Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRina Plattner

About this trial

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 or with encorafenib and binimetinib. Additionally, this study will assess pharmacokinetic parameters of dabrafenib and nilotinib when used in combination.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Nilotinib 100mg
  • Nilotinib 200mg
  • Nilotinib 300mg
  • Nilotinib 400mg
  • Dabrafenib
  • Trametinib
  • Encorafenib
  • Binimetinib

Treatment groups

30 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Rina Plattner

Lead sponsor

University of Kentucky

Sponsor institution

Novartis

Collaborator

National Cancer Institute (NCI)

Collaborator