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.
Treatment: GB1211 · Pembrolizumab — 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.
Check if I qualifyExtracted 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
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