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Protocol No. UW17083

Principal Investigator Emamekhoo, Hamid

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

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)

Objective The purpose of this study is to determine if CB-839 (an “investigational” drug), given together with everolimus (an “approved” drug) is able to stop or reduce the rate of cancer growth in patients with advanced or metastatic renal cell cancer. This study will also look at any possible effect that CB-839 in combination with everolimus may have on cancer. This study is placebo-controlled, meaning patient's are treated with the standard approved medication everolimus plus either CB-839 or an inactive pill (like a sugar pill).

Treatment CB-839 or placebo orally with Everolimus orally every day

Description A phase 2, randomized, placebo controlled study with CB-839 and Everolimus

Key Eligibility
  • Age ≥ 18 years, Karnofsky Performance Score (KPS) ≥ 70%, and Estimated Life Expectancy of at least 3 mo
  • Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
  • Measurable Disease
  • Must have received at least two prior lines of systemic therapy, including at least one VEGFR-targeting TKI
  • Must have received at least one of cabozantinib or nivolumab
  • Prior treatment with other anti-cancer therapies including cytokines, monoclonal antibodies, immunotherapies, and cytotoxic chemotherapy is allowed
  • Adequate hemotolgy, renal and liver function
  • Hemoglobin A1c <8%
  • Fasting serum triglycerides ≤ 2.5 × upper limit of normal AND total cholesterol ≤ 300 mg/dL. Lipid-lowering medication is allowed
  • Male and Female patients must use an effective barrier method of contraception
  • No prior treatment with mTOR inhibitors or CB-839
  • No prior current or previous malignancy within the past three years

  • Applicable Disease Sites Kidney

    Status Open

    Participating Institutions UW Hospital and Clinics