RecruitingPhase 4NCT07445022

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


Sponsor

Fudan University

Enrollment

110 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world study is collecting data on how well a drug called tunlametinib works in people with advanced melanoma (a type of skin cancer) that has a specific genetic change called an NRAS mutation. Unlike a controlled clinical trial, this is a registry study observing patients receiving this treatment as part of their regular cancer care. **You may be eligible if:** - You are 18 years of age or older - You have been diagnosed with locally advanced or metastatic melanoma, confirmed by lab testing - Your tumor has tested positive for an NRAS mutation - You have already received and not responded to immunotherapy (anti-PD-1/PD-L1 drugs) - You are able to take oral medications **You may NOT be eligible if:** - You are currently enrolled in another clinical drug trial - You are pregnant or breastfeeding - Your doctors have decided that targeted therapy is not appropriate for you - There are other personal or social factors that make participation unsafe or impractical Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGtunlametinib

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07445022