Study on Mirdametinib for Patients with Advanced NF1-Mutant Melanoma
Sponsor: Kevin Kim, MD
ClinicalTrials ID:NCT07237100
This clinical trial is testing the effectiveness and safety of mirdametinib, a targeted therapy, in patients with advanced melanoma that has a specific NF1 mutation and has progressed after previous immunotherapy.
Patient Parameters
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Program Overview
The purpose of this study is to see if mirdametinib can help slow down or stop the growth of melanoma with an NF1 mutation that has advanced and not responded to previous treatments. Mirdametinib is a type of targeted therapy known as a MEK inhibitor, which works by blocking certain pathways in cancer cells that make them grow and divide quickly. This study aims to find out if mirdametinib is safe and effective for patients with this type of melanoma.
Description
This study is designed to test if mirdametinib is safe and effective in improving the condition of patients with advanced NF1-mutant melanoma. Mirdametinib is a targeted therapy that focuses on specific pathways in cancer cells, potentially slowing or stopping their growth. Unlike traditional chemotherapy, it targets cancer cells more directly, which may result in fewer side effects.
The study will evaluate if mirdametinib can help control the disease in patients whose melanoma has progressed after previous treatments, such as PD-1 antibody-based therapies. Researchers will also assess the safety profile of mirdametinib in these patients.
Eligibility Criteria
Inclusion Criteria
- Have melanoma that cannot be removed by surgery or has spread, with an NF1 mutation confirmed by a certified lab.
- Have previously been treated with certain immunotherapy drugs unless not suitable due to other health conditions.
- Cancer must be progressing at the time of joining the study.
- Be 18 years or older.
- Have measurable cancer according to specific criteria.
- Have adequate organ function, including specific blood cell counts and liver and kidney function.
- Have normal heart function and blood pressure.
- Women must not be pregnant and must agree to use effective birth control during and after the study.
- Be able to understand and agree to participate in the study by signing a consent form.
Exclusion Criteria
- Have been treated with MEK, ERK, or RAF inhibitors before.
- Have active or untreated brain cancer or need steroids for brain conditions.
- Have had cancer treatment within 28 days before starting the study drug.
- Be enrolled in another clinical trial.
- Have certain eye conditions that increase the risk of eye problems.
- Have had significant heart problems or other serious health issues recently.
- Be pregnant or breastfeeding.
- Have active infections or other medical conditions that could interfere with the study.
- Have a history of severe mental health issues or substance abuse that could affect participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| California Pacific Medical Center - Sutter Health | 94115 | San Francisco | California |
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