Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)

Not Recruiting

Trial ID: NCT02771626

Purpose

This study is an open-label Phase 1/2 evaluation of CB-839 in combination with nivolumab in participants with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.

Official Title

A Phase 1/2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Glutaminase Inhibitor CB-839 in Combination With Nivolumab in Patients With Advanced/Metastatic Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer

Stanford Investigator(s)

Alice C. Fan
Alice C. Fan

Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

Eligibility


Addition eligibility criteria based on tumor type apply

Inclusion Criteria:

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

   - Histological or cytological diagnosis of metastatic cancer or locally advanced cancer
   that is not amenable to local therapy

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
   criteria

   - Resolution of treatment-related toxicities except alopecia

Exclusion Criteria:

   - Unable to receive oral medications

   - Unable to receive oral or intravenous (IV) hydration

   - Intolerance to prior anti-PD-1/PD-L1 therapy

   - Prior severe hypersensitivity reaction to another monoclonal antibody (mAb)

   - Any other current or previous malignancy within 3 years except protocol allowed
   malignancies

   - Chemotherapy, TKI therapy, radiation therapy or hormonal therapy within 2 weeks

   - Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note:
   Some cohort exceptions allow anti-PD-1 therapy)

   - Active known or suspected exclusionary autoimmune disease

   - Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily
   prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks

   - History of known risks factors for bowel perforation

   - Symptomatic ascites or pleural effusion

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring parenteral antibiotics, antivirals, or antifungals within 2
   weeks prior to first dose of study drug

   - Patients who have human immunodeficiency virus (HIV), Hepatitis B or C

   - Conditions that could interfere with treatment or protocol-related procedures

   - Active and/or untreated central nervous system (CNS) disease or non-stable brain
   metastases

Intervention(s):

drug: CB-839

drug: Nivolumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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