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临床试验/NCT04045691
NCT04045691招募中不适用

Encorafenib Plus Binimetinib in Patients With Locally Advanced, Unresectable or Metastatic BRAFV600-mutated Melanoma: a Multi-centric, Multinational, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland - BERING MELANOMA

Pierre Fabre Pharma GmbH59 个研究点 分布在 2 个国家目标入组 750 人开始时间: 2019年10月17日最近更新:
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适应症
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
750
试验地点
59
主要终点
Progression-free survival
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

BERING-MELANOMA - designed as a prospective, longitudinal, non-interventional study - investigates real-world effectiveness, quality of life, safety and tolerability of encorafenib plus binimetinib in unresectable advanced or metastatic BRAF(Rapidly Accelerated Fibrosarcoma isoform B)-V600-mutant malignant melanoma after commercial availability of these two products in Germany, Austria and Switzerland. The study focusses on the documentation of the first and second line setting (i.e. after one line of prior checkpoint inhibition) by documenting patients treated according to the SmPC (Summary of Product Characteristics).

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

  • •Written informed consent of the patient with regard to the pseudonymized documentation as well as the transfer and processing of his/her data within the study and the ADOREG [Cancer Registry of German Working Group of Dermato-Oncology] registry (data transfer to ADOREG registry only for patients from German sites);
  • •Legally capable male or female patient ≥ 18 years of age (no upper limit);
  • •Decision was taken to treat the patient with encorafenib plus binimetinib in accordance with the current SmPC [Summary of Product Characteristics] and by prescription; this decision was taken prior to and independent from the inclusion into the study;
  • •Treatment with encorafenib plus binimetinib has been started ≤ 6 months prior to providing written informed consent for this study or is planned to be started in the near future;
  • •Unresectable advanced or metastatic malignant melanoma with BRAF [Rapidly Accelerated Fibrosarcoma isoform B] V600 mutation;
  • •Treatment-naive or after one prior line of checkpoint inhibitor treatment (anti-CTLA4 [Cytotoxic T-Lymphocyte Antigen-4] and/or anti-PD(L)1 [Programmed cell Death protein 1]) in the unresectable advanced or metastatic setting.

排除标准

  • •Previous treatment with a BRAF- and/or MEK [Mitogen-Activated Protein/Extracellular-signal Regulated Kinase]- inhibitor except for:
  • •- prior adjuvant treatment with BRAF+MEK-inhibitor combination therapy that ended > 6 months prior start of Encorafenib/Binimetinib treatment;
  • •More than one prior line of checkpoint inhibitor treatment in the unresectable advanced or metastatic setting;
  • •Any previous chemotherapeutic treatment of the melanoma disease;
  • •Presence of any contraindication with regard to the encorafenib-binimetinib-treatment as specified in the corresponding SmPCs;
  • •Current or upcoming participation in an interventional clinical trial;
  • •Current or upcoming systemic treatment of any other tumor than melanoma;
  • •Prisoners or persons who are compulsorily detained (involuntarily incarcerated).

结局指标

主要结局

Progression-free survival

时间窗: At 12 months after start of treatment

Progression-free survival rate

次要结局

  • Type of treatments before and after encorafenib plus binimetinib(Complete observation time-frame (the total observation period of this study will amount to 90 months).)
  • Patient and disease profiles at start of treatment with encorafenib plus binimetinib(Baseline)
  • Patient reported outcomes during treatment with encorafenib plus binimetinib - evaluated with EORTC QLQ C-30(From start to end of treatment (anticipated median treatment duration ca. 12 months))
  • Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with WPAI(From start to end of treatment (anticipated median treatment duration ca. 12 months))
  • Sequence of treatments before and after encorafenib plus binimetinib(Complete observation time-frame (the total observation period of this study will amount to 90 months).)
  • Characteristics of treatment with encorafenib plus binimetinib(From start to end of treatment (anticipated median treatment duration ca. 12 months))
  • Effectiveness of treatment with encorafenib plus binimetinib(Complete observation time-frame (the total observation period of this study will amount to 90 months).)
  • Patient reported outcomes during treatment with encorafenib plus binimetinib evaluated with CTSQ(From start to end of treatment (anticipated median treatment duration ca. 12 months))
  • Physicians' satisfaction with regard the treatment with encorafenib plus binimetinib(From start to end of treatment (anticipated median treatment duration ca. 12 months))
  • Safety and tolerability of treatment with encorafenib plus binimetinib - Adverse events and adverse reactions including time to onset and time to resolution(Complete observation time-frame (the total observation period of this study will amount to 90 months).)
  • Prognostic factors(Complete observation time-frame (the total observation period of this study will amount to 90 months).)
  • Treatment duration(From start to end of treatment (anticipated median treatment duration ca. 12 months))
  • Treatment dose intensity(From start to end of treatment (anticipated median treatment duration ca. 12 months))
  • Number of treatment interruptions(From start to end of treatment (anticipated median treatment duration ca. 12 months))
  • Duration of treatment interruptions(From start to end of treatment (anticipated median treatment duration ca. 12 months))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (59)

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