Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma

The goal of this interventional clinical trial is to provide proof-of-principle data for the biologic activity of defactinib in combination with avutometinib in brain metastases from melanoma, and to define the potential role of the combination with mutant BRAF inhibitors or after BRAF/MEK inhibitors in BRAF V600E/K mutant tumors, in individuals with advanced melanoma who experience the development or progression of brain metastases after treatment with immune checkpoint inhibitors. The main questions it aims to answer are: * What is the preliminary response rate of defactinib and avutometin

Trial Details

NCT ID
NCT06194929
Phase
PHASE1 / PHASE2
Sponsor
University of Utah
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Defactinib
  • Avutometinib
  • Encorafenib
Locations (sample)
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Salt Lake City, Utah, United States|40.76078,-111.89105

Key Eligibility Criteria

  • Age ≥ 18 years at the time of informed consent.
  • Provide written informed consent and comply with the study protocol as judged by the Investigator. Of note, If the subject has an impairment that p…
  • Histologically confirmed diagnosis of cutaneous melanoma with radiographically confirmed metastases to the brain.
  • Must have a tumor with a known RAS, BRAF, or NF1 mutation or triple wildtype status using validated testing methods prior to enrollment. Cohorts wi…

For full eligibility, visit ClinicalTrials.gov.

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