Nilotinib Plus Dabrafenib/Trametinib in Metastatic Melanoma
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This is a phase 1 dose-escalation study of nilotinib in combination with fixed-dose
dabrafenib and trametinib regimen for patients with metastatic or unresectable melanoma
carrying a BRAF V600 mutation and have relapsed on a BRAF/MEK inhibitor therapy. The goal is
to assess the toxicity and tolerability and determine the maximum tolerated dose
(MTD)/recommended phase 2 dose (RP2D) of the combination of nilotinib with dabrafenib and
trametinib. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and
nilotinib when used in combination.