| Title |
IDE196 (Darovasertib) in Combination With Crizotinib Versus Investigator's Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma |
| Protocole ID |
IDE196-002 |
| ClinicalTrials.gov ID |
NCT05987332 |
| Cancer Type(s) |
Melanoma |
| Phase |
Phase II-III |
| Stage |
Metastatic |
| Study Type |
Clinical |
| Drug |
Darovasertib avec crizotinib versus une thérapie au choix de l'investigateur |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Rahima Jamal
|
| Coordinator |
Chantal Gosselin
514-890-8000 poste 24892
|
| Status |
Recruiting |
| Activation Date |
29-04-2024 |
| Eligibility 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
|
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Groupe d'étude en oncologie du Québec