Who is eligible for clinical trial NCT05913388?

Participants must meet the protocol's inclusion criteria for Metastatic Melanoma. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05913388 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-07

GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma (NCT05913388)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Providence Health & Services

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (24 items).

Location: Providence Portland Medical Center — Portland, Oregon

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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):

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Providence Portland Medical Center — Portland, Oregon

📞 Contact the Study Coordinator

Phone: (503) 215-2691

Email: Christopher.Fountain@providence.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Metastatic Melanoma

ctDNA-guided Addition of Ipilimumab to Patients Receiving Nivolumab and Relatlimab — New York, New York
Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma — Boston, Massachusetts
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) — Orange City, Florida
Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies — Jacksonville, Florida
Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma — Toronto, Ontario

Explore by condition: All Metastatic Melanoma clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗