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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (2 UK sites)
The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Liverpool
Liverpool GB L7 8YA, United Kingdom
East and North Hertfordshire NHS Trust - Mount Vernon Hospital
Northwood HA6 2RN, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069How to Get in Touch
EORTC HQ
Sponsor contactCONTACT
