Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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
Qualifiers
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
Disqualifiers
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
Alanine aminotransferase (ALT) > 3 × ULN
Aspartate aminotransferase (AST) > 3 × ULN
Trial design
Treatments tested in this trial
- Tebentafusp
- TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Miami
Lead sponsor
Immunocore Ltd
Collaborator
Source ClinicalTrials.gov