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).
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 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.