NCT06627244 Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
| NCT ID | NCT06627244 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Miami |
| Condition | Metastatic Uveal Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2028-02-17 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The 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.
Eligibility Criteria
Inclusion Criteria: 1. Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review 2. Serum bilirubin \<2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN) 3. Mapping angiogram procedure shows radioembolization is feasible and safe to perform 4. Human leukocyte antigen-A\*02:01(HLA A⁕ 02:01) positive 5. Patient age ≥ 18 years old 6. Ability to provide and understand written informed consent 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 8. Patients must have measurable disease or non-measurable disease according to RECIST 1.1 (Eisenhauer et al, 2009). Exclusion Criteria: 1. Patient with any tumor size \> 8 cm 2. 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 3. Clinical laboratory measurements that meet any of the following criteria: * Alanine aminotransferase (ALT)
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