RWS of Tunlametinib in NRAS-Mutant Advanced Melanoma
Recruiting · NCT07445022 · Interventional (participants receive a specific treatment) · Lead sponsor: Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Fudan University Shanghai Cancer Center - Shanghai, China