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临床试验/NCT06242522
NCT06242522尚未招募不适用

Fertility and Pregnancy After Avelumab Treatment

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
2
主要终点
Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTT

研究概览

简要总结

Immune checkpoint inhibitors (ICIs), such as anti-PD-1/PD-L1 agents, initially evaluated in advanced non-curative pathologies, are now being evaluated in adjuvant or even neoadjuvant curative treatment conditions. This paradigm shift is leading to the treatment of young women, particularly in the context of gestational trophoblastic tumours. Given the potential autoimmune side-effects affecting endocrine functions, as well as their impact on maternal-foetal tolerance mechanisms, accurate assessment of post-ICT fertility is necessary. In the coming years, treatment with anti-PD-L1 (avelumab) could become a cornerstone of the therapeutic strategy for patients with gestational trophoblastic tumours.

However, these patients are often young and of childbearing age, so safety of use in terms of fertility and successful pregnancies is an essential factor in the widespread use of immunotherapy as a treatment option. Some studies have reported the possibility of conceiving after avelumab treatment, but no cohort has been reported. This study aims to explore fertility and the course of potential pregnancy in 50 patients treated with anti-PD-L1 (avelumab) over the last 5 years in several French centres.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Female patients with gestational trophoblastic tumour.

Other

Female patients treated in phase II or III clinical trials: TROPHIMMUN and TROPHAMET or who have received AVELUMAB outside the trial for a gestational trophoblastic tumour.

干预措施: Telephone interview (Other)

结局指标

主要结局

Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTT

时间窗: Up to 5 years

Time to achieve pregnancy after stopping contraception

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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