RWF_14-004

Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients with Metastatic Melanoma

The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02 is a galectin. Galectins are a family of proteins that have numerous functions in normal mammalian biology including the facilitation of cell-cell interactions, regulation of cell-death and regulation of immune system responses. The hypothesis is that a safe dose of GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found. 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 ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. In addition to monitoring for toxicity and clinical response, blood samples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition.

Inclusion Criteria:

* Patients with metastatic or unresectable melanoma for whom treatment with ipilimumab is indicated. Histological confirmation of melanoma will be required by previous biopsy or cytology.

* ECOG performance status of 0-1.

* No active bleeding.


Exclusion Criteria:

* Patients who have previously received a galectin antagonist

* Prior ipilimumab to treat metastatic melanoma (prior ipilimumab in the adjuvant setting is permitted if the patient did not experience ≥ grade 3 toxicity related to immunotherapy).

* Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo.

* Patients with history of colitis
Phase I
NCT02117362
Cancer, All Other
Cutaneous (skin), Melanoma
Brendan Curti, M.D.
Earle A Chiles Research Institute (EACRI)
Chris Fountain
  • Oncology and Hematology Care Eastside