Adjuvant Tebentafusp in High Risk Ocular Melanoma (ATOM)

June 29, 2026 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc
        • Contact:
          • Jean-Francois Baurain
  • France
      • Nice, France, FR 06189
        • Recruiting
        • Centre Antoine Lacassagne
        • Contact:
          • Agnes Ducoulombier
      • Paris, France, 75248
        • Recruiting
        • Institut Curie - Hopital de Paris
        • Contact:
          • Manuel RODRIGUES
  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
        • Contact:
          • Caroline Anna Peuker
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
        • Contact:
          • Christoffer Gebhardt
      • Heidelberg, Germany, DE 69120
        • Recruiting
        • Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik
        • Contact:
  • Netherlands
      • Leiden, Netherlands, 2300
        • Recruiting
        • Leiden University Medical Centre
        • Contact:
          • Ellen Kapiteijn
      • Rotterdam, Netherlands, NL 3015 GD
        • Recruiting
        • Erasmus MC
        • Contact:
          • Astrid van der Veldt
  • Poland
      • Warsaw, Poland, 02 781
        • Recruiting
        • Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
        • Contact:
          • Piotr Rutkowski
  • Spain
      • L'Hospitalet de Llobregat, Spain, 08908
        • Recruiting
        • Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
        • Contact:
          • Josep Piulats Rodriguez
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
          • Lopez Castro Rafael
  • Sweden
      • Gothenburg, Sweden, SE 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
        • Contact:
          • Lars Ny
  • United Kingdom
      • Liverpool, United Kingdom, GB L7 8YA
        • Recruiting
        • The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Liverpool
        • Contact:
          • Joseph Sacco
      • Northwood, United Kingdom, HA6 2RN
        • Recruiting
        • East and North Hertfordshire NHS Trust - Mount Vernon Hospital
        • Contact:
          • Paul Nathan, Pr
  • United States
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Northwell Health -Center for Advanced Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy
  • Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks )
  • High-risk according to either 1) clinical criteria: TNM (AJCC8) stage III or 2) genetic criteria: monosomy 3 or GEP class 2. Prior to enrolment of the first patient, each site will declare which of the two genetic criteria it uses. Patients with stage I and stage II are only eligible if they meet the genetic criterion declared by the site.
  • ECOG performance status of 0 or 1
  • 18 years or older
  • HLA-A*02:01 positivity by local assessment
  • No evidence of UM recurrence, as evidenced by the required baseline imaging performed within 4 weeks prior to randomization
  • Adequate organ function
  • Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.
  • For patients of childbearing / reproductive potential, agreement to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
  • For female subjects who are breast feeding, agreement to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.
  • Written informed consent according to ICH/GCP and local regulations

Exclusion Criteria:

  • Clinically significant cardiac disease or impaired cardiac function, including any of the following:
  • Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment
  • QTcF > 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs obtained over a brief time interval (i.e., within 30 minutes)
  • Acute myocardial infarction or unstable angina pectoris < 6 months prior to screening
  • Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to randomization
  • Any evidence of severe or uncontrolled systemic disease or active infection including hepatitis B, hepatitis C and known active human immunodeficiency virus (HIV) defined as >200 copies of HIV per ml of blood, active bleeding diatheses or renal transplant. NOTE: testing for HIV, HBV, and HCV status prior to enrolment is not necessary unless clinically indicated.
  • Participant with history of HBV infection will be eligible if on stable anti-viral therapy for > 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable during Screening.
  • Participant with history of HBC infection will be eligible the participant has received curative treatment and viral load was confirmed as undetectable during Screening.
  • History of another primary malignancy except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and with the following exception. Patients with a history of another primary cancer treated with curative intent more than 3 years before study entry, who are not receiving any anti-cancer therapy, have a risk of disease recurrence lower than 10% as evaluated by the local Investigator, and who have no toxicity from previous treatment are eligible.
  • Participants with active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn's disease), within 2 years of screening. NOTE: The following exceptions are permitted:
  • Vitiligo
  • Alopecia
  • Managed hypothyroidism (on stable replacement doses)
  • Asymptomatic adrenal insufficiency (on stable replacement doses)
  • Psoriasis
  • Resolved childhood asthma/atopy
  • Well-controlled asthma
  • Type I diabetes mellitus
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.
  • Known contraindication to imaging tracer or any product of contrast media and MRI and/or CT contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Experimental: Tebentafusp
Participants will receive tebentafusp 20 mcg on week 1, 30 mcg on week 2, 68 mcg on week 3, and 68 mcg weekly thereafter for 6 months i.e., maximum 26 infusions.
Drug: Tebentafusp
Tebentafusp will be administered weekly i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free survival (RFS)
Time Frame: 8.1 years from first patient in
RFS is defined as the time between randomization and local recurrence, distant recurrence, or death, whichever occurs first
8.1 years from first patient in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 8.1 years from first patient in
OS is defined as the time between randomization and death
8.1 years from first patient in
Occurrence of Adverse Events
Time Frame: 8.1 years from first patient in
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting
8.1 years from first patient in
Health-related Quality of Life
Time Frame: 8.1 years from first patient in
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
8.1 years from first patient in

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Northwell Health
Immunocore Ltd

Investigators

  • Principal Investigator: Paul Nathan, Mount Vernon Cancer Centre, Northwood, UK
  • Principal Investigator: Richard D. Carvajal, Northwell Health Cancer Institute, NY, USA
  • Principal Investigator: Serge Leyvraz, Charité Hospital, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

November 1, 2032

Study Completion (Estimated)

November 1, 2032

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-2022-MG
  • EU trial Number (Other Identifier: 2022-502339-20-00)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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