RWS of Tunlametinib in NRAS-Mutant Advanced Melanoma

ConditionMelanoma Advanced

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorFudan University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

tunlametinib
Drug
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).

Treatment groups

110 Participants

are divided into 1 treatment group

Group A: TunlametinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Objective response rate

Defined as the percentage of subjects achieving Complete response (CR) or Partial response (PR) as assessed by RECIST 1.1

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

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