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

June 2, 2023 updated by: Providence Health & Services

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
85 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at Day 85
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
85 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence Health & Services

Collaborators

Galectin Therapeutics Inc.

Investigators

  • Principal Investigator: Brendan Curti, MD, Providence Health & Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2016

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

October 10, 2022

Study Registration Dates

First Submitted

October 9, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimated)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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