Clinical trial · Interventional
Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)
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
NCT02771626CI-TRIAL-00064784terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of efficacy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma (ccRCC) | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CB-839 | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Telaglenastat 600 mg + Standard Dose Nivolumab
- description
- 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).
- interventionNames
- Drug: CB-839
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors
- description
- 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.
- interventionNames
- Drug: CB-839
- Drug: Nivolumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAden 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. PMID 39462179