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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
  Purpose
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.

Condition Intervention Phase
Clear Cell Renal Cell Carcinoma Melanoma Non-small Cell Lung Cancer Drug: CB-839 Drug: Nivolumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Calithera Biosciences, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 242
Study Start Date: August 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: CB-839
Glutaminase inhibitor
Other Name: Glutaminase inhibitor
Drug: Nivolumab
PD-1 inhibitor
Other Names:
  • Opdivo
  • BMS-936558
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.
Drug: CB-839
Glutaminase inhibitor
Other Name: Glutaminase inhibitor
Drug: Nivolumab
PD-1 inhibitor
Other Names:
  • Opdivo
  • BMS-936558
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.
Drug: CB-839
Glutaminase inhibitor
Other Name: Glutaminase inhibitor
Drug: Nivolumab
PD-1 inhibitor
Other Names:
  • Opdivo
  • BMS-936558
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.
Drug: CB-839
Glutaminase inhibitor
Other Name: Glutaminase inhibitor
Drug: Nivolumab
PD-1 inhibitor
Other Names:
  • Opdivo
  • BMS-936558
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.
Drug: CB-839
Glutaminase inhibitor
Other Name: Glutaminase inhibitor
Drug: Nivolumab
PD-1 inhibitor
Other Names:
  • Opdivo
  • BMS-936558
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.
Drug: CB-839
Glutaminase inhibitor
Other Name: Glutaminase inhibitor
Drug: Nivolumab
PD-1 inhibitor
Other Names:
  • Opdivo
  • BMS-936558

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771626


Contacts
Contact: Clinical Trials Administrator clinicaltrials@calithera.com

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Belle Li       belleli@stanford.edu   
Contact: Denise Haas       dhaas@stanford.edu   
Principal Investigator: Alice Fan, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Elaine Lam, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: David McDermott, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Nicole Ciccolo       NCICCOLO@mgh.harvard.edu   
Principal Investigator: Richard Lee, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact    855-320-2090      
Principal Investigator: Geoffrey Shapiro, MD         
United States, Michigan
Karmanos Caner Center Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Ulka Vaishampayan, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10655
Principal Investigator: Martin Voss, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Funda Meric-Bernstam, MD         
United States, Washington
Seattle Cancer Care Alliance/University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Vivian Nguyen       vnguyen@seattlecca.org   
Principal Investigator: Scott Tykodi, MD, PhD         
Northwest Medical Specialties Recruiting
Tacoma, Washington, United States, 98405
Contact: Linda Dhaene, BSN,RN       LDhaene@nwmsonline.com   
Principal Investigator: Jorge Chaves, MD         
Sponsors and Collaborators
Calithera Biosciences, Inc
Investigators
Study Director: Sam Whiting, MD, PhD Calithera Biosciences, Inc
  More Information

Responsible Party: Calithera Biosciences, Inc
ClinicalTrials.gov Identifier: NCT02771626     History of Changes
Other Study ID Numbers: CX-839-004
First Submitted: May 6, 2016
First Posted: May 13, 2016
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Calithera Biosciences, Inc:
RCC
MEL
NSCLC
Immuno-Oncology
Tumor Metabolism
Glutaminase
Glutaminase Inhibitor

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs