Clareo Health | Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Calithera Biosciences, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Addition eligibility criteria based on tumor type apply
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
You may not be if
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
