A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)
Summary
This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)
Detailed description
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.
Arms & interventions
- DrugDarovasertib
Dosed orally, twice daily (28-day/ cycle
- ProcedurePrimary Local Therapy
Plaque Brachytherapy or Enucleation
Outcome measures
Primary
Cohort 1: To demonstrate that the proportion of subjects with vision loss is lower for subjects in the Treatment Arm vs the Control Arm
Loss of Best Corrected Visual Acuity (BCVA) of ≥ 15 letters using Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA
Time frame: Approximately 3 years
Cohort 2: To demonstrate the ability to salvage the eye and prevent enucleation in the Treatment Arm
Eye preservation rate
Time frame: Approximately 2 years
Eligibility criteria
Study locations (35)
Mayo Clinic Scottsdale - PPDS
Scottsdale, Arizona, 85259
UCSD Moores Cancer Center
La Jolla, California, 92093
Jules Stein Eye Institute
Los Angeles, California, 90024
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of California Irvine Medical Center
Orange, California, 92868
Stanford Comprehensive Cancer Center
Palo Alto, California, 94304
Kaiser Permanente-Riverside Medical Center
Riverside, California, 92505-3043
UCSF Wayne and Gladys Valley Center for Vision
San Francisco, California, 94143
University of Colorado Hospital
Aurora, Colorado, 80045
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113-2791
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
USF Health Eye Institute
Tampa, Florida, 33612-6601
Moffit Cancer Center
Tampa, Florida, 33612
Wilmer Eye Institute
Baltimore, Maryland, 21287-0005
Massachusetts General Hospital
Boston, Massachusetts, 02114
W Kellogg Eye Center
Ann Arbor, Michigan, 48105
The Cancer and Hematology Centers of West Michigan (CHCWM)
Grand Rapids, Michigan, 49503
Mayo Clinic - PPDS
Rochester, Minnesota, 55905
TIERING Percentiles
Omaha, Nebraska, 68105
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center - 1275 York Ave
New York, New York, 10065-6635
Northwell Health Cancer Institute
New York, New York, 11042
Cole Eye Institute-9500 Euclid Ave
Cleveland, Ohio, 44195
Ohio State Eye and Ear Institute
Columbus, Ohio, 43212
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, 73112
Jefferson Health Honickman Center
Philadelphia, Pennsylvania, 19107
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
SCRI Oncology Partners
Nashville, Tennessee, 37203
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
Austin Retina Associates - Central
Austin, Texas, 78705
Texas Retina Associates - Dallas
Dallas, Texas, 75231
University of Texas Southwestern Medical Center-5323 Harry Hines Blvd
Dallas, Texas, 75390-9057
Retina Consultants of Texas - (Houston)
Houston, Texas, 77030-2727
Augusta Health, Center for Cancer and Blood Disorders
Fishersville, Virginia, 22939
University of Wisconsin Health
Madison, Wisconsin, 53705-3644