NCT05913388

GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin-3 Inhibitor (GB1211) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.

Detailed description

Eligible patients will be registered, stratified by diagnosis (melanoma versus oral, head and neck (OHN) cancer), and the number of prior systemic therapies, and randomized to receive either GB1211 + pembrolizumab or pembrolizumab + placebo.

Conditions

• Metastatic Melanoma
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	GB1211	Administered orally twice daily at 100mg.
DRUG	Pembrolizumab	Administered at a fixed dose of 200 mg every 3 weeks intravenously.
DRUG	Placebo	Administered orally twice daily at 100mg.

Timeline

• Start date: 2024-02-29
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2023-06-22
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study