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OncoMatch/Clinical Trials/NCT06627244

Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma

Is NCT06627244 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tebentafusp for metastatic uveal melanoma.

Phase 2RecruitingUniversity of MiamiNCT06627244Data as of May 2026

Treatment: TebentafuspThe purpose of this study is to determine the effects (good and bad) that Tebentafusp in combination with Yttrium-90 (Y-90) radioembolization has on patients with metastatic uveal melanoma that has spread to the liver.

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Extracted eligibility criteria

Cancer type

Melanoma

Biomarker criteria

Required: HLA-A A*02:01 positive

Human leukocyte antigen-A*02:01(HLA A⁕ 02:01) positive

Disease stage

Required: Stage IV

Metastatic disease required

Metastatic uveal melanoma, confined mainly to the liver

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: radioembolization or other regional, liver-directed therapy

Lab requirements

Blood counts

Absolute neutrophil count (ANC) < 1.0 × 10^9 cells/L; Absolute lymphocyte count < 0.5 × 10^9 cells/L; Platelet count < 75 × 10^9 platelets/L; Hemoglobin < 8 g/dL

Liver function

Serum bilirubin <2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x upper limit of normal (ULN); Exclusion: Total bilirubin > 1.5 × ULN, except for patients with Gilbert's syndrome, who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN; ALT > 3 × ULN; AST > 3 × ULN

Cardiac function

Clinically significant cardiac disease or impaired cardiac function, including: congestive heart failure (NYHA Class ≥ 3), uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 110 mmHg), history of ventricular arrhythmia currently requiring medical treatment, uncontrolled atrial fibrillation, ECG QTcF > 470 msec or known history of congenital prolonged QT syndrome, acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to screening

Serum bilirubin <2 mg/dl, AST and ALT < 5 x ULN; Exclusion: Total bilirubin > 1.5 × ULN, except for patients with Gilbert's syndrome, who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN; ALT > 3 × ULN; AST > 3 × ULN; ANC < 1.0 × 10^9 cells/L; Absolute lymphocyte count < 0.5 × 10^9 cells/L; Platelet count < 75 × 10^9 platelets/L; Hemoglobin < 8 g/dL; Cardiac disease as detailed

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

US trial sites

  • University of Miami · Miami, Florida

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