Fertility and Pregnancy After Avelumab Treatment

Immune Checkpoint Inhibitors Clinical Trial

— FERTILAVE  

Official title:

Fertility and Pregnancy After Avelumab Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242522
• Other study ID #: 69HCL24_0089
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: Pierre-Adrein BOLZE, ¨Pr
• Phone: 04 78 86 66 78
• Email: pierre-adrien.bolze[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria :

• Patient aged over 18 years

• Have received AVELUMAB treatment for GTT in the TROPHIMMUN or TROPHAMET trials, or have received AVELUMAB outside the trial for gestational trophoblastic tumour.

• Did not object to participating in the study

• Exclusion Criteria :

• Patient who has died

• Patient who has had a hysterectomy

Related Conditions & MeSH terms

• Gestational Trophoblastic Disease
• Immune Checkpoint Inhibitors
• Trophoblastic Neoplasms

Intervention

Other:
• Telephone interview
Collection of gynaecology-obstetrics data on patients treated with AVELUMAB

Locations

Country	Name	City	State
France	Centre De Reference Des Maladies Trophoblastiques, Hôpital Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTT	Time to achieve pregnancy after stopping contraception	Up to 5 years