Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma (NCT06627244) | Clinical Trial Compass
RecruitingPhase 2
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
United States30 participantsStarted 2025-02-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review
✓. Serum bilirubin \<2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN)
✓. Mapping angiogram procedure shows radioembolization is feasible and safe to perform
✓. Human leukocyte antigen-A\*02:01(HLA A⁕ 02:01) positive
✓. Patient age ≥ 18 years old
✓. Ability to provide and understand written informed consent
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓. Patients must have measurable disease or non-measurable disease according to RECIST 1.1 (Eisenhauer et al, 2009).
Exclusion criteria
✕. Patient with any tumor size \> 8 cm
✕. 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
✕. Clinical laboratory measurements that meet any of the following criteria:
✕. Angiogram shows vascular shunting which prevents radioembolization
✕. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: Up to 24 months
2
Number of Participants Experiencing Treatment-Related Adverse Events
✕. Patients with clinically significant cardiac disease or impaired cardiac function, including any of the following:
✕. Presence of symptomatic or untreated central nervous system (CNS) metastases or CNS metastases that require doses of corticosteroids within 14 days prior to study treatment Day 1.
✕. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of Tebentafusp.