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New treatment option for Advanced Unresectable Melanoma
Official title Mirdametinib in Patients With Advanced NF1-mutant Melanoma
ClinicalTrials.gov ID: NCT07237100
What this study is testing
What is Mirdametinib?
Mirdametinib is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for advanced unresectable melanoma.
Also referred to as PD-0325901.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate clinical efficacy of mirdametinib in patients with advanced NF1-mutant melanoma whose disease has progressed while on or after previous immunotherapy. The main questions this study aims to answer are: To evaluate the feasibility of conducting a prospective single-center clinical trial of mirdametinib in patients with advanced NF1-mutant melanoma whose disease progresses during or after PD-1 antibody-based checkpoint inhibitor therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with unresectable or metastatic melanoma with an NF1 mutation; Variance of NF1 of unknown/ uncertain significance will not be eligible; The...
- Patients must have a report of NF1 sequencing analysis performed at CLIA-certified laboratory (by either tissue-based sequencing or liquid biopsy)
- Must have been previously treated with
- anti PD-1/PD-L1 antibody; AND anti CTLA-4 antibody and/or anti LAG3 antibody;
- UNLESS these standard checkpoint inhibitors are not clinically indicated or suitable (for example, comorbid conditions, such as autoimmune disease...
You likely can't join if
- Patients who were previously treated with MEK, ERK or RAF inhibitor therapy
- Patients with symptomatic brain metastasis or active brain lesions ≥ 6 mm size or those who require steroid treatment for brain lesions or...
- No systemic cancer therapy within 28 days of the study drug administration,
- Patients must not be simultaneously enrolled in any therapeutic clinical trial
- Patients must not have had investigational therapy administered ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the...
- Patient has a history of, or evidence of, retinal pathology on ophthalmologic examination that is considered a risk factor for central serous...
See the full eligibility criteria
Who can join
- Patients with unresectable or metastatic melanoma with an NF1 mutation; Variance of NF1 of unknown/ uncertain significance will not be eligible; The genetic analysis for somatic mutations must be performed in a lab that...
- Patients must have a report of NF1 sequencing analysis performed at CLIA-certified laboratory (by either tissue-based sequencing or liquid biopsy)
- Must have been previously treated with
- anti PD-1/PD-L1 antibody; AND anti CTLA-4 antibody and/or anti LAG3 antibody;
- UNLESS these standard checkpoint inhibitors are not clinically indicated or suitable (for example, comorbid conditions, such as autoimmune disease, or significant toxicity with prior checkpoint inhibitor treatment)
- Tumors must be progressing at the time of the enrollment
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Patients must be ≥ 18 years of age
- Patients must have measurable metastatic disease according to RECIST 1.1
- Patients must have adequate organ function, defined as follows:
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 calculated by the...
- Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 x ULN (Grade ≤1) unless liver metastases are present, in which case they must be ≤ 5 x ULN (Grade ≤2).
- Adequate coagulation function, as determined by:
- International Normalized Ratio (INR) ≤ 1.5 × ULN (Grade ≤ 1). If the participant receives anticoagulant therapy, the INR \> 1.5 × ULN is permitted, but the dose must be stable for at least 2 weeks before the start of...
- PTT ≤ 1.5 × ULN.
- Adequate cardiac function, as determined by:
- Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg (Grade ≤ 2).
- LVEF ≥ 50% by MUGA or ECHO.
- No clinically significant ECG waveform abnormalities assessments at screening (one triplicate).
- Have normal serum calcium and phosphate levels (calcium level may be corrected for albumin level).
- Female patients are eligible to enroll and participate in the study if:
- Patient is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
- has had a hysterectomy.
- has had a bilateral oophorectomy (ovariectomy).
- has had bilateral tubal ligation.
- is postmenopausal (total cessation of menses for ≥1 year), OR
- Women of child-bearing potential must agree to use highly effective contraceptive methods (hormonal or barrier method of birth control or abstinence) during the trial period through at least six months after the last...
- Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
What rules you out
- Patients who were previously treated with MEK, ERK or RAF inhibitor therapy
- Patients with symptomatic brain metastasis or active brain lesions ≥ 6 mm size or those who require steroid treatment for brain lesions or leptomeningeal disease
- No systemic cancer therapy within 28 days of the study drug administration,
- Patients must not be simultaneously enrolled in any therapeutic clinical trial
- Patients must not have had investigational therapy administered ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of...
- Patient has a history of, or evidence of, retinal pathology on ophthalmologic examination that is considered a risk factor for central serous retinopathy, retinal vein occlusion (RVO), or neovascular macular...
- Intraocular pressure \> 21 mmHg;
- Serum cholesterol \> 300 mg/dL;
- Serum triglycerides \> 300 mg/dL;
- Hyperglycemia (fasting blood glucose \> 125 mg/dL or random blood glucose \> 200 mg/dL);
- History or current evidence of glaucoma or clinically significant abnormalities on the ophthalmological exam, including but not limited to cataract limiting the ability to examine the retina or any optical coherence...
- History (within 6 months before the start of the study treatments) of clinically significant cardiac disease (New York Heart Association Class III or IV), myocardial infarction, severe/unstable angina...
- Patient who is pregnant or breastfeeding.
- Patient with active bacterial, fungal, or viral infection, including but not limited to the use of antibiotics, antifungals, or antiviral agents at the time of Screening;
- Underlying medical conditions, laboratory abnormality, or alcohol or drug abuse or dependence that, in the Investigator's opinion, will be unfavorable for the administration of study treatment or affect the explanation...
- Patient has experienced other severe acute or chronic medical or psychiatric conditions, including recent (within 1 year of signing informed consent/assent) or active suicidal ideation or behavior, or a laboratory...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.