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Fertility and Pregnancy After Avelumab Treatment

Fertility and Pregnancy After Avelumab Treatment

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06242522
Acronym
FERTILAVE
Enrollment
50
Registered
2024-02-05
Start date
2024-04-01
Completion date
2025-04-01
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Trophoblastic Tumours, Immune Checkpoint Inhibitors

Keywords

Immune checkpoint inhibitors, Gestational trophoblastic tumours, Young women, Childbearing age, Pregnancy

Brief 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.

Interventions

OTHERTelephone interview

Collection of gynaecology-obstetrics data on patients treated with AVELUMAB

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Prospective and retrospective cohort

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTTUp to 5 yearsTime to achieve pregnancy after stopping contraception

Countries

France

Contacts

Primary ContactPierre-Adrein BOLZE, ¨Pr
pierre-adrien.bolze@chu-lyon.fr04 78 86 66 78
Backup ContactAdrien MSIKA
adrien.msika@chu-lyon.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026