Cowboy studie


Protocolnummer:
NL58446.091.16

Ziekenhuizen:
Erasmus Medisch Centrum Rotterdam
Isala Zwolle
Maastricht UMC+
Maxima Medisch Centrum Eindhoven
NKI / A.v.L ziekenhuis Amsterdam
RadboudUMC Nijmegen

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:
Dr. ten Tije en Dr. Westgeest

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