OncoMatch

OncoMatch/Clinical Trials/NCT05913388

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

Is NCT05913388 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including GB1211 and Pembrolizumab for metastatic melanoma.

Phase 2RecruitingProvidence Health & ServicesNCT05913388Data as of May 2026

Treatment: GB1211 · PembrolizumabThe 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.

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Extracted eligibility criteria

Cancer type

Melanoma

Head and Neck Squamous Cell Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: platinum-based chemotherapy — HNSCC

disease progression during or after platinum-containing chemotherapy

Cannot have received: galectin antagonist

Patients who have previously received a galectin antagonist

Lab requirements

Blood counts

WBC < 3.0 x 10^9/L; Hgb < 9.0 g/dL; Platelet counts < 100 x 10E9 / L (100,000/ μL) without transfusion; INR > 1.5x ULN

Liver function

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. Patients with Child-Pugh C hepatic impairment [excluded].

Laboratory exclusions: WBC < 3.0 x 10^9/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. Platelet counts < 100 x 10E9 / L (100,000/ μL) without transfusion; INR > 1.5x ULN. Patients with Child-Pugh C hepatic impairment [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Providence Portland Medical Center · Portland, Oregon

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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