The purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.
Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas. Histological confirmation of melanoma will be required by previous biopsy or cytology. Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy are eligible. PD-L1 testing is not needed for OHN cancers.
Patients who have received anti-PD1 or anti-PD-L1 in the past are eligible if it has been at least 6 months since the last anti-PD-1 or PD-L1 dose, they meet all other eligibility criteria and progression of malignancy has been documented on imaging. Progression for this patient subset is defined as the appearance of one or more new metastatic sites, or a 5% or greater increase in the sum of diameter of target lesions or an unequivocal increase in non-target site. Treatment naïve melanoma patients are eligible.
Patients must be ≥ 18 years of age.
ECOG performance status of 0-2.
Patients who have previously received a galectin antagonist.
Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo.
Patients with history of autoimmune 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.
Parallel
GB1211
DrugAdministered orally twice daily at 100mg.
Pembrolizumab
DrugAdministered at a fixed dose of 200 mg every 3 weeks intravenously.
Placebo
DrugAdministered orally twice daily at 100mg.
Overall response rate based on disease imaging
Determine the response of Gal-3 inhibitor and pembrolizumab versus pembrolizumab monotherapy (plus placebo) in patients with metastatic melanoma or head and neck squamous cell carcinoma (HNSCC).
Evaluation of GAL-3 Expression
Compare Gal-3 expression in paired biopsies after GB1211 + pembrolizumab or pembrolizumab monotherapy
Evaluation of Predictive Biomarker
Characterize myeloid-derived suppressor cells (MDSC) expression over time as a predictive biomarker of response after GB1211 + pembrolizumab or pembrolizumab monotherapy
Frequency of Immune-mediated Adverse Events
Compare the frequency of immune-mediated adverse events after GB1211 + pembrolizumab versus pembrolizumab + placebo
Evaluation of Antiviral Immunity
Assess the biological activity of GB1211 + pembrolizumab and in comparison to pembrolizumab monotherapy by measuring CD4+T cells with a memory phenotype (CD3+CD4+Ki67+CD25+FoxP3-CCR7-CD45RA-CD27+CD28+/-).
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Providence Health & Services
Lead sponsor
Providence Cancer Center
Collaborator
Providence Cancer Center, Earle A. Chiles Research Institute
Collaborator
Galecto Biotech AB
Collaborator
