Neoadjuvant Tebentafusp for Uveal Melanoma (NCT06414590) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Tebentafusp for Uveal Melanoma
United States19 participantsStarted 2025-09-05
Plain-language summary
This is a prospective, single arm, phase II clinical trial of neoadjuvant Tebentafusp (KIMMTRAK®) in patients with locally advanced primary uveal melanoma. Patients must be HLA-A\*02:01 with large, surgically unresectable (other than complete enucleation of the eye) primary uveal melanoma. The efficacy of this treatment will be assessed with the Simon's two stage design. The choice of design is guided by a desire to stop the trial early if the actual regression rate of primary uveal melanoma is 1% or lower.
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
. Male or female patient age ≥ 18 years of age at the time of informed consent.
. Ability to provide and understand written informed consent prior to any study procedures.
. Willingness to undergo tumor biopsies at baseline and post-Tebentafusp treatment.
. Treatment naïve primary uveal melanoma with T3 or T4 category tumor size that are surgically unresectable (other than complete enucleation of eye).
. No surgical indication to completely remove the tumor without enucleation.
. Clinically or cytologically confirmed primary uveal melanoma.
. Participants must be HLA-A\*02:01 positive.
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
Regression of primary uveal melanoma after Tebentafusp treatment in 20% of treated patients.
. Predicted life expectancy of at least 12 weeks as estimated by investigator
Exclusion criteria
. Symptomatic uveal melanoma that requires immediate ophthalmological intervention such as enucleation.
. Evidence of metastatic disease.
. Previous treatment with Tebentafusp.
. Patients with any out-of-range laboratory values defined as:
. History of severe hypersensitivity reactions (e.g., anaphylaxis) to other biologic drugs or monoclonal antibodies.
. Clinically significant cardiac disease or impaired cardiac function, including any of the following:
. 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 study drug.
. Participants with a history of human immunodeficiency virus (HIV) infection. NOTE: Testing is not required unless mandated by the local health authority. Participants with HIV infection may be eligible if ALL of the following are applicable: