Phase 2 study testing the combination of vemurafenb with cobimetinib in BRAF V600E/K mutated melanoma patients to normalize LDH and optimizze immunotherapy with nivolumab and Ipilimumab.
To compare efficacy of induction vemurafenib and cobimetinib followed by ipilimumab and nivolumab treatment (arm A) versus upfront ipilimumab and nivolumab treatment Arm B.
stadium: Stage IV or unresectable stage III, BRAF V600 E/K mutated melanoma
induction vemurafenib and cobimetinib followed by ipilimumab and nivolumab treatment (arm A) versus upfront ipilimumab and nivolumab treatment Arm B
- WHO 0-2
- Stage IV or unresectble stage III
- Measurable disease according to RECIST 1.1
- No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1
- LDH>ULN<3xULN
(on hold)
R.H.T. Koornstra, RadboudUMC
J.W.B. de Groot , Isala
C. Blank-de Hoop, AvL