ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With Renal Cell Carcinoma (RCC)

• Status: Completed
• Trial end date: 2020-05-11
• Target enrollment: 0
• Participant gender: All

Summary

Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calithera Biosciences, Inc
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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