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

{ "Nilotinib with Dabrafenib/Trametinib or Encorafenib/Binimetinib for Metastatic Melanoma", "This study is testing different doses of nilotinib when given with standard melanoma treatments (dabrafenib and trametinib, or encorafenib and binimetinib). It's for people with metastatic melanoma (cancer that has spread) that has a specific change in the BRAF gene (BRAF V600 mutation). The main goal is to find out if these combinations are safe and to determine the highest dose of nilotinib that can be given without causing too many side effects. Researchers also want to see how the drugs interact in your body. About 30 people are expected to join this study. This study is currently recruiting participants.", "design": "This is a Phase 1 study, meaning it's an early-stage trial to test safety and dosage. It will involve about 30 participants.", "commitments": "You would start taking dabrafenib and trametinib, or encorafenib and binimetinib for 28 days. After 7 days, nilotinib would be added and continued for 21 days. You would have radiological evaluations and tissue biopsies.", "compensation": "Not stated in the trial record.", "follow_up": "The primary endpoint for safety is measured at 28 days. The study also involves regular study visits for the duration of the trial to collect pharmacokinetic samples.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04903119

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Rina Plattner
~30 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Nilotinib 100mgNilotinib 200mgNilotinib 300mgNilotinib 400mgDabrafenibTrametinib

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Patients Experiencing Dose Limiting Toxicities
Measured over 28 days
Metastatic Melanoma
BRAF Gene Mutation
4 sites across 4 states
Iowa1
Kentucky1
Pennsylvania1
Tennessee1
  • Ruta Arays, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky
  • Rina Plattner, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky

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  • Percentage of Patients Experiencing Dose Limiting Toxicities28 days

    Percentage of patients who experienced dose-limiting toxicities associated with Nilotinib as defined by the study protocol.