IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
Metastatic Uveal Melanoma
About this trial
This is an interventional treatment trial for Metastatic Uveal Melanoma focused on measuring IDE196, Darovasertib, Protein Kinase C, Metastatic Uveal Melanoma, Melanoma, Ocular Oncology, Ophthalmology, Crizotinib, Ocular melanoma
Eligibility Criteria
Inclusion Criteria: Histological or cytological confirmed Metastatic Uveal Melanoma HLA-A*02:01 negative No prior systemic therapy in the metastatic or advanced setting, regional or liver-directed therapy, ablations or surgical resection of oligometastatic disease, or neoadjuvant or adjuvant therapy is allowed Measurable disease per RECIST 1.1 Able to be safely administered and absorb study therapy ECOG performance status 0 or 1 Life expectancy of ≥3 months Adequate organ function Exclusion Criteria: Previous treatment with a PKC inhibitor (including prior treatment with IDE196), an inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11 Concurrent malignant disease AEs from prior anti-cancer therapy that have not resolved to Grade ≤1 Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids Active HIV infection or Hep B/C Active adrenal insufficiency, active colitis, or active inflammatory bowel disease History of interstitial lung disease, active pneumonitis, or history of pneumonitis Active infection requiring systemic antibiotic therapy Use of hematopoietic colony-stimulating factors (CSF) prior to start of study drug Females who are pregnant or breastfeeding History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies Contraindication for treatment with investigator's choice therapies as per applicable labelling Has any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the participant inappropriate for entry into the study
Sites / Locations
- Moores Cancer Center
- UCLA Medical Center
- The Angeles Clinic and Research Institute
- California Pacific Medical Center (CPMC)
- University of California San Francisco
- SCRI at HealthONERecruiting
- University of Miami Sylvester Comprehensive Cancer Center
- Moffitt Cancer Center
- Northside Hospital Atlanta
- University of Iowa
- Massachusetts General Hospital
- Dana Farber Cancer InstituteRecruiting
- The Cancer and Hematology CentersRecruiting
- Roswell Park Cancer Institute
- Northwell Health
- Duke University Health System
- University of Cincinnati
- The Cleveland Clinic Foundation
- Thomas Jefferson UniversityRecruiting
- University of Pittsburgh Medical Center
- SCRI at Tennessee OncologyRecruiting
- UT Southwestern Medical Center
- Houston Methodist Cancer Center
- MD Anderson Cancer Center
- Westmead Hospital
- Princess Alexander Hospital
- Alfred Health
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Phase 2a Dose Optimization of IDE196 + crizotinib
Phase 2b / 3 Chosen Combination dose of IDE196 + crizotinib
Phase 2a / 2b / 3 Comparator Arm
Multiple doses of IDE196 will be tested in combination with fixed dose of crizotinib to identify the optimal combination dose.
Chosen combination dose of IDE196 + crizotinib will be tested in additional participants.
Participants will receive investigator's choice of Pembrolizumab, Ipilimumab + Nivolumab, or Dacarbazine.