Cowboy studie
Protocolnummer:
NL58446.091.16
Ziekenhuizen:
Amphia Ziekenhuis Breda
Erasmus Medisch Centrum Rotterdam
Isala Zwolle
Maastricht UMC+
Maxima Medisch Centrum Eindhoven
NKI / A.v.L ziekenhuis Amsterdam
RadboudUMC Nijmegen
Universitair Medisch Centrum Utrecht
Titel:
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.
Doel van het onderzoek:
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
Behandeling:
induction vemurafenib and cobimetinib followed by ipilimumab and nivolumab treatment (arm A) versus upfront ipilimumab and nivolumab treatment Arm B
Stadium:
Stadium irresectable IIIc/IV
Belangrijkste in/exclusiecriteria:
- 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
Contactpersoon:
R.H.T. Koornstra, RadboudUMC
J.W.B. de Groot , Isala
C. Blank-de Hoop, AvL