Clinical trial · Interventional
RWS of Tunlametinib in NRAS-Mutant Advanced Melanoma
A Prospective, Open-Label, Multicenter, Real-World Study to Evaluate the Efficacy and Safety of Tunlametinib in Patients With NRAS-Mutant Advanced Melanoma
NCT07445022CI-TRIAL-00104418recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma Advanced | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tunlametinib | Drug | Tunlametinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tunlametinib
- interventionNames
- Drug: tunlametinib
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 3 years
- description
- Defined as the percentage of subjects achieving Complete response (CR) or Partial response (PR) as assessed by RECIST 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.