Protocolnummer: NL58446.091.16

Cowboy studie (gesloten voor inclusie)

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.

Ziekenhuizen

  • Amphia Ziekenhuis Breda
  • Antoni van Leeuwenhoek (NKI) ziekenhuis Amsterdam
  • Erasmus Medisch Centrum Rotterdam
  • Isala Zwolle
  • Maastricht UMC+
  • Maxima Medisch Centrum Eindhoven
  • RadboudUMC Nijmegen
  • Universitair Medisch Centrum Utrecht

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

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

(on hold)
 

Contactpersoon

R.H.T. Koornstra, RadboudUMC
J.W.B. de Groot , Isala
C. Blank-de Hoop, AvL