CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC) (ENTRATA)
Clear Cell Renal Cell Carcinoma
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma focused on measuring advanced, metastatic RCC, RCC, CB-839, Everolimus, CBE, Glutaminase Inhibitor, Glutaminase, Tumor Metabolism, Glutamine
Eligibility Criteria
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
Sites / Locations
- The University of Arizona Cancer Center
- Highlands Oncology Group
- Los Angeles Hematology Oncology Medical Group
- UCLA Department of Medicine - Hematology/Oncology
- Stanford Cancer Center
- Florida Cancer Specialists- South
- Florida Cancer Specialists- North
- University Cancer & Blood Center, LLC
- Northwest Georgia Oncology Centers, P.C.
- St. Luke's Mountain States Tumor Institute
- Northwestern University
- Parkview Research Center
- University of Iowa Hospitals and Clinics
- Norton Cancer Institute, Norton Healthcare Pavilion
- Ochsner Clinical Foundation
- Anne Arundel Medical Center Oncology and Hematology
- University of Maryland, Greenebaum Comprehensive Cancer Center
- Metro-Minnesota Community Oncology Research Consortium
- Mercy Clinic Oncology & Hematology
- SCRI HCA Midwest
- Washington University School of Medicine
- St. Vincent Frontier Cancer Center
- Comprehensive Cancer Centers of Nevada
- Montefiore Medical Center
- North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists
- NYU Winthrop Hospital - Cancer Clinical Trials Oncology/Hematology
- Memorial Sloan Kettering Cancer Center
- SUNY Upstate Medical University
- University of Cincinnati Medical Center
- Ann B. Barshinger Cancer Institute / Lancaster General Hospital
- Monongahela Valley Hospital
- Charleston Hematology Oncology Associates,PA
- UT/Erlanger Oncology & Hematology
- Sarah Cannon Research Institute - Tennessee Oncology
- The University of Texas MD Anderson Cancer Center
- Utah Cancer Specialists
- Wenatchee Valley Hospital and Clinics
- University of Wisconsin Carbone Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
CB-839 + Everolimus
Placebo + Everolimus
CB-839 is administered as oral tablets twice daily (BID) in combination with standard daily (QD) everolimus in 28 day cycles.
Placebo is administered as oral tablets BID in combination with standard QD everolimus in 28 day cycles.