Combi i studie


Protocolnummer:
CPDR001F2301

Ziekenhuizen:
Leids Universitair Medisch Centrum
Medisch Spectrum Twente Enschede
Universitair Medisch Centrum Groningen

Titel:
A randomized double blind placebo controlled phase III study comparing the combination of PDR001,dabrafennib and trametinib versus placebo, dabrafenib and trametinib in previously untreated opateitns with unresectable or metastatic BRAF V600 mutant melanoma.

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 status 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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