RecruitingPhase 2NCT06414590

Neoadjuvant Tebentafusp for Uveal Melanoma

Neoadjuvant Tebentafusp in Patients With Locally Advanced, Unresectable Primary Uveal Melanoma


Sponsor

Thomas Jefferson University

Enrollment

19 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests tebentafusp — a targeted immunotherapy drug — given before surgery (as neoadjuvant treatment) for uveal melanoma, a rare type of eye cancer (melanoma of the eye). The drug specifically targets a protein called gp100, which is found on uveal melanoma cells, and requires a specific immune gene (HLA-A*02:01) to work. **You may be eligible if...** - You are 18 or older with a primary uveal melanoma (eye melanoma) - Your tumor is large (T3 or T4 category) and cannot be surgically removed without removing the entire eye - You have not yet received any treatment for this cancer - You carry the HLA-A*02:01 immune marker (a genetic test is required) - You are willing to have tumor biopsies **You may NOT be eligible if...** - You do not carry the HLA-A*02:01 genetic marker - You have already received treatment for uveal melanoma - Your tumor could be removed with surgery that preserves the eye - Your expected survival is less than 12 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTebentafusp-Tebn

Tebentafusp will be administered as follows: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter.


Locations(2)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

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NCT06414590