RecruitingPhase 2NCT05913388

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


Sponsor

Providence Health & Services

Enrollment

92 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding GB1211 (a drug that blocks adenosine, a molecule that can help tumors hide from the immune system) to the immunotherapy drug pembrolizumab improves outcomes for people with advanced melanoma or head and neck cancer. **You may be eligible if...** - You have unresectable or metastatic melanoma (including rare types like mucosal melanoma) - Or you have recurrent or metastatic head and neck squamous cell carcinoma - You have not been previously treated with pembrolizumab or similar immunotherapy for advanced disease - You have good general health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to the brain (unless stable and not requiring treatment) - You have active autoimmune disease requiring medication - You have had a liver transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGB1211

Administered orally twice daily at 100mg.

DRUGPembrolizumab

Administered at a fixed dose of 200 mg every 3 weeks intravenously.

DRUGPlacebo

Administered orally twice daily at 100mg.


Locations(1)

Providence Portland Medical Center

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

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NCT05913388


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