Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2020-04-24
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calithera Biosciences, Inc
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

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