NCT06242522

Fertility and Pregnancy After Avelumab Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gestational Trophoblastic Tumours
• Immune Checkpoint Inhibitors

Interventions

Type	Name	Description
OTHER	Telephone interview	Collection of gynaecology-obstetrics data on patients treated with AVELUMAB

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-02-05
• Last updated: 2024-03-15

Locations

1 site across 1 country: France