Condition: Gestational Trophoblastic Neoplasias (GTN) · Sponsor: Hospices Civils de Lyon
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole. Low-risk GTN patients (FIGO score ≤ 6) are commonly treated with single agent treatment (methotrexate or actinomycin-D) The cure rate, assessed by hCG normalization, is obtained in 65 to 75% of patients with these agents GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens, such as EMA-CO or BEP regimen. Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating : * Spontaneous regressions of metastastic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells. * Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center. * Complete and durable responses to pembrolizumab were reported in 3 patients with multi-chemoresistant GTN in United Kingdom. * Three cases of hCG normalization with avelumab in 6 patients with chemo-resistant GTN…
This description comes directly from the study's public registry record.
Benoit YOU, MD · 33 4 78 864 318 · benoit.you@chu-lyon.fr
Laurent VILLENEUVE · 33 4 78 864 536 · laurent.villeneuve@chu-lyon.fr
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| Centre Hospitalier Lyon Sud | Pierre-Bénite, Pierre Bénite, France | Recruiting |
| Institut Bergonié | Bordeaux, France | Recruiting |
| Centre François Baclesse | Caen, France | Not Yet Recruiting |
| Centre Oscar Lambret | Lille, France | Not Yet Recruiting |
| Institut Paoli-Calmettes | Marseille, France | Not Yet Recruiting |
| Centre Antoine Lacassagne | Nice, France | Recruiting |
| Assistance Publique Hôpitaux de Paris | Paris, France | Recruiting |
| Centre Eugène Marquis | Rennes, France | Recruiting |
| Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04396223