Trial Search Results

Study CB-839 in Combination With Nivolumab in Patients With Melanoma, ccRCC and 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 RECISTv1.1 criteria

   - Resolution of treatment-related toxicities except alopecia

Exclusion Criteria:

   - Unable to receive oral medications

   - Unable to receive oral or 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, Tyrosine Kinase Inhibitor 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 HIV, Hepatitis B or C

   - Conditions that could interfere with treatment or protocol-related procedures

   - Active and/or untreated 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