OncoMatch/Clinical Trials/NCT06797297
A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy
Is NCT06797297 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including IBI363 and Pembrolizumab for melanoma.
Treatment: IBI363 · Pembrolizumab — This is a Phase II, open-label, randomized, multi-center study to assess the efficacy and safety of IBI363 monotherapy compared to Pembrolizumab in the treatment of patients with unresectable locally advanced or metastatic mucosal or acral melanoma who had not previously received systemic therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Hemoglobin ≥90 g/L; ANC ≥1.5×10^9/L; Platelet count ≥100×10^9/L
Kidney function
Serum creatinine ≤1.5×ULN or CCr ≥45 mL/min (Cockcroft-Gault formula, actual body weight)
Liver function
Total bilirubin ≤1.5× ULN; AST/ALT ≤3×ULN (≤5×ULN with liver metastasis); Albumin ≥30 g/L
Any of the following hematological abnormalities were present at baseline: Hemoglobin <90 g/L; ANC <1.5×10^9/L; Platelet count <100×10^9/L. Any of the following serum biochemical abnormalities are present at baseline: Total bilirubin >1.5× ULN; AST or ALT >3×ULN; For liver metastasis, AST or ALT > 5.0×ULN; Serum Creatinine >1.5×ULN or CCr <45 mL/min. Albumin <30 g/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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