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GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients

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.
 
ClinicalTrials.gov Identifier: NCT02575404
Recruitment Status : Recruiting
First Posted : October 14, 2015
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
Galectin Therapeutics Inc.
Information provided by (Responsible Party):
Providence Health & Services

Tracking Information
First Submitted Date  ICMJE October 9, 2015
First Posted Date  ICMJE October 14, 2015
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE May 16, 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
Frequency and Severity of Treatment-Related Adverse Events Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: 85 Days ]
Patients are seen in clinic 7 times over 85 days. At each visit, a research nurse performs a toxicity check. Patients have 5 physical exams during the 85-day period.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2017)
  • Measure the response rate to combined therapy with GR-MD-02 and pembrolizumab in patients. [ Time Frame: Baseline and at Day 85 ]
    Patients will have PET and CT scans at baseline and after 85 days to assess response to treatment.
  • Assess the biological activity of GR-MD-02 in combination with pembrolizumab. [ Time Frame: 85 Days ]
    Patients will provide 5 blood samples over 85 days to measure the absolute number of CD4+T Cells, CD8+ T cells and melanoma-specific T cells
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
  • Measure the response rate to combined therapy with GR-MD-02 and pembrolizumab in patients with metastatic melanoma. [ Time Frame: Baseline and at Day 85 ]
    Patients will have PET and CT scans at baseline and after 85 days to assess response to treatment.
  • Assess the biological activity of GR-MD-02 in combination with pembrolizumab. [ Time Frame: 85 Days ]
    Patients will provide 5 blood samples over 85 days to measure the absolute number of CD4+T Cells, CD8+ T cells and melanoma-specific T cells
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients
Official Title  ICMJE Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Pembrolizumab in Patients With Metastatic Melanoma, Non-Small Cell Lung Cancer, and Head and Neck Squamous Cell Carcinoma.
Brief Summary This study is a dose escalation of GR-MD-02 with the standard therapeutic dose of pembrolizumab in patients with advanced melanoma, non-small cell lung cancer, and head and neck squamous cell cancer.
Detailed Description

This study will employ a 3+3 phase I design with dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of pembrolizumab in patients with advanced melanoma who have had progression after ipilimumab and/or BRAF targeted therapy when a BRAF mutation is present, non-small cell lung cancer patients with disease progression after targeted therapy, or head and neck squamous cell carcinoma patients with disease progression after at least one platinum-containing regimen.

In addition to monitoring for toxicity and clinical response, blood and tumor samples will be obtained to assess immunologic measures relevant to galectin biology and pembrolizumab T-cell checkpoint inhibition.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Drug: GR-MD-02
    Patients will receive five doses of GR-MD-02 intravenously over 85 Days.
    Other Name: Galactoarabino-rhamnogalactouronate
  • Drug: Pembrolizumab
    Patients will receive five 200mg doses of pembrolizumab intravenously over 85 days. After 85 days, patients may continue to receive pembrolizumab every 3 weeks if clinical benefit is noted.
    Other Name: Keytruda
Study Arms  ICMJE
  • Experimental: 2 mg/kg GR-MD-02
    2 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
    Interventions:
    • Drug: GR-MD-02
    • Drug: Pembrolizumab
  • Experimental: 4 mg/kg GR-MD-02
    4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
    Interventions:
    • Drug: GR-MD-02
    • Drug: Pembrolizumab
  • Experimental: 8 mg/kg GR-MD-02
    8 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
    Interventions:
    • Drug: GR-MD-02
    • Drug: Pembrolizumab
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2015)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with metastatic or unresectable melanoma for whom treatment with pembrolizumab is indicated. Histological confirmation of melanoma will be required by previous biopsy or cytology.
  • Patients with non-small cell lung cancer for whom treatment with pembrolizumab is indicated.
  • Patients with squamous cell carcinoma of the head and neck for whom treatment with pembrolizumab is indicated
  • Patients who have radiographic progression using Response Evaluation Criteria In Solid Tumors (RECIST) currently on pembrolizumab are also eligible.
  • Patients must be ≥ 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
  • No active bleeding.
  • Anticipated lifespan greater than 12 weeks.
  • Patients must sign a study-specific consent document.

Exclusion Criteria:

  • Patients who have previously received a galectin antagonist
  • Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo
  • Patients with history of colitis
  • Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
  • Other active metastatic cancer requiring treatment.
  • Patients with active infection requiring antibiotics.
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
  • Need for chronic steroids. Inhaled corticosteroids are acceptable.
  • Laboratory values (to be performed within 28 days of enrollment) outside of protocol-specified ranges.
  • Inability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
  • Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures.
  • Unresolved immune-mediated pneumonitis, diarrhea, elevation of hepatocellular enzymes or other toxicities requiring greater than physiological replacement doses of steroids.
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: Chris Fountain, RN 503-215-2691 christopher.fountain@providence.org
Contact: Brenda Fisher, RN 503-215-2613 brenda.fisher@providence.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02575404
Other Study ID Numbers  ICMJE 15-166
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Providence Health & Services
Study Sponsor  ICMJE Providence Health & Services
Collaborators  ICMJE Galectin Therapeutics Inc.
Investigators  ICMJE
Principal Investigator: Brendan Curti, MD Providence Health & Services
PRS Account Providence Health & Services
Verification Date October 2019

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