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Trial record 1 of 2 for:    CB-839 lung
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Study CB-839 in Combination With Nivolumab in Patients With ccRCC and Other Solid Tumors

This study is currently recruiting participants.
Verified September 2017 by Calithera Biosciences, Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02771626
First Posted: May 13, 2016
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Calithera Biosciences, Inc
May 6, 2016
May 13, 2016
September 19, 2017
August 2016
December 2018   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT02771626 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study CB-839 in Combination With Nivolumab in Patients With ccRCC and Other Solid Tumors
A Phase 1/2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Glutaminase Inhibitor CB-839 in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma and Other Solid Tumors
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Clear Cell Renal Cell Carcinoma
  • Melanoma
  • Non-small Cell Lung Cancer
  • Drug: CB-839
    Glutaminase inhibitor
    Other Name: Glutaminase inhibitor
  • Drug: Nivolumab
    PD-1 inhibitor
    Other Names:
    • Opdivo
    • BMS-936558
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
242
June 2019
December 2018   (Final data collection date for primary outcome measure)

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 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, non-stable brain metastases or CNS disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Clinical Trials Administrator clinicaltrials@calithera.com
United States
 
 
NCT02771626
CX-839-004
No
Not Provided
Plan to Share IPD: No
Calithera Biosciences, Inc
Calithera Biosciences, Inc
Not Provided
Study Director: Sam Whiting, MD, PhD Calithera Biosciences, Inc
Calithera Biosciences, Inc
September 2017

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