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NCT06194929 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Brain Metastases and Cutaneous Melanoma, sponsored by University of Utah.

Recruiting
Registry status
Phase 1
Development phase
33
Enrollment target
2
Study locations

NCT06194929 is a Phase 1 study of Brain Metastases and Cutaneous Melanoma that is actively recruiting participants, run by University of Utah. The registered enrollment target is 33 participants, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT06194929, a Phase 1 study of Brain Metastases and Cutaneous Melanoma, is actively recruiting participants, sponsored by University of Utah.

RECRUITING
Registry status
Phase 1
Development phase
33 participants
Enrollment target
2
Study locations

Study Summary

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 avutometinib in patients with RAS mutant, BRAF mutant, NF1 mutant, triple RAS/BRAF/NF1 wild type (wt) melanoma (including RAF fusions)? * What is the safety and tolerability of the combination of defactinib, avutometinib, and encorafenib in patients with BRAF V600E/K mutant melanoma with at least one untreated brain metastases? * What is the preliminary response rate of the three drug combination of defactinib, avutometinib, and encorafenib in patients with BRAF V600E/K mutant melanoma.

Conditions Studied

Brain Metastases Cutaneous Melanoma

Interventions

  • DRUG Avutometinib
  • DRUG Defactinib
  • DRUG Encorafenib

Study Locations (2)

Iowa

  • University of Iowa - Iowa City

Utah

  • Huntsman Cancer Institute - Salt Lake City

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2024-03-20
Est. Completion 2030-01-15
Phase Phase 1

Sponsor

University of Utah

818 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06194929

The ClinicalTrials.gov registry entry for NCT06194929 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (84% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Brain Metastases appearing as the primary indexed condition, and to 3 interventions - of which Avutometinib is the first listed.

NCT06194929 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Iowa, Utah.

Frequently Asked Questions

What is clinical trial NCT06194929 about?

NCT06194929 is a clinical study titled "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 inhibitor...

What is the current status of trial NCT06194929?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2024-03-20. Estimated completion is 2030-01-15.

What conditions does trial NCT06194929 study?

This clinical trial studies the following conditions: Brain Metastases, Cutaneous Melanoma.

What interventions are being tested in trial NCT06194929?

The interventions under investigation include: Avutometinib (DRUG), Defactinib (DRUG), Encorafenib (DRUG).

Who is sponsoring clinical trial NCT06194929?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06194929 being conducted?

This trial has 2 study locations across Iowa, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.