Actively Recruiting
GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma
Led by Providence Health & Services · Updated on 2026-04-13
92
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
Sponsors
P
Providence Health & Services
Lead Sponsor
P
Providence Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas confirmed by biopsy or cytology
- Patients with recurrent or metastatic head and neck squamous cell carcinoma with progression during or after platinum-containing chemotherapy
- Patients who received anti-PD1 or anti-PD-L1 at least 6 months ago with documented progression on imaging
- Treatment-naïve melanoma patients are eligible
- Age 18 years or older
- ECOG performance status of 0 to 2
- Women of childbearing potential must have a negative pregnancy test within 72 hours before treatment and agree to use birth control
- No active bleeding
- Anticipated lifespan longer than 12 weeks
- Signed study-specific consent
You will not qualify if you...
- Previous treatment with a galectin antagonist
- Active autoimmune disease except autoimmune thyroiditis or vitiligo
- History of autoimmune colitis
- Untreated brain metastases; treated brain metastases must be controlled with follow-up imaging 4 or more weeks after therapy
- Need for systemic oncologic therapy other than study drugs
- Anti-cancer treatment within 3 weeks or 5 half-lives before first study drug dose
- Child-Pugh C hepatic impairment
- Active infection requiring antibiotics
- Pregnant or lactating women
- Need for steroids above physiologic replacement doses (inhaled corticosteroids allowed)
- Laboratory abnormalities within 28 days: WBC < 3.0 x 10^9/L, Hgb < 9.0 g/dL, AST or ALT > 1.5 times upper limit, total bilirubin > 1.9 g/dL unless Gilbert's Syndrome, platelet count < 100,000/µL without transfusion, INR > 1.5 times upper limit
- Active or known history of HIV, Hepatitis B, or Hepatitis C
- Unable to give informed consent or comply with study procedures
- Any medical condition that may compromise safety or study conduct
- Unresolved immune-related toxicities requiring steroids above physiologic doses
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
Research Team
C
Chris Fountain, RN, ONC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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