NCT04987996

GR-MD-02 + Pembrolizumab Versus Pembrolizumab Monotherapy in Melanoma and Squamous Cell Head and Neck Cancer Patients

Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin Inhibitor (GR-MD-02) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety \& efficacy of combination drugs versus placebo to treat metastatic melanoma and head and neck squamous cell carcinoma.

Detailed description

Eligible patients will be registered, stratified by diagnosis (melanoma versus OHN cancer), and the number of prior systemic therapies, and randomized to receive either GR-MD-02 + pembrolizumab or pembrolizumab + placebo. In addition to monitoring for toxicity and clinical response, blood and tumor samples will be obtained to assess immunologic measures relevant to galectin biology and pembrolizumab T-cell checkpoint inhibition.

Conditions

• Metastatic Melanoma
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	GR-MD-02	Patients will receive up to seventeen doses of GR-MD-02 intravenously over 85 Days.
DRUG	Placebo	Patients will receive up to seventeen doses of placebo intravenously over 85 Days.
DRUG	Pembrolizumab	Patients will receive 200mg doses of pembrolizumab intravenously over 85 Days.

Timeline

• Start date: 2023-07-01
• Primary completion: 2027-07-01
• Completion: 2031-07-01
• First posted: 2021-08-03
• Last updated: 2023-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study