Prospective Evaluation of Clinical Outcomes in Patients With Resectable or Metastatic BRAF+ Melanoma Treated With Dabrafenib and Trametinib in Real Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- 12-month RFS rate
研究概览
简要总结
Prospective evaluation of clinical outcomes in patients with resectable or metastatic BRAF+ melanoma treated with dabrafenib and trametinib in real practice
详细描述
Rationale and background It is now accepted by the majority of experts in oncology that most effective and safe therapy options should be considered for first-line treatment, including adjuvant setting. As the routine administration of drugs including dosing, treatment interruptions, and early termination in clinical practice may vary from procedures used in clinical trials, post-authorization "real-world" data are important to quantify feasibility, acceptance, and practical considerations on prescription of targeted therapy with Dabrafenib+Trametinib. Therefore, it is of great interest for clinical and scientific communities to evaluate patient and treatment choice used in routine practice of Russian oncology centers. The aim of this study is to asses clinical outcomes of patient receiving Dab+Tram in different substages of resectable melanoma and different lines in metastatic melanoma., Additionally, it is of interest to gain insights into real world data regarding quality of life of melanoma patients treated with Dabrafenib and Trametinib in adjuvant or metastatic setting.
Research question and objectives Primary objective The primary objective in the study is to estimate relapse-free survival (RFS) in melanoma patients in adjuvant settings and progression free survival (PFS) in melanoma patients in metastatic settings. Primary endpoints
• The primary efficacy endpoint of the study is 12-month RFS rate, definded as the time form index date to the date of first documented relapse or death due to any cause.
The primary efficacy endpoint of the study is 12-month PFS rate, defined as the time from the index date to the date of the first documented progression by investigator judgement or death due to any cause. If a patient has not had an event, PFS will be censored at the date of the last tumor assessment
Secondary objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female patients aged 18 years or older;
- •Histologically confirmed stage III resectable or stage IV metastatic cutaneous melanoma with confirmed BRAF mutation, for whom the treating physician took the decision to initiate treatment with dabrafenib and trametinib before entering the study;
- •Treatment with Dabrafenib and Trametinib was initiated no longer than 4 weeks (28 days) prior to written informed consent for this study;
- •Performance status ≤ 2 by Eastern Cooperative Oncology Group (ECOG) scale;
- •Patient is willing and able to participate in the study;
- •Written informed consent for study participation.
排除标准
- •Patients with a life expectancy of less than 3 months at the time of melanoma diagnosis, per the investigator's judgment.
- •Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated or other non-interventional study [NIS] can be included as long as their standard of care is not altered by the study).
- •Patients on active treatment for malignancies other than melanoma at the time of enrollment.
研究组 & 干预措施
Adjuvant cohort
Patients with resectable stage III melanoma, reciveng dabrafenib and trametinib in adjuvant settings
干预措施: Dabrafenib (Drug)
Adjuvant cohort
Patients with resectable stage III melanoma, reciveng dabrafenib and trametinib in adjuvant settings
干预措施: Trametinib (Drug)
Metastatic cohort
Patients with unresectable stage IIIC/D or stage IV melanoma, reciveng dabrafenib and trametinib in metastatic settings
干预措施: Dabrafenib (Drug)
Metastatic cohort
Patients with unresectable stage IIIC/D or stage IV melanoma, reciveng dabrafenib and trametinib in metastatic settings
干预措施: Trametinib (Drug)
结局指标
主要结局
12-month RFS rate
时间窗: 12 months
The primary efficacy endpoint of the study is 12-month RFS rate, definded as the time form index date to the date of first documented relapse or death due to any cause
12-month PFS rate
时间窗: 12 months
The primary efficacy endpoint of the study is 12-month PFS rate, defined as the time from the index date to the date of the first documented progression by investigator judgement or death due to any cause. If a patient has not had an event, PFS will be censored at the date of the last tumor assessment
次要结局
- To describe patient populations receiving dabrafenib and trametinib for stage III resectable melanoma with respect to demographics and clinical characteristics at index date (baseline).(12 months)
- To describe patient populations receiving dabrafenib and trametinib for stage IV metastatic melanoma with respect to demographics and clinical characteristics at index date (baseline)(12 months)
- Evaluate retrospectively the sequence of therapy prior to initiating treatment with Dabrafenib and Trametinib(12 months)
- Analyze prospectively treatment options following disease recurrence or progression on treatment with Dabrafenib and Trametinib(12 months)
- Analyze proportion (%) of patients receiving adjuvant therapy with Dabrafenib and Trametinib for melanoma stage IIIA/IIIB/IIIC/IIID(12 months)
- Analyze proportion (%) of patients receiving Dabrafenib and Trametinib in 1L/2L/3L/later lines in metastatic settings(12 months)
- To assess treatment duration in melanoma patients treated with Dabrafenib and Trametinib in adjuvant settings in real-world practice(12 months)
- To assess treatment discontinuation rat in melanoma patients treated with Dabrafenib and Trametinib in adjuvant settings in real-world practice(12 months)
- To assess median PFS in melanoma patients treated with Dabrafenib and Trametinib in metastatic settings in real-world practice(12 months)
- To assess median treatment duration in melanoma patients treated with Dabrafenib and Trametinib in metastatic settings in real-world practice(12 months)
- To assess treatment discontinuation rate in melanoma patients treated with Dabrafenib and Trametinib in metastatic settings in real-world practice(12 months)
- To assess rate of adverse events associated with the therapy of interest(12 months)
- To assess proportions of patients and reasons of dose adjustment on dabrafenib and trametinib in melanoma patients treated with Dabrafenib and Trametinib in adjuvant and metastatic in real-world practice(12 months)
- Description of changes in patient-reported symptoms and quality of life (QoL) in melanoma patients treated with Dabrafenib and Trametinib in real-world setting(12 months)