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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Patients will receive five doses of GR-MD-02 intravenously over 85 Days.
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.
Providence Cancer Center
Portland, Oregon, United States
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.
Time frame: 85 Days
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.
Time frame: Baseline and at Day 85
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
Time frame: 85 Days
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