OncoMatch/Clinical Trials/NCT07276386
Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma
Is NCT07276386 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Melphalan/HDS (Percutaneous Hepatic Perfusion) and Tebentafusp for metastatic uveal melanoma.
Treatment: Melphalan/HDS (Percutaneous Hepatic Perfusion) · Tebentafusp — This Phase 2 study evaluates the efficacy and safety of sequential treatment with percutaneous hepatic perfusion (PHP) using melphalan/HDS followed by tebentafusp in patients with metastatic uveal melanoma (mUM) with isolated liver metastases. The rationale is that PHP enhances antigen release and immunomodulation, potentially sensitizing tumors to tebentafusp in HLA-A\*02:01-positive patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: HLA-A A*02:01 positive
HLA-A*02:01 positive status.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: PHP
Previous treatment with PHP
Cannot have received: tebentafusp
Previous treatment with tebentafusp
Lab requirements
Blood counts
Hemoglobin ≥90 g/L, platelets ≥100×10^9/L, neutrophils ≥1.5×10^9/L
Kidney function
Serum Creatinine <1.5×ULN and Creatinine Clearance ≥40 mL/min (Cockcroft and Gault formula)
Liver function
AST, ALT, bilirubin ≤2.5×ULN and PT-INR ≤1.5; no medical history of liver cirrhosis (Child-Pugh Class B or C) or evidence of portal hypertension
Cardiac function
No history of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes the use of general anesthesia
Reduced renal function defined as Serum Creatinine ≥1.5xULN or Creatinine Clearance < 40 mL/min, calculated using the Cockcroft and Gault formula. Reduced hepatic function (defined as AST, ALT, bilirubin>2.5*ULN and PT-INR>1.5) or medical history of liver cirrhosis (Child-Pugh Class B or C) or evidence of portal hypertension by history, endoscopy or radiology. Hemoglobin <90 g/L or platelets <100x10^9/L or neutrophils <1.5x10^9/L. History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes the use of general anesthesia.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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