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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: Recruiting Phase 1 study of Brain Metastases and Cutaneous Melanoma, sponsored by University of Utah.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For Cohort A, the primary objective will be to evaluate preliminary response rate of defactinib and avutometinib in patients with RAS mutant, BRAF mutant, NF1 mutant, and triple RAS/BRAF/NF1 wild type (wt) melanoma (includes RAF fusions). Measurable target lesions to be defined as all untreated and measurable (≥ 0.5 cm by 2 dimensional diameter measurements) present at the time of enrollment on study.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2024-03-20 |
| Est. Completion | 2030-01-15 |
| Phase | Phase 1 |
What NCT06194929 shows while recruiting
NCT06194929 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06194929's enrollment target sits among peer trials
33 41st of 67 higher than 27 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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