Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or … (NCT07743554) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or Unresectable Malignant Peripheral Nerve Sheath Tumor
23 participantsStarted 2027-01-01
Plain-language summary
The purpose of this study is to learn whether the study drugs avutometinib and defactinib can help stop or shrink malignant peripheral nerve sheath tumors (MPNST) that have returned or cannot be removed with surgery.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 12 years old with a body surface area (BSA) of at least 1.5 mm2
* DIAGNOSIS: Participants with relapsed, refractory, unresectable or metastatic histologically confirmed NF1 associated or sporadic MPNST.
* Participants must have available archival tissue. Tissue blocks strongly preferred. Exceptions may be made following discussion with study team if tissue has been exhausted.
* MEASURABLE DISEASE: Participants must have measurable disease by RECIST v1.1.
* THERAPEUTIC OPTIONS: Participants must have experienced relapse/progression or demonstrated disease that is refractory to one or more prior regimens of cytotoxic chemotherapy or participants who must have declined cytotoxic chemotherapy.
* PRIOR THERAPY
* Participants may not have previous exposure to combination treatment with a MEK/FAK inhibitor in combination. Participants may have received MEK inhibitor or FAK inhibitor as a single agent for prior therapy.
* Participants must have not had a serious adverse event (CTCAE grade III or IV) to prior MEK inhibitor or FAK inhibitor drugs.
* Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study. If the participant is experiencing unresolved toxicity from previous treatment they may still be enrolled in the study as long as it is not expected to be worsened by active treatment or deemed unsafe by the study team.
* No limitation on the number of…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of participants that were progression free at four months treated with defactinib and avutometinib.