Informations générales (source: ClinicalTrials.gov)
IDE196 (Darovasertib) in Combination with Crizotinib Versus Investigator's Choice of Treatment As First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (DAR-UM-2)
Interventional
Phase 2/Phase 3
IDEAYA Biosciences (Voir sur ClinicalTrials)
octobre 2023
janvier 2028
09 octobre 2024
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Sophie Piperno-Neumann, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| The Leon Berard Center - Lyon - France | Eve-Marie Neidhardt, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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