This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
This study will enroll participants who are at high-risk for metastatic disease and who have completed primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation) for their UM without evidence of active local or metastatic disease after this treatment. The Treatment Arm will have participants who have completed PLT and will receive darovasertib + crizotinib. The Observation Arm participants will not receive darovasertib + crizotinib but will be observed and followed for disease recurrence and survival (Control Arm) Participants in both arms will be followed for up to five years to assess longer term outcomes such as tumor recurrence and survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Oral, selectively targets key proteins
Oral small molecule
Honor Health Research Institute
Scottsdale, Arizona, United States
RECRUITINGUCLA Medical Center
Los Angeles, California, United States
Median relapse-free survival
Time to local recurrence or metastatic disease per Blinded Independent Central Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: Approximately 5 years
Median metastasis-free survival
Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) by BICR per RECIST v 1.1
Time frame: Approximately 5 years
Overall survival
Overall survival with darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease who are at high-risk for recurrence
Time frame: Approximately 5 years
Median UM specific survival
Median UM specific survival defined as the time from randomization to the date of death due to UM
Time frame: Approximately 5 years
Median metastasis-free survival
Median MFS, defined as the time from randomization to the date of metastatic disease (outside of the eye or orbit) as assessed by investigator
Time frame: Approximately 5 years
Safety, and severity of occurrence of adverse events (AEs) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V6.0 or later
To assess safety and tolerability of darovasertib + crizotinib in participants who have completed PLT for primary UM
Time frame: Approximately 3 years
Change from baseline over time and across Treatment Arms as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ-C30)
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
NOT_YET_RECRUITINGCancer Hematology Centers Western Michigan
Grand Rapids, Michigan, United States
NOT_YET_RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
NOT_YET_RECRUITINGNorthwell Health
New York, New York, United States
NOT_YET_RECRUITINGDuke Cancer Center
Raleigh, North Carolina, United States
NOT_YET_RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
NOT_YET_RECRUITINGWills Eye Hospital at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGSarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States
RECRUITING...and 3 more locations
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
Time frame: Approximately 5 years
Recurrence-free suvival
Compare RFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Time frame: Approximately 5 years
Metastasis-Free Survival
Compare MFS of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Time frame: Approximately 5 years
Median Local Recurrence-Free Survival
Compare local RFS (LRFS) of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM with no evidence of metastatic disease and who are at high-risk for recurrence
Time frame: Approximately 5 years
Change from baseline over time and across Treatment Arms as measured by European Quality of Life Questionnaire EQ-5D-5L.
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
Time frame: [Time Frame: Approximately 5 years]
Change from baseline over time and across Treatment Arms as measured by EORTC Oncology Quality of Life Questionnaire Ophthalmic-30 (EORTC QLQ-OPT30)
Compare quality of life outcomes of darovasertib + crizotinib versus observation in participants who have completed PLT for primary UM
Time frame: [Time Frame: Approximately 5 years]