Adjuvant Tebentafusp in High Risk Ocular Melanoma

Recruiting Phase 3 Interventional Study
Uveal Melanoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
290 (estimated)
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC · Research network
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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 hypothe…
Trial Locations
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Eligibility Criteria
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 eith…
Contacts

EORTC HQ

+32 2 774 16 11

eortc@eortc.org

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