Status:
RECRUITING
IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
Lead Sponsor:
IDEAYA Biosciences
Conditions:
Metastatic Uveal Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 eit...
Detailed Description
This study is designed as a multi-stage Phase 2 study within a Phase 3 study to evaluate the safety, tolerability, pharmacokinetics, dose-exposure relationship, and anti-tumor activity of IDE196 in co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2028
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT05987332
Start Date
October 31 2023
End Date
January 15 2028
Last Update
November 7 2025
Active Locations (68)
Enter a location and click search to find clinical trials sorted by distance.
1
Honor Health
Scottsdale, Arizona, United States, 85258
2
Moores Cancer Center
La Jolla, California, United States, 92093
3
UCLA Medical Center
Los Angeles, California, United States, 90024
4
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025