Conditions: Uveal Melanoma
Keywords: Melanoma, melanoma of the eye, uveal, MEK162, AEB071
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: no

Brief summary:
A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed

Detailed description:
Due to halted enrollment, the Phase II part of the study was not conducted. The Sponsor decided to permanently stop recruitment for the study prior to MTD determination.

Remaining patients on treatment with binimetinib and sotrastaurin who were considered by the Investigator to be benefiting from their treatment could have continued treatment and were to be followed up as per protocol. No patients were ongoing as of the data cut-off date. After the last patient last visit (LPLV) was declared, the study was terminated.

Arms:
arm 1: AEB071 and MEK162 combined arm 2: MEK162 alone

Interventions: intervention 1: AEB071 intervention 2: MEK162
Intervention descriptions: intervention 1: Twice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles) intervention 2: Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles)

Protocol document: