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Trial Title:
Fertility and Pregnancy After Avelumab Treatment
NCT ID:
NCT06242522
Condition:
Gestational Trophoblastic Tumours
Immune Checkpoint Inhibitors
Conditions: Official terms:
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Conditions: Keywords:
Immune checkpoint inhibitors
Gestational trophoblastic tumours
Young women
Childbearing age
Pregnancy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Prospective and retrospective cohort
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Telephone interview
Description:
Collection of gynaecology-obstetrics data on patients treated with AVELUMAB
Arm group label:
Female patients with gestational trophoblastic tumour.
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre De Reference Des Maladies Trophoblastiques, Hôpital Lyon Sud
Address:
City:
Pierre-Bénite
Zip:
69310
Country:
France
Contact:
Last name:
Pierre-Adrien BOLZE, Pr
Phone:
04 78 86 66 78
Phone ext:
+33
Email:
pierre-adrien.bolze@chu-lyon.fr
Start date:
April 1, 2024
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Hospices Civils de Lyon
Agency class:
Other
Source:
Hospices Civils de Lyon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06242522
