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

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

Trial Details

NCT ID
NCT04903119
Phase
PHASE1
Sponsor
Rina Plattner
Status
RECRUITING
Cancer Type
BRAF Mutated Melanoma
Interventions
  • Nilotinib 100mg
  • Nilotinib 200mg
  • Nilotinib 300mg
  • Nilotinib 400mg
  • Dabrafenib
  • Trametinib
Locations (sample)
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Lexington, Kentucky, United States|37.98869,-84.47772
  • Easton, Pennsylvania, United States|40.68843,-75.22073
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

  • 1.1 Patients must have histologically confirmed metastatic or unresectable melanoma.
  • Radiological evaluation should occur within 28 days prior to enrollment initiation.
  • 1.2 Patients must have a BRAF V600 mutation. Any CLIA-certified mutation testing is acceptable to document mutation status.
  • 1.3 Patients must have stable disease on dabrafenib and trametinib or on encorafenib and binimetinib for a duration of greater than or equal to 3 m…

For full eligibility, visit ClinicalTrials.gov.

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