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

Completed · Phase 2 · Has a placebo group

Conditions studied: Clear Cell Renal Cell Carcinoma

In brief

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

Key facts

Study ID

NCT03163667

Run by

Calithera Biosciences, Inc

People needed

69

Starts

2017-09-06

Expected to finish

2020-06-01

Last updated by the study team

2022-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Arizona Cancer Center — Tucson, Arizona, United States
• Highlands Oncology Group — Rogers, Arkansas, United States
• Los Angeles Hematology Oncology Medical Group — Los Angeles, California, United States
• UCLA Department of Medicine - Hematology/Oncology — Los Angeles, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Florida Cancer Specialists- South — Fort Myers, Florida, United States
• Florida Cancer Specialists- North — St. Petersburg, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Northwest Georgia Oncology Centers, P.C. — Marietta, Georgia, United States
• St. Luke's Mountain States Tumor Institute — Boise, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Norton Cancer Institute, Norton Healthcare Pavilion — Louisville, Kentucky, United States
• Ochsner Clinical Foundation — New Orleans, Louisiana, United States
• Anne Arundel Medical Center Oncology and Hematology — Annapolis, Maryland, United States
• University of Maryland, Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• Metro-Minnesota Community Oncology Research Consortium — Saint Louis Park, Minnesota, United States
• Mercy Clinic Oncology & Hematology — Joplin, Missouri, United States
• SCRI HCA Midwest — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• St. Vincent Frontier Cancer Center — Billings, Montana, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists — East Setauket, New York, United States
• NYU Winthrop Hospital - Cancer Clinical Trials Oncology/Hematology — Mineola, New York, United States

Full record on ClinicalTrials.gov

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