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RECRUITING
NCT06246149
PHASE3

Adjuvant Tebentafusp in High Risk Ocular Melanoma

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2024-11-11

Completion Date

2032-11

Last Updated

2026-03-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tebentafusp

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