
  • Requirement for continued proton pump inhibitor after randomization
  • Chronic treatment with corticosteroids or other immunosuppressive agents except (i) inhaled or topical steroids or replacement dose corticosteroids equivalent to ≤ 10 mg prednisone and (ii) patients receiving physiological doses of hydrocortisone for adrenal insufficiency

Locations & Contacts


Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Kim Kelly
Phone: 310-206-8309
Email: kmkelly@mednet.ucla.edu


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

New York

Montefiore Medical Center-Einstein Campus
Status: Active
Name Not Available


M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

Trial Phase & Type

Trial Phase

Phase II

Trial Type


Lead Organization

Lead Organization
Calithera Biosciences, Inc

Trial IDs

Primary ID CX-839-005
Secondary IDs NCI-2017-01576
Clinicaltrials.gov ID NCT03163667