MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 10
- 主要终点
- serum antimullerian hormone (AMH)
研究概览
简要总结
Melanoma survivorship in reproductive-age women is increasing due to the advent of effective therapies in the curative setting. However, while the impact on fertility and ovarian function of chemotherapy agents is well known, there is still a lack of consistent data regarding novel the Mitogen-activated protein kinase (MAP) kinase pathway inhibitors and immune-checkpoint inhibitors (ICIs) used in melanoma.
A recent study showed that a single course of anti-PD-1 (PD, Programmed cell death protein 1) or anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) reduced both the number and quality of oocytes in mice through an immune-mediated mechanism. In particular, primordial follicle damage cannot be restored, leading to relevant clinical implications.
The study aims to help to determine the impact of MAP kinase pathway inhibitors and ICIs on reproductive outcomes, and whether clinicians should discuss (and in what terms) fertility preservation techniques in reproductive-age women receiving ICIs and MAP kinase pathway inhibitors in the adjuvant setting.
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
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage II, III, IV completely resected melanoma
- •Under 40 years of age
- •Not previously treated with chemotherapy and/or radiotherapy
- •Being able to give written informed consent.
排除标准
- •Unresectable melanoma
- •Predisposing conditions for infertility
- •Early menopause or family history of early ovarian failure (idiopathic, < 45 years)
- •Previous bilateral ovariectomy or other ovarian surgery
- •Personal history of autoimmune diseases, endocrine disorders (except for hypothyroidism)
- •Personal history of severe mental disorders associated with infertility (e.g., nervous anorexia) and/or requiring treatments that could impair fertility
- •Inability to give written informed consent.
研究组 & 干预措施
Cohort A
BRAF/MEK inhibitors
干预措施: Dabrafenib + Trametinib (Drug)
Cohort B
Anti-PD-1
干预措施: Pembrolizumab (Drug)
Cohort B
Anti-PD-1
干预措施: Nivolumab (Drug)
Cohort C
Observation arm
干预措施: Observation (Other)
结局指标
主要结局
serum antimullerian hormone (AMH)
时间窗: 18 months after the start of therapy
To evaluate, in women of childbearing age, the variation in ovarian reserve after completion of adjuvant therapy with BRAF/MEK inhibitors or anti-PD-1 agents
次要结局
- To assess long-term fertility preservation after completion of adjuvant therapy To assess the early impact on fertilitY preservation of a short course of therapy(• AMH at 3 months after the start of adjuvant therapy • AMH at 12 months after the start of adjuvant therapy)