Actively Recruiting
Adjuvant Tebentafusp in High Risk Ocular Melanoma
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-03-04
290
Participants Needed
14
Research Sites
416 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
N
Northwell Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Adjuvant Tebentafusp in High Risk Ocular Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary non-metastatic uveal melanoma (excluding iris melanoma) after definitive treatment by surgery or radiotherapy
- Time from primary treatment to randomization no longer than 12 weeks
- High-risk disease defined by either TNM stage III or genetic criteria (monosomy 3 or GEP class 2) as declared by the site
- ECOG performance status of 0 or 1
- Age 18 years or older
- Positive HLA-A*02:01 status by local testing
- No evidence of uveal melanoma recurrence confirmed by baseline imaging within 4 weeks prior to randomization
- Adequate organ function
- Women of childbearing potential must have a negative pregnancy test within 3 days prior to randomization and agree to use effective birth control during treatment and for 6 months after
- Breastfeeding women must agree to stop nursing prior to treatment and for 6 months after
- Provide written informed consent according to regulations
You will not qualify if you...
- Significant or uncontrolled heart disease including congestive heart failure (NYHA grade 2 or higher), uncontrolled hypertension, or arrhythmia requiring treatment
- QTcF interval over 470 msec or congenital long QT syndrome
- Myocardial infarction or unstable angina within 6 months before screening
- Active infection requiring systemic antibiotics or ongoing infection including hepatitis B, hepatitis C, or active HIV infection
- Severe or uncontrolled systemic disease or active infection
- History of HBV or HCV infection only if not adequately treated or viral load not undetectable
- History of other primary cancers unless treated curatively over 3 years ago with low recurrence risk and no ongoing treatment or toxicity
- Active autoimmune disease requiring immunosuppressive therapy within 2 years, except for certain allowed conditions such as vitiligo, alopecia, managed hypothyroidism, asymptomatic adrenal insufficiency, psoriasis, resolved childhood asthma, well-controlled asthma, or type I diabetes
- Any psychological, social, or geographical condition that may interfere with study compliance
- Known contraindications to imaging contrast agents or MRI/CT contraindications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
2
Centre Antoine Lacassagne
Nice, France, FR 06189
Actively Recruiting
3
Institut Curie - Hôpital de Paris
Paris, France, 75248
Actively Recruiting
4
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, 12200
Actively Recruiting
5
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Hamburg, Germany, 20246
Actively Recruiting
6
Universitaetsklinikum Heidelberg - Frauenklinik / Hautklinik
Heidelberg, Germany, DE 69120
Actively Recruiting
7
Leiden University Medical Centre
Leiden, Netherlands, 2300
Actively Recruiting
8
Erasmus MC
Rotterdam, Netherlands, NL 3015 GD
Actively Recruiting
9
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland, 02 781
Actively Recruiting
10
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
11
Hospital Clinico Universitario De Valladolid
Valladolid, Spain, 47003
Actively Recruiting
12
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, SE 413 45
Actively Recruiting
13
The Clatterbridge cancer Center NHS foundation Trust - Clatterbridge Cancer Center - Liverpool
Liverpool, United Kingdom, GB L7 8YA
Actively Recruiting
14
East and North Hertfordshire NHS Trust - Mount Vernon Hospital
Northwood, United Kingdom, HA6 2RN
Actively Recruiting
Research Team
E
EORTC HQ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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