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Avelumab and Methotrexate in in Low-risk Gestational Trophoblastic Neoplasias as First Line Treatment

Study acronym: TROPHAMET
StatusRecruiting
PhasePhase 1/2
Started2020-02-12
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 29, 2024 (before its estimated April 12, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2024-02-28
Study Status, Contacts/Locations v2
Primary completion date2023-06-12→2025-04-12
Completion date2026-07-12→2028-10-12
Study sites8→9
2020-05-20
Study Status, Study Description, Outcome Measures v1
Secondary endpoints5 entries, revised
Evaluate the safety of methotrexate and avelumab combinaisoncombination administration
Primary endpoints2 entries, revised
Incidence of Dose limiting toxicities of methotrexate and avelumab combinaisoncombination in low-risk GTN patients as first line.
2020-05-15
Original filing
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 enrolled in TROPHIMMUN cohort A (resistant to a mono-chemotherapy). * Cytotoxicity of avelumab is mediated through antibody dependent cell cytotoxicity (ADCC) by NK cells.
Trial Details
NCT Number NCT04396223
Lead Sponsor Hospices Civils de Lyon
Collaborators: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions Gestational Trophoblastic Neoplasias (GTN)
Enrollment 26 participants
Start Date 2020-02-12
Primary Completion 2025-04-12 (estimated)
Study Completion 2028-10-12 (estimated)
Updated on ClinicalTrials.gov 2024-02-29