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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: Up to 24 months
2
Number of Participants Experiencing Treatment-Related Adverse Events
. 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
. 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.