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 melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator’s choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).
Intervention / Treatment
- Drug: IDE196
- Drug: Crizotinib
- Drug: Pembrolizumab
- Drug: Ipilimumab
- Drug: Nivolumab
- Drug: Dacarbazine
Inclusion Criteria:
- Histological or cytological confirmed Metastatic Uveal Melanoma
- HLA-A*02:01 negative
- No prior systemic therapy in the metastatic or advancedat a late stage, far along setting or regional or liver-directed therapy. Ablations or surgical resectionsurgical removal of tissue or part/all of an organ 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.