A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation.
In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm).
In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation.
Subjects will then receive primary local therapy following neoadjuvant darovasertib.
All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.
Inclusion Criteria:
Exclusion Criteria:
IDEAYAClinicalTrials@ideayabio.com+1-855-433-2246
mchao@ideayabio.com
Scottsdale, Arizona 85259, United States
Los Angeles, California 90033, United States
Orange, California 92868, United States
San Francisco, California 94143, United States
Englewood, Colorado 80113-2791, United States
Grand Rapids, Michigan 49503, United States
New York, New York 10065-6635, United States
Dallas, Texas 75390-9057, United States
Fishersville, Virginia 22939, United States
Westmead, NSW 2145, Australia
Prague, Prague 169 02, Czechia
Copenhagen O, Capital 2100, Denmark
Thessaloniki, Thessaloníki 546 36, Greece
Ramat Gan, Central District 5262100, Israel
Naples, Campania 80131, Italy
Perugia, Perugia, Italy
Pisa, 56124, Italy
Poznan, Greater Poland Voivodeship 61-848, Poland
Warsaw, Masovian Voivodeship 04-141, Poland
Gdansk, Pomeranian Voivodeship 80-214, Poland
Banská Bystrica, 975 17, Slovakia
L'Hospitalet de Llobregat, Barcelona 8907, Spain
Valencia, Valencia 46026, Spain
Metropolitan Borough of Wirral, Merseyside CH63 4JY, United Kingdom