NCT02117362

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	1 mg/kg GR-MD-02	1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
BIOLOGICAL	2 mg/kg GR-MD-02	2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
BIOLOGICAL	4 mg/kg GR-MD-02	4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
BIOLOGICAL	8 mg/kg GR-MD-02	8 mg/mg GR-MD-02
BIOLOGICAL	Ipilimumab	3 mg/kg ipilimumab on Days 1, 22, 43, and 65

Timeline

• Start date: 2014-05-08
• Primary completion: 2018-11-28
• Completion: 2018-11-28
• First posted: 2014-04-17
• Last updated: 2019-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study