A phase I study of the safety and efficacy of talimogene laherparepvec in Japanese patients with advanced melanoma.
Japanese
immunotherapy
melanoma
phase I clinical trial
talimogene laherparepvec
Journal
Cancer science
ISSN: 1349-7006
Titre abrégé: Cancer Sci
Pays: England
ID NLM: 101168776
Informations de publication
Date de publication:
Aug 2022
Aug 2022
Historique:
revised:
11
05
2022
received:
03
03
2022
accepted:
23
05
2022
pubmed:
4
6
2022
medline:
10
8
2022
entrez:
3
6
2022
Statut:
ppublish
Résumé
Talimogene laherparepvec (T-VEC) is approved for the treatment of unresectable melanoma in the USA, Europe, and Australia. This phase I, multicenter, open-label, dose de-escalation study evaluated the safety and efficacy of T-VEC in Japanese patients with unresectable stage IIIB-IV melanoma. Eligible adult patients had histologically confirmed stage IIIB-IVM1c cutaneous melanoma, may have received prior systemic anticancer therapy, must have had ≥1 injectable lesion, serum lactate dehydrogenase ≤1.5x upper limit of normal, ECOG performance status of 0 or 1, and adequate hematologic, hepatic, and renal function. T-VEC was injected intralesionally (first dose, ≤4.0 ml of 10
Identifiants
pubmed: 35656636
doi: 10.1111/cas.15450
pmc: PMC9357627
doi:
Substances chimiques
Biological Products
0
talimogene laherparepvec
0
Types de publication
Clinical Trial, Phase I
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
2798-2806Subventions
Organisme : Amgen Inc.
Informations de copyright
© 2022 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.
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