Back to resultsGR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients
Primary Purpose
Melanoma, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GR-MD-02
Pembrolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Metastatic, Keytruda, pembrolizumab, GR-MD-02, Galactoarabino-rhamnogalacturonate, Immunotherapy
Eligibility 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.
Sites / Locations
- Providence Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
2 mg/kg GR-MD-02
4 mg/kg GR-MD-02
8 mg/kg GR-MD-02
4 mg/kg GR-MD-02 17 Cycles Maximum
Arm Description
2 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
8 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment up to a maximum of 17 cycles.
Outcomes
Primary Outcome Measures
Frequency and Severity of Treatment-Related Adverse Events Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
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
Measure the response rate to combined therapy with GR-MD-02 and pembrolizumab in patients.
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.
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
Full Information
NCT ID
NCT02575404
First Posted
October 9, 2015
Last Updated
June 2, 2023
Sponsor
Providence Health & Services
Collaborators
Galectin Therapeutics Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02575404
Brief Title
GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 16, 2016 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
October 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services
Collaborators
Galectin Therapeutics Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
Keywords
Metastatic, Keytruda, pembrolizumab, GR-MD-02, Galactoarabino-rhamnogalacturonate, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 mg/kg GR-MD-02
Arm Type
Experimental
Arm Description
2 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
Arm Title
4 mg/kg GR-MD-02
Arm Type
Experimental
Arm Description
4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
Arm Title
8 mg/kg GR-MD-02
Arm Type
Experimental
Arm Description
8 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment.
Arm Title
4 mg/kg GR-MD-02 17 Cycles Maximum
Arm Type
Experimental
Arm Description
4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment up to a maximum of 17 cycles.
Intervention Type
Drug
Intervention Name(s)
GR-MD-02
Other Intervention Name(s)
Galactoarabino-rhamnogalactouronate
Intervention Description
Patients will receive five doses of GR-MD-02 intravenously over 85 Days.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency and Severity of Treatment-Related Adverse Events Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Description
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.
Time Frame
85 Days
Secondary Outcome Measure Information:
Title
Measure the response rate to combined therapy with GR-MD-02 and pembrolizumab in patients.
Description
Patients will have PET and CT scans at baseline and after 85 days to assess response to treatment.
Time Frame
Baseline and at Day 85
Title
Assess the biological activity of GR-MD-02 in combination with pembrolizumab.
Description
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
Time Frame
85 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Curti, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://oregon.providence.org/our-services/p/providence-cancer-center/
Description
Providence Cancer Center
Learn more about this trial
GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients
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