Fertility and Pregnancy After Avelumab Treatment

NCT06242522 | Not Yet Recruiting

• 1 other identifier: 69HCL24_0089
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Trophoblastic Tumours; Immune Checkpoint Inhibitors

Keywords

Immune checkpoint inhibitors; Gestational trophoblastic tumours; Young women; Childbearing age; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Describe the time to pregnancy in patients treated with anti PDL1 (avelumab) for GTT

  Time to achieve pregnancy after stopping contraception

  Up to 5 years

Study Arms (1)

Female patients with gestational trophoblastic tumour.

OTHER

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.

Other: Telephone interview

Interventions

Telephone interview OTHER

Collection of gynaecology-obstetrics data on patients treated with AVELUMAB

Female patients with gestational trophoblastic tumour.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient who has died
• Patient who has had a hysterectomy

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre De Reference Des Maladies Trophoblastiques, Hôpital Lyon Sud

Pierre-Bénite, 69310, France

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Pierre-Adrein BOLZE, ¨Pr

CONTACT

04 78 86 66 78; pierre-adrien.bolze@chu-lyon.fr

Adrien MSIKA

CONTACT

adrien.msika@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective and retrospective cohort

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 5, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)