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RECRUITING
NCT07445022
PHASE4

RWS of Tunlametinib in NRAS-Mutant Advanced Melanoma

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-01-28

Completion Date

2029-01-31

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

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