NCT07445022

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
31mo left

Started Jan 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Jan 2029

Study Start

First participant enrolled

January 28, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

February 25, 2026

Last Update Submit

February 25, 2026

Conditions

Melanoma Advanced

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

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

    3 years

Study Arms (1)

Tunlametinib

EXPERIMENTAL
Drug: tunlametinib

Interventions

tunlametinibDRUG

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).

Tunlametinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Currently participating in other clinical trials of drugs;
  • Patients who are pregnant or breastfeeding;
  • Other conditions deemed unsuitable for targeted therapy after multidisciplinary discussion;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Central Study Contacts

Yu Wang

CONTACT

86-021-64175590neck130@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Head and Neck Surgery

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

January 28, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

CN(1)