Adjuvant Tebentafusp in High Risk Ocular Melanoma
ConditionUveal Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
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.
Eligibility criteria
Qualifiers
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 declared by the site.
ECOG performance status of 0 or 1
Disqualifiers
Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment
QTcF > 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs obtained over a brief time interval (i.e., within 30 minutes)
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 have completed therapy at least 1 week prior to randomization
Trial design
Treatments tested in this trial
- Tebentafusp
Treatment groups
290 Participants
are divided into 2 treatment groupsSponsors and collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Lead sponsor
Northwell Health
Collaborator
Immunocore Ltd
Collaborator
Source ClinicalTrials.gov