Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT02771626
Last Updated: 2023-03-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
118 participants
INTERVENTIONAL
2016-08-01
2020-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Telaglenastat 600 mg + Standard Dose Nivolumab
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic clear cell renal cell carcinoma (ccRCC), melanoma, and non-small cell lung cancer (NSCLC).
CB-839
Glutaminase inhibitor
Nivolumab
PD-1 inhibitor
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one tyrosine kinase inhibitor (TKI) but are treatment naïve to checkpoint modulators programmed death-1/programmed death ligand-1 (PD-1/PD-L1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
CB-839
Glutaminase inhibitor
Nivolumab
PD-1 inhibitor
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
CB-839
Glutaminase inhibitor
Nivolumab
PD-1 inhibitor
Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
CB-839
Glutaminase inhibitor
Nivolumab
PD-1 inhibitor
Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
CB-839
Glutaminase inhibitor
Nivolumab
PD-1 inhibitor
Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the epidermal growth factor receptor (EGFR) oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
CB-839
Glutaminase inhibitor
Nivolumab
PD-1 inhibitor
Interventions
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CB-839
Glutaminase inhibitor
Nivolumab
PD-1 inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Calithera Biosciences, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Sam Whiting, MD, PhD
Role: STUDY_DIRECTOR
Calithera Biosciences, Inc
Locations
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Honor Health
Scottsdale, Arizona, United States
Stanford University
Palo Alto, California, United States
University of Colorado
Aurora, Colorado, United States
University Cancer Blood Center
Athens, Georgia, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Caner Center
Detroit, Michigan, United States
New York University
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Seattle Cancer Care Alliance/University of Washington
Seattle, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Countries
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References
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Aden D, Sureka N, Zaheer S, Chaurasia JK, Zaheer S. Metabolic Reprogramming in Cancer: Implications for Immunosuppressive Microenvironment. Immunology. 2025 Jan;174(1):30-72. doi: 10.1111/imm.13871. Epub 2024 Oct 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CX-839-004
Identifier Type: -
Identifier Source: org_study_id
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