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NCT06242522: FERTILAVE

Fertility and Pregnancy After Avelumab Treatment

Status unknown NA Last updated 15 March 2024
What this trial tests

NA trial testing Telephone interview in Gestational Trophoblastic Tumours in 50 participants. Status unknown.

Timeline
1 April 2024
Primary endpoint
1 April 2025
1 April 2025

Quick facts

Lead sponsorHospices Civils de Lyon
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment50
Start date1 April 2024
Primary completion1 April 2025
Estimated completion1 April 2025
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, female only, with Gestational Trophoblastic Tumours or Immune Checkpoint Inhibitors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The basic biology of NK cells and its application in tumor immunotherapy.
    Jiang P, Jing S, Sheng G, Jia F. · · 2024 · cited 17× · PMID 39221244 · DOI 10.3389/fimmu.2024.1420205
  2. The potential role of exercise in mitigating fertility toxicity associated with immune checkpoint inhibitors (ICIs) in cancer patients.
    Jamrasi P, Tazi M, Zulkifli NA, Bae JH, et al · · 2024 · cited 1× · PMID 39616333 · DOI 10.1186/s12576-024-00950-3

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Other trials of Telephone interview

Trials testing the same drug.

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06242522.

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