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

NCT05913388 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Providence Cancer Center

    collaborator UNKNOWN

  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER

  • Galecto Biotech AB

    collaborator INDUSTRY

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Brendan D. Curti, MD · Providence Health & Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2028-02-29
Completion
2030-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05913388 on ClinicalTrials.gov