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

Trial ID or NCT#

NCT02771626

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Alice C. Fan
Alice C. Fan
Medical oncologist, Genitourinary specialist
Assistant Professor of Medicine (Oncology) and, by courtesy, of Urology
Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

CCTO
(650) 498-7061

View on ClinicalTrials.gov