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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
290
Tebentafusp will be administered weekly i.v.
Cliniques Universitaires Saint-Luc
Brussels, Belgium
RECRUITINGCentre Antoine Lacassagne
Nice, France
RECRUITINGInstitut Curie - Hôpital de Paris
Paris, France
RECRUITINGCharite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany
RECRUITINGUniversitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Hamburg, Germany
RECRUITINGUniversitaetsklinikum Heidelberg - Frauenklinik / Hautklinik
Heidelberg, Germany
RECRUITINGLeiden University Medical Centre
Leiden, Netherlands
RECRUITINGMaria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
RECRUITINGInstitut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)
L'Hospitalet de Llobregat, Spain
RECRUITINGHospital Clinico Universitario De Valladolid
Valladolid, Spain
RECRUITING...and 3 more locations
Recurrence-Free survival (RFS)
RFS is defined as the time between randomization and local recurrence, distant recurrence, or death, whichever occurs first
Time frame: 8.1 years from first patient in
Overall Survival (OS)
OS is defined as the time between randomization and death
Time frame: 8.1 years from first patient in
Occurrence of Adverse Events
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting
Time frame: 8.1 years from first patient in
Health-related Quality of Life
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
Time frame: 8.1 years from first patient in
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