Uveal MelanomaPhase 3ATOMNCT06246149
Adjuvant Tebentafusp in High Risk Ocular Melanoma
A Phase 3 study testing Tebentafusp in people with Uveal Melanoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Tebentafusp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 11 Nov 2024to Nov 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Show all 20Show fewer
- 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
Trial locations and contacts
15 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 9 countries
Germany3 sites, 3 recruiting
- Recruiting
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, 12200
- Recruiting
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Hamburg, 20246
- Recruiting
Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik
Heidelberg, DE 69120
France2 sites, 2 recruiting
- Recruiting
Centre Antoine Lacassagne
Nice, FR 06189
- Recruiting
Institut Curie - Hôpital de Paris
Paris, 75248
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Medical Centre
Leiden, 2300
- Recruiting
Erasmus MC
Rotterdam, NL 3015 GD
Spain2 sites, 2 recruiting
- Recruiting
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
L'Hospitalet de Llobregat, 08908
- Recruiting
Hospital Clinico Universitario De Valladolid
Valladolid, 47003
United Kingdom2 sites, 2 recruiting
- Recruiting
The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Liverpool
Liverpool, GB L7 8YA
- Recruiting
East and North Hertfordshire NHS Trust - Mount Vernon Hospital
Northwood, HA6 2RN
United States1 site, 1 recruiting
- Recruiting
Northwell Health -Center for Advanced Medicine
Lake Success, New York, 11042
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Poland1 site, 1 recruiting
- Recruiting
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 02 781
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, SE 413 45
About this study
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)
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.
- Conditions
- Uveal Melanoma
- Being tested
- Tebentafusp
- Keywords
- Tebentafusp, Adjuvant setting, Randomized phase III study, non-metastatic uveal melanoma
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TebentafuspDrug
Tebentafusp will be administered weekly i.v.
| Study group | Role | What they receive |
|---|---|---|
| Tebentafusp | Experimental | 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. Receives: Drug: Tebentafusp |
| Observation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-Free survival (RFS)
RFS is defined as the time between randomization and local recurrence, distant recurrence, or death, whichever occurs first
Measured: 8.1 years from first patient in
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as the time between randomization and death
Measured: 8.1 years from first patient in
Occurrence of Adverse Events
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting
Measured: 8.1 years from first patient in
Health-related Quality of Life
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
Measured: 8.1 years from first patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start11 Nov 2024
- Primary completionNov 2032 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Northwell Health, Immunocore Ltd
- Responsible party
- Sponsor
- Investigators
- Paul Nathan, Principal investigator, Mount Vernon Cancer Centre, Northwood, UKRichard D. Carvajal, Principal investigator, Northwell Health Cancer Institute, NY, USASerge Leyvraz, Principal investigator, Charité Hospital, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246149
- Sponsor's protocol ID
- EORTC-2022-MG
- Other IDs
- EU trial number
- Acronym
- ATOM
- Status last verified
- Jun 2026
- First submitted
- 30 Jan 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06246149
- Acronym / sponsor ID
- ATOM / EORTC-2022-MG
- Conditions
- Uveal Melanoma
- Keywords
- Tebentafusp, Adjuvant setting, Randomized phase III study, non-metastatic uveal melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Collaborators
- Northwell Health, Immunocore Ltd
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- Nov 2032 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tebentafusp | Experimental | Drug: TebentafuspParticipants 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. |
| Observation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TebentafuspTebentafusp will be administered weekly i.v. | Drug | Tebentafusp |
Primary outcome
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
3 secondary outcomes
Overall Survival (OS)
Time frame: 8.1 years from first patient in
Occurrence of Adverse Events
Time frame: 8.1 years from first patient in
Health-related Quality of Life
Time frame: 8.1 years from first patient in
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Related trials for Uveal Melanoma
RecruitingObservational study
High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes
Uveal Melanoma, High-risk Uveal Melanoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
RecruitingPhase 2
HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma（FASTIL-Mela02）
Melanoma (Excluding Uveal Melanoma)
Recruiting
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Uveal Melanoma
Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Choroidal Melanoma, Indeterminate Lesions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Nathan principal investigator
Mount Vernon Cancer Centre, Northwood, UK
Richard D. Carvajal principal investigator
Northwell Health Cancer Institute, NY, USA
Serge Leyvraz principal investigator
Charité Hospital, Berlin, Germany
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tebentafusp in people with Uveal Melanoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 15 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, France, Netherlands, Spain, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EORTC HQ (+32 2 774 16 11, eortc@eortc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-Free survival (RFS) (time frame: 8.1 years from first patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.