| Registry | NCT06242522, acronym FERTILAVE |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 50 (Estimated) |
| Sponsor | Hospices Civils de Lyon (Other) |
| Conditions | Gestational Trophoblastic Tumours, Immune Checkpoint Inhibitors |
| Interventions | Telephone interview (Other) |
| Dates | start 2024-04-01 (estimated), primary completion 2025-04-01 (estimated), completion 2025-04-01 (estimated), first posted 2024-02-05, last updated 2024-03-15 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Gestational Trophoblastic Tumours All trials for Immune Checkpoint Inhibitors All trials of Telephone interview
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Female patients with gestational trophoblastic tumour. | Other | Other: Telephone interview | 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. |
Sex: Female, ages: 18 Years to any
* 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
| Facility | City | Country | Status |
|---|---|---|---|
| Centre De Reference Des Maladies Trophoblastiques, Hôpital Lyon Sud | Pierre-Bénite | France |