ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC
Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC
- 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
- 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
Contact: Kim Kelly
Contact: Michele Ann Besche
Name Not Available
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
Calithera Biosciences, Inc
Secondary IDs NCI-2017-01576
Clinicaltrials.gov ID NCT03163667