Universitair Medisch Centrum Utrecht
A phase lb/ll, multicenter, study of LEE011 in combination with LGX818 in adult patients with BRAF mutant melanomas.
Phase 1b, phase ll arm 1 a and phase ll arm 2 -LGX818 + LEE011; phase ll arm 1b LGX818 only
Stadium irresectable IIIc/IV
In: ECOG status 0-2, patients for phase 1b must have measurable disease as by RESIST v1.1., patients for phase ll (BRAFi naive and resistant) must have measurable disease as by RESIST v1.1. Ex: Symptomatic brain metastases, inadequate laboratory values, in the phase ll BRAFi naive arms (1a/b) , prior exposure to CDK4/6 inhibitor, impaired GI function, known diagnosis of HIV of Hepatitis C.