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

Locally Advanced Unresectable Uveal Melanoma

Summary

This phase II trial tests how well tebentafusp works to shrink tumors prior to primary treatment with surgery or radiation in patients with uveal (eye) melanoma that has spread to nearby tissue or lymph nodes (locally advanced) or that cannot be removed by surgery (unresectable). Tebentafusp is a drug that binds to melanoma tumor cells as well as immune cells called T-cells. This binding causes an immune response against the melanoma cells, which leads to tumor cell death. Tebentafusp has been approved for the treatment of locally advanced and unresectable uveal melanoma. Giving tebentafusp before primary treatment with surgery or radiation may help shrink the tumor, prevent the disease from spreading, or reduce the likelihood that patients will require total eye removal (called enucleation).

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 is a simplified summary. 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

View Full Details on ClinicalTrials.gov

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NCT06414590