Actively Recruiting
A Prospective, Open-Label, Multicenter, Real-World Study to Evaluate the Efficacy and Safety of Tunlametinib in Patients With NRAS-Mutant Advanced Melanoma
Led by Fudan University · Updated on 2026-03-03
110
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tunlametinib in patients with NRAS-mutant advanced melanoma who have not responded to previous anti-PD-1 or PD-L1 treatments. This prospective, open-label, multicenter real-world study focuses on understanding how this drug works in a real clinical setting for this specific patient group. Participants will receive tunlametinib orally at a dose of 12 mg twice daily in continuous 4-week cycles. Dose adjustments are allowed for managing side effects, with stepwise reductions from 12 mg to 9 mg and then 6 mg twice daily if needed. Imaging assessments will be done every 8 weeks to monitor the disease, and treatment will continue until disease progression, intolerable side effects, consent withdrawal, or other reasons decided by the investigator. After treatment ends, participants will enter a follow-up period including safety checks and survival monitoring. During the study, participants will be monitored regularly through imaging scans, vital signs, lab tests, and assessments of any side effects or additional treatments. Safety follow-up visits will occur 30 days after the last dose, and survival follow-up will continue every 3 months by phone or other means until death or study termination. The main outcome measured will be the objective response rate over 3 years, with participation lasting until treatment discontinuation and through the follow-up periods.
CONDITIONS
Brief Title
RWS of Tunlametinib in NRAS-Mutant Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, male or female
- Histologically or cytologically confirmed locally advanced or metastatic melanoma
- Prior genetic testing showing positive NRAS mutation
- Failed prior anti-PD-1/PD-L1 therapy
- Able to take oral medications
- Willing to participate voluntarily, sign informed consent, and comply with study requirements
You will not qualify if you...
- Currently participating in other drug clinical trials
- Pregnant or breastfeeding
- Conditions unsuitable for targeted therapy after multidisciplinary discussion
- Other factors deemed inappropriate by the investigator, including familial or social issues affecting safety or data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Variable duration until treatment discontinuation
Participants receive tunlametinib orally twice daily in continuous 4-week cycles until disease progression, intolerable toxicity, withdrawal, or other reasons for treatment discontinuation.
Imaging assessments every 8 weeks; dose adjustments as needed; treatment cycles repeated continuously
Duration - Safety follow-up for about 1 month, then survival follow-up continuing until death or loss to follow-up
After stopping treatment, participants undergo a safety follow-up visit about 30 days after last dose, then enter survival follow-up with visits every 3 months to collect survival and subsequent treatment information until death or loss to follow-up.
1 safety follow-up visit (in-person) and survival follow-up visits every 3 months (can be via telephone)
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Y
Yu Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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