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#
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.
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
- - 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
- - 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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