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Actively Recruiting
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
About
Brief Summary
This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- Histological or cytological confirmed Metastatic Uveal Melanoma
- HLA-A*02:01 negative
- No prior systemic therapy in the metastatic or advanced setting or regional or liver-directed therapy. Ablations or surgical resection of oligometastatic disease, and 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
- High risk of syncope
- Known AIDS related illness or active 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
- History of stroke within the last 6 months of the first dose of study drug
- 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, including institutionalization on the basis of an official or court order
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Study Stats
Protocol No.
23-001238
Category
Head and Neck Cancer
Melanoma (Skin Cancer)
Principal Investigator
Contact
Location
- UCLA Westwood