- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06242522
Fertility and Pregnancy After Avelumab Treatment (FERTILAVE)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre-Adrein BOLZE, ¨Pr
- Phone Number: +33 04 78 86 66 78
- Email: pierre-adrien.bolze@chu-lyon.fr
Study Contact Backup
- Name: Adrien MSIKA
- Email: adrien.msika@chu-lyon.fr
Study Locations
-
-
-
Pierre-Bénite, France, 69310
- Centre De Reference Des Maladies Trophoblastiques, Hôpital Lyon Sud
-
Contact:
- Pierre-Adrien BOLZE, Pr
- Phone Number: +33 04 78 86 66 78
- Email: pierre-adrien.bolze@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Female patients with gestational trophoblastic tumour.
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.
|
Collection of gynaecology-obstetrics data on patients treated with AVELUMAB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTT
Time Frame: Up to 5 years
|
Time to achieve pregnancy after stopping contraception
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL24_0089
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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