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Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma

Metastatic Melanoma Clinical Trial

Official title:
Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma

Clinical Trial Summary

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.

Clinical Trial 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 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02117362
Study type Interventional
Source Providence Health & Services
Contact
Status Completed
Phase Phase 1
Start date May 8, 2014
Completion date November 28, 2018
View Details
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