RECRUITINGPhase 4INTERVENTIONAL

RWS of Tunlametinib in NRAS-Mutant Advanced Melanoma

A Prospective, Open-Label, Multicenter, Real-World Study to Evaluate the Efficacy and Safety of Tunlametinib in Patients With NRAS-Mutant Advanced Melanoma

About This Trial

This study is a prospective, open-label, multicenter, real-world clinical study to evaluate the efficacy and safety of tunlametinib in patients with NRAS-mutant advanced melanoma who have failed prior anti-PD-1/PD-L1 therapy.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged ≥18 years (inclusive), male or female; - Patients with diagnosed by tissue sample (biopsy-confirmed) locally advanced or metastatic melanoma; - Prior genetic testing results showing positive NRAS mutation; - Patients who have failed prior anti-PD-1/PD-L1 therapy; - Able to take oral medications; - Voluntarily participate and sign the willing to sign a consent form form, expected to have good compliance, and able to cooperate with the study according to the protocol requirements. Who Should NOT Join This Trial: - Currently participating in other clinical trials of drugs; - Patients who are pregnant or breastfeeding; - Other conditions deemed unsuitable for targeted therapy after multidisciplinary discussion; - Other conditions considered inappropriate for inclusion by the investigator, such as familial or social factors that may affect the safety of the subject or the collection of data. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Aged ≥18 years (inclusive), male or female; * Patients with histologically or cytologically confirmed locally advanced or metastatic melanoma; * Prior genetic testing results showing positive NRAS mutation; * Patients who have failed prior anti-PD-1/PD-L1 therapy; * Able to take oral medications; * Voluntarily participate and sign the informed consent form, expected to have good compliance, and able to cooperate with the study according to the protocol requirements. Exclusion Criteria: * Currently participating in other clinical trials of drugs; * Patients who are pregnant or breastfeeding; * Other conditions deemed unsuitable for targeted therapy after multidisciplinary discussion; * Other conditions considered inappropriate for inclusion by the investigator, such as familial or social factors that may affect the safety of the subject or the collection of data.

Treatments Being Tested

DRUG

tunlametinib

Tunlametinib will be administered at a dose of 12 mg orally, twice daily, continuously, in 4-week treatment cycles. Study treatment will continue until the occurrence of intolerable toxicity, PD, withdrawal of consent, initiation of new anti-tumor therapy, death, or when the investigator judges the risk outweighs the benefit, or the study is terminated/ends (whichever occurs first).

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China