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GB1211 and Pembrolizumab for Metastatic Melanoma and Head and Neck Cancer

This study is looking at how well a combination of two drugs, GB1211 and pembrolizumab, works compared to pembrolizumab and a placebo (an inactive pill) for people with advanced metastatic melanoma or head and neck squamous cell carcinoma (a type of cancer that starts in the moist linings of the body, like the mouth or throat). Researchers want to see if this drug combination can shrink tumors or stop them from growing. You could be eligible if you are an adult with unresectable (cannot be removed by surgery) or metastatic melanoma, or head and neck squamous cell carcinoma that has progressed after chemotherapy. The study aims to enroll 92 participants, but its current status is unclear.

Study design
This is an interventional study where participants will be randomly assigned to receive either GB1211 plus pembrolizumab or pembrolizumab plus a placebo. It plans to enroll 92 participants.
What's involved
Participants will receive GB1211 or placebo orally twice daily, and pembrolizumab intravenously every 3 weeks. The overall response rate will be assessed through imaging for up to 63 weeks.
Compensation
Not stated in the trial record.
Follow-up
Overall response rate will be measured from the date of randomization until the date of first documented progression, assessed up to 63 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05913388

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Providence Health & Services
~92 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:GB1211PembrolizumabPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate based on disease imaging
Measured over From the date of randomization until the date of first documented progression, assessed up to 63 weeks.

Conditions

Metastatic Melanoma
Head and Neck Squamous Cell Carcinoma

Explore related trials

Head and Neck Squamous Cell CarcinomaMelanoma

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

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

Who to contact

Chris Fountain, RN, ONC
[email protected]
503-215-2691
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas. Histological confirmation of melanoma will be required by previous biopsy or cytology. Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy are eligible. PD-L1 testing is not needed for OHN cancers.
Patients who have received anti-PD1 or anti-PD-L1 in the past are eligible if it has been at least 6 months since the last anti-PD-1 or PD-L1 dose, they meet all other eligibility criteria and progression of malignancy has been documented on imaging. Progression for this patient subset is defined as the appearance of one or more new metastatic sites, or a 5% or greater increase in the sum of diameter of target lesions or an unequivocal increase in non-target site. Treatment naïve melanoma patients are eligible.
Patients must be ≥ 18 years of age.
ECOG performance status of 0-2.
Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
No active bleeding.
Anticipated lifespan greater than 12 weeks.
Patients must sign a study-specific consent document.

Exclusion

Patients who have previously received a galectin antagonist.
Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo.
Patients with history of autoimmune colitis.
Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
Patients requiring other systemic oncologic therapy, including experimental therapies.
Patients who have received anti-cancer treatment within 3 weeks or 5 half-lives before first study drug dose.
Patients with Child-Pugh C hepatic impairment.
Patients with active infection requiring antibiotics.
Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
Need for steroids at greater than physiologic replacement doses. Inhaled corticosteroids are acceptable.
Laboratory exclusions (to be performed within 28 days of enrollment):
WBC \< 3.0 x 109/L
Hgb \< 9.0 g/dL
AST or ALT \> 1.5 times ULN
Total bilirubin \> 1.9 g/dL, unless due to Gilbert's Syndrome. If Gilbert's Syndrome is present by clinical history, then direct bilirubin must by \< 3.0 g/dl.
Active or known history of HIV
Active or known history of Hepatitis B
Active or known history of Hepatitis C
Platelet counts \< 100 x 10E9 / L (100,000/ μL) without transfusion
INR \> 1.5x ULN
Inability to give informed consent and comply with the protocol. Patients must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures.
Unresolved immune-mediated pneumonitis, diarrhea, elevation of hepatocellular enzymes or other toxicities requiring greater than physiological replacement doses of steroids.

What this trial measures

  • Overall response rate based on disease imagingFrom the date of randomization until the date of first documented progression, assessed up to 63 weeks.

    Determine the response of Gal-3 inhibitor and pembrolizumab versus pembrolizumab monotherapy (plus placebo) in patients with metastatic melanoma or head and neck squamous cell carcinoma (HNSCC).