RecruitingPhase 2NCT06070012

Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma

Phase II Open-label, Multi-center Study of Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (mUM) With Integrated Circulating Tumor DNA (ctDNA) Biomarker (TARGET-tebe)


Sponsor

Diwakar Davar

Enrollment

44 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A\*0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies tebentafusp, an immunotherapy drug, as a first-line treatment for metastatic uveal melanoma — a rare eye cancer that has spread to other parts of the body. This drug is designed to work specifically in patients with a particular immune system gene type. **You may be eligible if...** - You have metastatic uveal melanoma that has not been previously treated - You test positive for the HLA-A*0201 gene type (a specific immune marker) - You have measurable tumor on imaging - You are in good enough health to receive treatment **You may NOT be eligible if...** - You have received prior systemic therapy for metastatic uveal melanoma - You do not have the HLA-A*0201 gene type - You have active autoimmune disease - You have serious heart, liver, or other organ problems - You are pregnant or breastfeeding 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

An anti-cancer medication used to treat uveal melanoma. Tebentafusp is a bispecific gp100 peptide-HLA-directed CD3 T cell engager.


Locations(3)

University of Colorado Cancer Center

Aurora, Colorado, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06070012


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