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Avelumab in paediatric patients with refractory or relapsed solid tumours: dose-escalation results from an open-label, single-arm, phase 1/2 trial
DC Field | Value | Language |
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dc.contributor.author | Loeb, David M. | - |
dc.contributor.author | Lee, Ji Won | - |
dc.contributor.author | Morgenstern, Daniel A. | - |
dc.contributor.author | Samson, Yvan | - |
dc.contributor.author | Uyttebroeck, Anne | - |
dc.contributor.author | Lyu, Chuhl Joo | - |
dc.contributor.author | Van Damme, An | - |
dc.contributor.author | Nysom, Karsten | - |
dc.contributor.author | Macy, Margaret E. | - |
dc.contributor.author | Zorzi, Alexandra P. | - |
dc.contributor.author | Xiong, Julia | - |
dc.contributor.author | Pollert, Petra | - |
dc.contributor.author | Joerg, Ingrid | - |
dc.contributor.author | Vugmeyster, Yulia | - |
dc.contributor.author | Ruisi, Mary | - |
dc.contributor.author | Kang, Hyoung Jin | - |
dc.date.accessioned | 2022-06-24T07:03:05Z | - |
dc.date.available | 2022-06-24T07:03:05Z | - |
dc.date.created | 2022-05-10 | - |
dc.date.issued | 2022-01 | - |
dc.identifier.citation | Cancer Immunology, Immunotherapy | - |
dc.identifier.issn | 0340-7004 | - |
dc.identifier.uri | https://hdl.handle.net/10371/184000 | - |
dc.description.abstract | © 2022, The Author(s).Background: We report dose-escalation results from an open-label, phase 1/2 trial evaluating avelumab (anti-PD-L1) in paediatric patients with refractory/relapsed solid tumours. Methods: In phase 1, patients aged < 18 years with solid (including central nervous system [CNS]) tumours for which standard therapy did not exist or had failed were enrolled in sequential cohorts of 3–6 patients. Patients received avelumab 10 or 20 mg/kg intravenously every 2 weeks. Primary endpoints were dose-limiting toxicities (DLTs) and grade ≥ 3 treatment-emergent adverse events (AEs). Results: At data cut-off (27 July 2021), 21 patients aged 3–17 years had received avelumab 10 mg/kg (n = 6) or 20 mg/kg (n = 15). One patient had three events that were classified as a DLT (fatigue with hemiparesis and muscular weakness associated with pseudoprogression; 20 mg/kg cohort). Grade ≥ 3 AEs occurred in five (83%) and 11 (73%) patients in the 10 and 20 mg/kg cohorts, respectively, and were treatment-related in one patient (7%; grade 3 [DLT]) in the 20 mg/kg cohort. Avelumab exposure in paediatric patients receiving 20 mg/kg dosing, but not 10 mg/kg, was comparable or higher compared with approved adult dosing (10 mg/kg or 800 mg flat dose). No objective responses were observed. Four patients with CNS tumours (20 mg/kg cohort) achieved stable disease, which was ongoing in two patients with astrocytoma at cut-off (for 24.7 and 30.3 months). Conclusion: In paediatric patients with refractory/relapsed solid tumours, avelumab monotherapy showed a safety profile consistent with previous adult studies, but clinical benefits were limited. | - |
dc.language | 영어 | - |
dc.publisher | Springer Verlag | - |
dc.title | Avelumab in paediatric patients with refractory or relapsed solid tumours: dose-escalation results from an open-label, single-arm, phase 1/2 trial | - |
dc.type | Article | - |
dc.identifier.doi | 10.1007/s00262-022-03159-8 | - |
dc.citation.journaltitle | Cancer Immunology, Immunotherapy | - |
dc.identifier.wosid | 000766436700001 | - |
dc.identifier.scopusid | 2-s2.0-85125851110 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kang, Hyoung Jin | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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