CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC)

Not Recruiting

Trial ID: NCT03163667


The primary objective of this study is to compare the progression-free survival (PFS) of participants treated with telaglenastat and everolimus versus placebo and everolimus for advanced or metastatic clear cell renal cell carcinoma (ccRCC) previously treated with the following: - At least 2 lines of therapy, including at least 1 vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI) - Radiographic progression of metastatic RCC must have occurred (per investigator assessment) on or after the most recent systemic therapy and within 6 months prior to cycle 1 day 1

Official Title

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)

Stanford Investigator(s)

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


Inclusion Criteria:

   - Karnofsky Performance Score (KPS) ≥ 70%

   - Estimated Life Expectancy of at least 3 months

   - Documented histological or cytological diagnosis of renal cell carcinoma with a
   clear-cell component.

   - Measurable Disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as
   determined by the Investigator

   - Must have received at least two prior lines of systemic therapy, including at least
   one VEGF 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 months prior to Cycle 1 Day
   1 (C1D1).

   - Prior treatment with other anti-cancer therapies including cytokines, monoclonal
   antibodies, immunotherapies, and cytotoxic chemotherapy is allowed

Exclusion Criteria:

   - Prior treatment with mammalian target of rapamycin (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 orally (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 magnetic resonance imaging [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


drug: Placebo

drug: CB-839

drug: everolimus

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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