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Study CB-839 in Combination With Nivolumab in Patients With Melanoma, ccRCC and NSCLC

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ClinicalTrials.gov Identifier: NCT02771626
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date February 2, 2021
Study Start Date  ICMJE August 2016
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • Safety and Tolerability of CB-839 and Nivolumab: Incidence of adverse events [ Time Frame: Every 28 days from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months ]
  • Efficacy of CB-839 in Combination with Nivolumab: change in tumor size from baseline [ Time Frame: Every 28 days from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
  • Recommended Phase 2 Dose (RP2D) of CB-839 in Combination with Nivolumab [ Time Frame: 12 Weeks ]
    A minimum of 9-12 patients with ccRCC, melanoma, or NSCLC will be enrolled in Dose Escalation to determine RP2D.
  • Maximum plasma concentration of CB-839 in combination with Nivolumab [ Time Frame: Every 28 days from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months ]
    Non-compartmental method of analysis will be used to analyze the plasma concentrations of CB-839.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study CB-839 in Combination With Nivolumab in Patients With Melanoma, ccRCC and NSCLC
Official Title  ICMJE A Phase 1/2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Glutaminase Inhibitor CB-839 in Combination With Nivolumab in Patients With Advanced/Metastatic Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
Brief 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Clear Cell Renal Cell Carcinoma
  • Melanoma
  • Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: CB-839
    Glutaminase inhibitor
    Other Name: Glutaminase inhibitor
  • Drug: Nivolumab
    PD-1 inhibitor
    Other Names:
    • Opdivo
    • BMS-936558
Study Arms  ICMJE
  • Experimental: CB-839 + Nivolumab Dose Escalation
    Phase 1: CB-839 administered as oral capsules twice daily in combination with standard dose nivolumab in patients with advanced/metastatic ccRCC, MEL, and NSCLC to select the recommended Phase 2 dose (RP2D).
    Interventions:
    • Drug: CB-839
    • Drug: Nivolumab
  • Experimental: Clear Cell RCC Naïve to Checkpoint Inhibitors
    Cohort 1: CB-839/ nivolumab combination in patients with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naive to checkpoint modulators anti-PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
    Interventions:
    • Drug: CB-839
    • Drug: Nivolumab
  • Experimental: Clear Cell RCC Recently Treated with Nivolumab
    Cohort 2: CB-839/ nivolumab combination in patients with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
    Interventions:
    • Drug: CB-839
    • Drug: Nivolumab
  • Experimental: Clear Cell RCC with Prior PD-1 Therapy
    Phase 2 - Cohort 3: CB-839/ nivolumab combination in patients with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
    Interventions:
    • Drug: CB-839
    • Drug: Nivolumab
  • Experimental: Melanoma with Prior PD-1 Therapy
    Cohort 4: CB-839/ nivolumab combination in patients with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
    Interventions:
    • Drug: CB-839
    • Drug: Nivolumab
  • Experimental: NSCLC with Prior PD-1 Therapy
    Cohort 5: CB-839/ nivolumab combination with NSCLC that does not harbor an activating mutation in the epidermal growth factor receptor (EGFR) oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
    Interventions:
    • Drug: CB-839
    • Drug: Nivolumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2020)
118
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2016)
242
Actual Study Completion Date  ICMJE June 2020
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02771626
Other Study ID Numbers  ICMJE CX-839-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Calithera Biosciences, Inc
Study Sponsor  ICMJE Calithera Biosciences, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sam Whiting, MD, PhD Calithera Biosciences, Inc
PRS Account Calithera Biosciences, Inc
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP