IDEAYA Biosciences
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…
Inclusion Criteria: * Primary Uveal Melanoma, classified as high-risk of relapse (AJCC Stage II or Stage 3) * Completed primary local therapy (enucleation, proton beam therapy, plaque brachytherapy) * ECOG performance status of 0 or 1 * Adequate organ function * Age 18 or older * Written informed consent and ability to comply * Primary local therapy completed within 120 days before C1D1/randomization. * Contraception requirements Exclusion Criteria: * Previous systemic treatment for Uveal Melanoma * Clinical or radiological evidence of metastatic UM * Concurrent malignant disease with the f…
Oral, selectively targets key proteins
Oral small molecule