Fertility and Pregnancy After Avelumab Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Gestational Trophoblastic Tumours Immune Checkpoint Inhibitors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective and retrospective cohort

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Telephone interview

Intervention Type OTHER

Collection of gynaecology-obstetrics data on patients treated with AVELUMAB

Interventions

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Telephone interview

Collection of gynaecology-obstetrics data on patients treated with AVELUMAB

Intervention Type OTHER

Eligibility Criteria

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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