Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma (NCT04903119)
A Phase 1 Study of Nilotinib in Combination With Dabrafenib and Trametinib or Encorafenib/Binimetinib in BRAF V600 Mutant Metastatic Melanoma After Progression on BRAF/MEK Inhibition
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Iowa โ Iowa City, Iowa
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (4 Sites)
- University of Iowa โ Iowa City, Iowa
- Markey Cancer Center โ Lexington, Kentucky
- St. Luke's University Health Network โ Easton, Pennsylvania
- Vanderbilt-Ingram Cancer Center โ Nashville, Tennessee
๐ Contact the Study Coordinator
Phone: (859) 323-7628
Email: heather.schroer@uky.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Melanoma
- Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma โ Boston, Massachusetts
- IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) โ Orange City, Florida
- Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies โ Jacksonville, Florida
- Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma โ Houston, Texas
- Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients โ Louisville, Kentucky
- Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. โ Portland, Oregon
Explore by condition: All Metastatic Melanoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.