Open
Actively Recruiting
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
About
Brief Summary
This is a randomized, multi-center, open-label study of adjuvant darovasertib in participants with non-metastatic uveal melanoma (OptimUM-11)
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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 following exceptions: malignancies that were treated curatively and have not recurred within 2 years prior to randomization, completely resected basal cell and squamous cell skin cancers, any malignancy considered to be indolent and never required systemic therapy, and any type of carcinoma in situ receiving curative therapy (resection)
- Known AIDS related illness
- History of interstitial lung disease, active pneumonitis, or history of noninfectious pneumonitis requiring steroids
- History of syncope may be exclusionary, but will be reviewed on a case-by-case basis
- Active Hepatitis B or C infection
- Any gastrointestinal condition (eg, inflammatory bowel disease, major gastric or intestinal surgery) that could affect absorption or ability to swallow
- Females who are pregnant or breastfeeding
- Impaired cardiac function
- History of stroke within the last 6 months of randomization
- Ongoing use of medication use for infections, other antineoplastic therapies, or other prohibited medications, including medications that interact with the metabolism of darovasertib+crizotinib
- allergy to mammalian meat products or gelatin
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
26-1381
Category
Head and Neck Cancer
Melanoma (Skin Cancer)
Principal Investigator
Bartosz Chmielowski, MD, PhD
Sarcoma and Connective Tissue Medical Oncology, Cutaneous (Skin) Medical Oncology
Contact
- Fady Bertan