RecruitingPhase 1Phase 2NCT06194929

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

Phase 1b/2 Trial of Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma


Sponsor

University of Utah

Enrollment

33 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — defactinib (a FAK inhibitor) and avutometinib (a MEK inhibitor), with or without encorafenib (a BRAF inhibitor) — for people with melanoma skin cancer that has spread to the brain. **You may be eligible if...** - You are 18 or older with confirmed cutaneous (skin) melanoma that has spread to the brain - You have at least one untreated brain metastasis between 0.5 cm and 4 cm in size - Your tumor has a known mutation status (BRAF, RAS, NF1, or wildtype) - You have received at least one prior immunotherapy treatment - Your general health and organ function meet study requirements **You may NOT be eligible if...** - All of your brain metastases have already been treated with surgery or radiation - You have active autoimmune disease requiring systemic treatment - You have significant cardiovascular disease (e.g., recent heart attack) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDefactinib

Defactinib will be administered at 200 mg twice daily orally per arm description.

DRUGAvutometinib

Avutometinib will be administered at 3.2 mg twice a week orally per arm description.

DRUGEncorafenib

Encorafinib administered orally per arm description.


Locations(2)

University of Iowa

Iowa City, Iowa, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

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NCT06194929


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