Trial Search Results
Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)
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.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
Calithera Biosciences, Inc
Stanford Investigator(s):
Intervention(s):
- Drug: CB-839
- Drug: Nivolumab
Phase:
Phase 1/Phase 2
Eligibility
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting