RecruitingPhase 2NCT06942442

A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma


Sponsor

Sarcoma Alliance for Research through Collaboration

Enrollment

47 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, open label, phase II study of tebentafusp in patients with unresectable or metastatic clear cell sarcoma (CCS).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial is testing tebentafusp, an immunotherapy drug, in patients with advanced clear cell sarcoma — a rare soft tissue cancer — who carry a specific immune marker called HLA-A*02:01. **You may be eligible if...** - You are 18 or older - You have confirmed unresectable or metastatic clear cell sarcoma (a type of soft tissue cancer) - You test positive for HLA-A*02:01 (a specific genetic immune marker) - You have measurable disease on CT or MRI scans - Your performance status is ECOG 2 or better - Your organ function (blood counts, liver, kidney) meets the required levels **You may NOT be eligible if...** - Your tumor is HLA-A*02:01-negative - Your cancer is not the clear cell sarcoma subtype - You have severe organ dysfunction - 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

DRUGPhysician's Choice

Patients who are HLA-A\*02:01-negative and ineligible to receive tebentafusp will be prospectively enrolled onto a separate study arm and treated with physicians' choice of treatment. They will also be radiographically assessed at the same schedule as patients treated with tebentafusp, if feasible, and kept on this treatment arm until progression of disease or unacceptable toxicity on the physicians' choice regimen.

DRUGTebentafusp

Patients who screen positive for HLA-A\*02:01 and meet the eligibility requirements will be treated with weekly tebentafusp


Locations(2)

University of Southern California - Norris Cancer Center

Los Angeles, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT06942442


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