RecruitingPhase 3NCT06246149

Adjuvant Tebentafusp in High Risk Ocular Melanoma

Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*02:01 Positive Patients Following Definitive Treatment of High-risk Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial)


Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrollment

290 participants

Start Date

Nov 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

At least 50% of patients with high-risk primary uveal melanoma will develop a recurrence following treatment of the primary tumour. Observation is currently the standard of care in the non-metastatic setting. Tebentafusp is the first agent proven to improve overall survival in patients with metastatic uveal melanoma in a randomized trial. Based on the results in the advanced setting, it is hypothesized that treatment with tebentafusp may reduce the risk of development of disease recurrence.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing tebentafusp — an immunotherapy drug specifically designed to target a protein called gp100 found on uveal (eye) melanoma cells — as a preventive treatment after surgery or radiation for high-risk uveal melanoma to reduce the chance of cancer coming back. **You may be eligible if...** - You have uveal melanoma (melanoma of the eye, excluding iris melanoma) that has been treated with surgery or radiation but has not yet spread - Your treatment was completed within the past 11 weeks - Your tumor is considered high-risk: either stage III by standard staging, OR has specific genetic markers (monosomy 3 or GEP class 2) - You carry a specific immune marker called HLA-A*02:01 (a genetic type that allows tebentafusp to work) - You are 18 or older with good general health (ECOG 0 or 1) **You may NOT be eligible if...** - Your melanoma has already spread to other organs - You do not have the HLA-A*02:01 immune marker - You have active autoimmune disease requiring systemic treatment - You have had prior immunotherapy - Your performance status is poor 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

Tebentafusp will be administered weekly i.v.


Locations(14)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Centre Antoine Lacassagne

Nice, France

Institut Curie - Hôpital de Paris

Paris, France

Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, Germany

Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center

Hamburg, Germany

Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik

Heidelberg, Germany

Leiden University Medical Centre

Leiden, Netherlands

Erasmus MC

Rotterdam, Netherlands

Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)

L'Hospitalet de Llobregat, Spain

Hospital Clinico Universitario De Valladolid

Valladolid, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Liverpool

Liverpool, United Kingdom

East and North Hertfordshire NHS Trust - Mount Vernon Hospital

Northwood, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06246149


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