Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05170334 | Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma | PHASE2 | ACTIVE NOT_RECRUITING | 7 | — | — | Dec 15, 2021 | Jan 1, 2028 | Apr 6, 2026 | 1 | United States |
Overall Response Rate (ORR) defined as proportion of patients to have achieved a complete or partial response per RECIST v1.1 criteria.
| Arm | Type | Description |
|---|---|---|
| Binimetinib + Belinostat | EXPERIMENTAL | Participants will receive binimetinib by mouth two times a day, every day during each cycle. Each cycle will last for 21 days. Participants will receive belinostat by intravenous infusion on days 1 through 5 of each cycle. |
| Name | Type | Description |
|---|---|---|
| Binimetinib | DRUG | Binimetinib will be given at 45 mg orally twice daily during each cycle of 21 days, for up to 16 cycles. |
| Belinostat | DRUG | Belinostat will be administered IV at 1,000 mg/m2 daily on days 1 to 5 every 21 days during each 21 day cycle, for up to 16 cycles |
Inclusion Criteria: * Provision of signed and dated informed consent form. * Male or female, aged \>/= 18 years old * Life expectancy of greater than 3 months in the opinion of the investigator * Must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically d...