Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

Adjuvant Tebentafusp in High Risk Ocular Melanoma

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

NCT ID: NCT06246149

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Tebentafusp (drug)
How long the study runs
Study runs about 96 months (dates as stated)
About the drug or intervention
Tebentafusp — drug: Tebentafusp will be administered weekly i.v.
Patient visit burden
Not specified by the sponsor

In plain English

This trial, run by the European Organisation for Research and Treatment of Cancer (EORTC), is looking at tebentafusp given after initial treatment for uveal melanoma (a rare eye cancer). It is for people whose cancer has not spread but who are at high risk of it coming back. Treatment details are not stated — ask the trial team.

Who can take part

  • Adults aged 18 or over with uveal melanoma (but not iris melanoma) that has not spread, already treated with surgery or radiotherapy
  • Joined within about 12 weeks of finishing that initial treatment, with no sign the cancer has come back on scans
  • At high risk of the cancer returning — either because of the cancer's stage or because of genetic test results (monosomy 3 or gene expression profile class 2)
  • Able to carry out normal daily activity with little or no limitation (performance status 0 or 1)
  • Tested positive for a marker called HLA-A*02:01
  • Healthy enough organs, based on blood tests
  • Not pregnant or breastfeeding, and willing to use very reliable contraception during treatment and for 6 months after the last dose
  • Able to give written informed consent

Who may not be able to

  • Serious or uncontrolled heart problems, including heart failure, uncontrolled high blood pressure, abnormal heart rhythm, a long QT interval on heart tracings, or a heart attack or unstable angina in the past 6 months
  • An active infection needing antibiotics (these must be finished at least a week before joining)
  • Severe or uncontrolled illness, including active hepatitis B or C, active HIV with more than 200 copies per ml of blood, bleeding disorders, or a kidney transplant (some people with past hepatitis B or C may still join if treated and the virus cannot be detected)
  • Another cancer, with some exceptions such as treated skin cancer, and some cancers treated more than 3 years ago that have not come back
  • An autoimmune disease needing immune-suppressing medicine in the past 2 years — though some conditions like well-controlled asthma, psoriasis, vitiligo, hair loss, stable thyroid or adrenal problems, or type 1 diabetes may be allowed
  • Anything (such as a personal, family or travel situation) that could make it hard to follow the trial schedule — this should be discussed with the trial team before joining
  • A known allergy or other reason someone cannot have the scans (MRI or CT) or contrast dyes used in the trial

What taking part involves

  • • Not stated — ask the trial team what treatment involves and how it is given

Time commitment: Not stated — ask the trial team about clinic visits, tests, and how long the trial lasts. Scans are needed before joining, and contraception (if relevant) is needed for 6 months after the last dose.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
290
Started
2024-11-11
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for uveal melanoma
  • • Phase3 - 290 participants
  • • At least 50% of patients with high-risk primary uveal melanoma will develop a recurrence following treatment of the primary tumour

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with uveal melanoma

Where?

  • • Liverpool - The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Liverpool
  • • Northwood - East and North Hertfordshire NHS Trust - Mount Vernon Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This 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.

Uveal Melanoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

Biomarkers mentioned

status or negative

Treatment history

Treatments you must have had:

  • ✓ baseline imaging performed within 4 weeks

What the study is looking for

  • ✓Primary non-that has spread 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...
  • ✓Fit enough for normal activity (ECOG 0) or 1
  • ✓18 years or older
  • ✓HLA-A\*02:01 positivity by local assessment

Who cannot take part

  • ✗Clinically significant heart disease or impaired heart function, including any of the following:
  • ✗QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs...
  • ✗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...
  • ✗Participant with history of HBC infection will be eligible the participant has received curative treatment and viral...
See the full criteria
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

Where Is This Study? (2 UK sites)

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

Liverpool GB L7 8YA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

East and North Hertfordshire NHS Trust - Mount Vernon Hospital

Northwood HA6 2RN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)

mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069

How to Get in Touch

EORTC HQ

Sponsor contact

CONTACT

+32 2 774 16 11 eortc@eortc.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-06