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Clinical Trial NCT06242522 (FERTILAVE) for Gestational Trophoblastic Tumours, Immune Checkpoint Inhibitors is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Fertility and Pregnancy After Avelumab Treatment (FERTILAVE) 50 Immunotherapy

Not yet recruiting
Clinical Trial NCT06242522 (FERTILAVE) is an interventional study for Gestational Trophoblastic Tumours, Immune Checkpoint Inhibitors and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2024 and continue until the study accrues 50 participants. Led by Hospices Civils de Lyon, this study is expected to complete by 1 April 2025. The latest data from ClinicalTrials.gov was last updated on 15 March 2024.
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, a...Show More
Official Title

Fertility and Pregnancy After Avelumab Treatment

Conditions
Gestational Trophoblastic TumoursImmune Checkpoint Inhibitors
Other Study IDs
  • FERTILAVE
  • 69HCL24_0089
NCT ID Number
NCT06242522
Start Date (Actual)
2024-04-01
Last Update Posted
2024-03-15
Completion Date (Estimated)
2025-04-01
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Immune checkpoint inhibitors
Gestational trophoblastic tumours
Young women
Childbearing age
Pregnancy
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherFemale 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.
Telephone interview
Collection of gynaecology-obstetrics data on patients treated with AVELUMAB
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • Patient who has died
    • Patient who has had a hysterectomy
Hospices Civils de Lyon logoHospices Civils de Lyon
Study Central Contact
Contact: Pierre-Adrein BOLZE, ¨Pr, 04 78 86 66 78, [email protected]
Contact: Adrien MSIKA, [email protected]
1 Study Locations in 1 Countries
Centre De Reference Des Maladies Trophoblastiques, Hôpital Lyon Sud, Pierre-Bénite, 69310, France
Pierre-Adrien BOLZE, Pr, Contact, 04 78 86 66 78, [email protected]