Actively Recruiting
Adjuvant Tebentafusp Versus Observation in HLA-A*02:01 Positive Patients After Treatment of High-risk Uveal Melanoma: a Randomized Phase III Study by EORTC
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-03-04
290
Participants Needed
14
Research Sites
N/A
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
Researchers are studying the potential of tebentafusp as an additional treatment following the primary treatment of high-risk uveal melanoma, a type of eye cancer. This trial focuses on patients who have undergone surgery or radiotherapy for non-metastatic uveal melanoma but are at high risk of cancer recurrence. Tebentafusp is the first drug shown to improve survival in patients with metastatic uveal melanoma, and this study explores whether it can reduce the risk of disease recurrence when given after initial treatment. Participants assigned to the treatment group will receive weekly intravenous infusions of tebentafusp, starting with 20 mcg in the first week, then 30 mcg in the second week, followed by 68 mcg in the third week and continuing with this dose weekly for up to 6 months (maximum 26 infusions). Another group will be observed without additional treatment to compare outcomes. The study is randomized and open-label, meaning participants are assigned to groups by chance and both researchers and participants know the assigned treatment. During the study, participants will be closely monitored for recurrence-free survival over approximately 8 years, along with overall survival, occurrence of adverse events, and quality of life. Assessments include imaging to confirm no cancer recurrence before starting, regular health evaluations, and safety monitoring. Participants will be followed for long-term outcomes to understand the effects of tebentafusp as an adjuvant therapy in this setting.
CONDITIONS
Brief 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 surgery or radiotherapy
- Time from primary treatment to randomization less than or equal to 12 weeks
- High-risk disease by TNM stage III or genetic criteria (monosomy 3 or GEP class 2) as declared by site
- ECOG performance status 0 or 1
- Age 18 years or older
- Positive for HLA-A*02:01 by local testing
- No evidence of uveal melanoma recurrence on baseline imaging within 4 weeks prior to randomization
- Adequate organ function
- Evidence of post-menopausal status or negative pregnancy test for women of childbearing potential within 3 days prior to randomization
- Agreement to use effective birth control during study and for 6 months after last dose if of childbearing potential
- Agreement to discontinue breastfeeding prior to first dose and until 6 months after last dose
- Written informed consent according to regulations
You will not qualify if you...
- Significant or uncontrolled heart disease including congestive heart failure NYHA grade ≥ 2, uncontrolled hypertension, or arrhythmia needing treatment
- QTcF > 470 msec on ECG or congenital long QT syndrome
- Heart attack or unstable angina within 6 months before screening
- Active infection requiring systemic antibiotics within 1 week prior to randomization
- Severe or uncontrolled systemic disease or active infection including hepatitis B, hepatitis C, or active HIV (viral load > 200 copies/ml)
- Active autoimmune disease requiring immunosuppressive treatment within 2 years, except certain controlled conditions like vitiligo or psoriasis
- History of another primary cancer within 3 years unless low risk and no ongoing treatment or toxicity
- Psychological, social, or geographical conditions that could interfere with study compliance
- Contraindications to imaging agents or MRI/CT scans due to contrast media allergies or other reasons
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants receive weekly intravenous infusions of tebentafusp for up to 6 months, with escalating doses in the first 3 weeks followed by maintenance dosing.
Weekly visits for up to 26 infusions
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
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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