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drugset / Trial / NCT04903119

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

NCT04903119 ↗

Phase 1 Recruiting 30 enrolled Rina Plattner National Cancer Institute (NCI) · collabNovartis · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2022-06-01
Primary completion
2028-07-01
Completion
2030-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabrafenib Small molecule 150 mg Oral
Subject Nilotinib Small molecule 100 mg Oral
Subject Nilotinib Small molecule 200 mg Oral
Subject Nilotinib Small molecule 300 mg Oral
Subject Nilotinib Small molecule 400 mg Oral
Background Binimetinib Small molecule 45 mg Oral
Background Encorafenib Small molecule 450 mg Oral
Background Trametinib Small molecule 2 mg Oral

Indications

metastatic melanoma