Gestational Trophoblastic Tumours, Immune Checkpoint Inhibitors
Conditions
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
Collection of gynaecology-obstetrics data on patients treated with AVELUMAB
Sponsors
Study design
Intervention model description
Prospective and retrospective cohort
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTT | Up to 5 years | Time to achieve pregnancy after stopping contraception |
Countries
France