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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02575404
Recruitment Status : Active, not recruiting
First Posted : October 14, 2015
Last Update Posted : February 14, 2022
Sponsor:
Collaborator:
Galectin Therapeutics Inc.
Information provided by (Responsible Party):
Providence Health & Services

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Non-Small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Drug: GR-MD-02 Drug: Pembrolizumab Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : May 16, 2016
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 2 mg/kg GR-MD-02
2 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
 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
Experimental: 4 mg/kg GR-MD-02
4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
 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
Experimental: 8 mg/kg GR-MD-02
8 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
 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
Experimental: 4 mg/kg GR-MD-02 17 Cycles Maximum
4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment up to a maximum of 17 cycles.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT02575404


Locations
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United States, Oregon
Providence Cancer Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
Galectin Therapeutics Inc.
Investigators
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Principal Investigator: Brendan Curti, MD Providence Health & Services
More Information
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Additional Information:

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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02575404    
Other Study ID Numbers: 15-166
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Providence Health & Services:
Metastatic
Keytruda
pembrolizumab
 GR-MD-02
Galactoarabino-rhamnogalacturonate
Immunotherapy
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents