European Organisation for Research and Treatment of Cancer - EORTC
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.
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 declare…
Tebentafusp will be administered weekly i.v.