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.

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 who have radiographic progression using Response Evaluation Criteria In Solid Tumors (RECIST) currently on pembrolizumab are also eligible.

Exclusion Criteria:
• 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.
Phase Ib
Cutaneous (skin)
Brendan Curti, M.D.
Earle A Chiles Research Institute (EACRI)
Chris Fountain
  • Providence Cancer Institute Franz Clinic