IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma
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).
Timeline
- Start
- 2023-10-31
- Primary completion
- 2027-01-15
- Completion
- 2028-01-15
Outcome
Met primary endpoint
release “Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint” ideayabio.com ↗
release “Key Findings from OptimUM-02 Primary endpoint (Phase 2 portion): progression free survival by BICR The trial met the primary endpoint” ideayabio.com ↗
release “OptimUM-02 trial of darovasertib in combination with crizotinib in 1L HLA*A2-negative mUM. The trial met its primary endpoint” ideayabio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crizotinib | Small molecule | — | Oral |
| Comparator | Dacarbazine | Small molecule | — | Intravenous |
| Subject | Darovasertib | Small molecule | — | Oral |
| Comparator | Ipilimumab | Monoclonal antibody | — | Intravenous |
| Comparator | Nivolumab | Monoclonal antibody | — | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | — | Intravenous |