Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma (NCT06194929)
Phase 1b/2 Trial of Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Iowa — Iowa City, Iowa
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- University of Iowa — Iowa City, Iowa
- Huntsman Cancer Institute — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (801) 585-0115
Email: rachel.kingsford@hci.utah.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Cutaneous Melanoma
- Neoadjuvant Atezolizumab in Cutaneous Melanoma — Houston, Texas
- Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma — Boston, Massachusetts
- Exercise to Boost Response to Checkpoint Blockade Immunotherapy — Orlando, Florida
- Exercise to Boost Response to Checkpoint Blockade Immunotherapy — Tampa, Florida
- A Randomized Phase III Study of Management of Treatment Naive Primary Melanoma in Elderly Patients — Pittsburgh, Pennsylvania
- Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma — San Francisco, California
Explore by condition: All Cutaneous Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.