Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)
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
California
Palo Alto
Colorado
Aurora
Massachusetts
Boston
Michigan
Detroit
New York
New York
Ohio
Cleveland
Pennsylvania
Philadelphia
Tennessee
Nashville
Texas
Houston
Washington
Seattle
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.
During Phase 1, patients will be enrolled into escalating dose cohorts to determine the
recommended phase 2 dose (RP2D).
In Phase 2, patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung
cancer will be enrolled into separate cohorts.
All patients will be assessed for safety, pharmacokinetics, biomarkers and tumor response.
Trial Phase Phase I/II
Trial Type Treatment
Lead Organization
Calithera Biosciences, Inc
- Primary ID CX-839-004
- Secondary IDs NCI-2016-00900, s17-00293
- Clinicaltrials.gov ID NCT02771626