OptimUM-10: A trial for people with localised ocular melanoma to evaluate whether adding targeted therapy before treatment with either radiation therapy or the removal of the eyeball improves outcomesA Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)

Trial purpose

Cancer treatment

Tumor type

Skin

Age

18+

Trial acronym

OptimUM-10

Summary

This study is divided into 2 cohorts of people with primary uveal (ocular) melanoma requiring either internal radiation therapy (plaque brachytherapy) or the removal of the eyeball (enucleation). Within each cohort, participants will randomly assigned (by chance) to receive one of two treatments.

In Cohort 1, participants will either receive neoadjuvant treatment with darovasertib followed by brachytherapy, or immediate brachytherapy.

In Cohort 2, participants will either receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e. plaque brachytherapy, proton beam radiation, or enucleation), or immediate enucleation.

Participants will then receive primary local therapy following neoadjuvant darovasertib.

All participants will be followed for up to 3 years to assess longer term outcomes such as vision and tumour recurrence. 

Conditions

This trial is treating people with uveal melanoma who require treatment with either plaque brachytherapy or the surgical removal of the eyeball

Not yet recruiting hospitals