Adjuvant Tebentafusp for High-Risk Ocular Melanoma
This study is testing a drug called tebentafusp for people with high-risk uveal melanoma (a type of eye cancer) that has not spread. After your primary treatment (surgery or radiation), if you are considered high-risk based on clinical or genetic factors, you might be able to join. Tebentafusp is given weekly through an IV. We want to see if tebentafusp can prevent the cancer from coming back (recurrence-free survival). This drug has already been shown to help people with uveal melanoma that has spread. The study plans to enroll 290 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 290 participants. The phase of the study is not specified.
- What's involved
- Tebentafusp will be administered weekly intravenously (i.v.).
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for recurrence-free survival, measured at 8.1 years from the first patient enrolled.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06246149
Adjuvant Tebentafusp in High Risk Ocular Melanoma
Recruiting
PHASE3Ages 18+InterventionalTreatmentEuropean Organisation for Research and Treatment of Cancer - EORTCGovernment-funded
~290 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Tebentafusp
At a glance
Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence-Free survival (RFS)
Measured over 8.1 years from first patient in
Conditions
Where it's being run
15 sites across 9 statesGermany3
France2
Netherlands2
Spain2
United Kingdom2
New York1
Belgium1
Poland1
Study leadership
- 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
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Recurrence-Free survival (RFS)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