A Prospective, Open-Label, Multicenter, Real-World Study to Evaluate the Efficacy and Safety of Tunlametinib in Patients With NRAS-Mutant Advanced Melanoma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
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.
详细描述
This study is a prospective, open-label, multicenter, real-world clinical study designed 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.
The study consists of a screening period (from the subject signing the informed consent form to enrollment, no more than 28 days), a treatment period (treatment discontinuation is defined as the inability to continue treatment for any reason, such as confirmed disease progression per imaging, intolerable toxicity despite dose adjustment, initiation of new anti-tumor therapy, death, or withdrawal for any reason), and treatment completion and follow-up period (including safety visits and survival follow-up).
Subjects' eligibility will be determined based on information collected within 28 days prior to enrollment. Subjects who meet the study criteria will enter the treatment period. This study plans to enroll 110 subjects with NRAS-mutant advanced melanoma:
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). Survival follow-up will continue after treatment discontinuation until the subject's death.
- Dose adjustments for tunlametinib are permitted and must be performed in a stepwise manner.
- In case of intolerance, the 12 mg dose should first be reduced to 9 mg twice daily, and then to 6 mg twice daily.
- Dose re-escalation depends on the specific situation. If tolerability improves significantly after dose reduction due to reasons such as AE intolerance, and the AE leading to dose reduction resolves to ≤ Grade 1 or baseline level, and no other intolerable toxicities occur after at least 6 weeks of treatment at the lower dose level, the previous dose level may be resumed. For example, if the dose is continuously reduced from 12 mg to 6 mg, re-escalation to 9 mg is recommended; re-escalation to 12 mg is generally not recommended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tunlametinib
干预措施: tunlametinib (Drug)
结局指标
主要结局
Objective response rate
时间窗: 3 years
Defined as the percentage of subjects achieving Complete response (CR) or Partial response (PR) as assessed by RECIST 1.1
次要结局
未报告次要终点
研究者
Yu Wang
Chief of Head and Neck Surgery
Fudan University