OncoMatch/Clinical Trials/NCT04903119
Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
Is NCT04903119 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for metastatic melanoma.
Treatment: Nilotinib 100mg · Nilotinib 200mg · Nilotinib 300mg · Nilotinib 400mg · Dabrafenib · Trametinib · Encorafenib · Binimetinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: BRAF V600
Patients must have a BRAF V600 mutation. Any CLIA-certified mutation testing is acceptable to document mutation status.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: BRAF inhibitor and/or MEK inhibitor (dabrafenib, trametinib, encorafenib, binimetinib) — must have stable disease on BRAFi/MEKi for >= 3 months OR have failed any BRAFi/MEKi regimen
Patients must have stable disease on dabrafenib and trametinib or on encorafenib and binimetinib for a duration of greater than or equal to 3 months OR have failed any BRAFi/MEKi regimen to qualify for the trial, including the dabrafenib/trametinib combination and/or the encorafenib/ binimetinib combination.
Cannot have received: other prior therapies (except immunotherapy, cellular therapy, or radiation)
Exception: immunotherapy, cellular therapy, and radiation are allowed
Other prior therapies are not allowed, with the exception of radiation. Patient may have had prior immunotherapy for metastatic disease or prior cellular therapy (although NOT mandatory).
Lab requirements
Blood counts
absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL
Kidney function
creatinine ≤ institutional ULN OR GFR ≥60 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2
Liver function
total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
Cardiac function
NYHA Functional Classification class 2B or better; baseline QTc (Fridericia) ≤470 msec in males and ≤480 msec in females
Patients must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2. Patients with long QT syndrome or baseline QTc (Fridericia) >470 msec in males and >480 msec in females (ULN for each respectively) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Iowa · Iowa City, Iowa
- Markey Cancer Center · Lexington, Kentucky
- St. Luke's University Health Network · Easton, Pennsylvania
- Vanderbilt-Ingram Cancer Center · Nashville, Tennessee
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