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).
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Objective response rate — 3 years Defined as the percentage of subjects achieving Complete response (CR) or Partial response (PR) as assessed by RECIST 1.1
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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