Lung Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT02771626

Recruitment Status:

Terminated

Sponsor:

Calithera Biosciences, Inc

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There are 16 Locations for this study

See Locations Near You

Honor Health
Scottsdale Arizona, 85016, United States
Stanford University
Palo Alto California, 94304, United States
University of Colorado
Aurora Colorado, 80045, United States
University Cancer Blood Center
Athens Georgia, 30607, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02114, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Karmanos Caner Center
Detroit Michigan, 48201, United States
New York University
New York New York, 10016, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10655, United States
University Hospitals Cleveland
Cleveland Ohio, 44106, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Vanderbilt University
Nashville Tennessee, 37232, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Seattle Cancer Care Alliance/University of Washington
Seattle Washington, 98109, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

118

Study ID:

NCT02771626

Recruitment Status:

Terminated

Sponsor:


Calithera Biosciences, Inc

How clear is this clinincal trial information?

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