Mogamulizumab in Combination with Nivolumab in a Phase I/II Study of Patients with Locally Advanced or Metastatic Solid Tumors.
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Female
Humans
Immune Checkpoint Inhibitors
/ administration & dosage
Infusions, Intravenous
Male
Middle Aged
Neoplasms
/ drug therapy
Nivolumab
/ administration & dosage
Progression-Free Survival
Safety
Treatment Outcome
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
01 02 2022
01 02 2022
Historique:
received:
30
07
2021
revised:
04
10
2021
accepted:
04
11
2021
pubmed:
11
11
2021
medline:
23
3
2022
entrez:
10
11
2021
Statut:
ppublish
Résumé
The aim of the study was to determine safety, antitumor activity, and pharmacodynamic profile of mogamulizumab, an anti-CCR4 monoclonal antibody targeting effector regulatory T cells (Treg) in combination with the checkpoint inhibitor nivolumab in patients with locally advanced or metastatic solid tumors. This was a multicenter, dose-finding (phase I), and dose expansion (phase II) study (NCT02705105) in patients with locally advanced or metastatic solid tumors. There were no dose-limiting toxicities in phase I with mogamulizumab 1 mg/kg every week for cycle 1 followed by 1 mg/kg every 2 weeks plus nivolumab 240 mg every 2 weeks intravenously, and cohort expansion occurred at this dose level. All 114 patients treated with mogamulizumab 1 mg/kg plus nivolumab 240 mg in phases I ( Combination of mogamulizumab with nivolumab for treatment of patients with locally advanced or metastatic solid tumors did not result in enhanced efficacy. Tolerability of mogamulizumab 1 mg/kg plus nivolumab 240 mg was acceptable.
Identifiants
pubmed: 34753777
pii: 1078-0432.CCR-21-2781
doi: 10.1158/1078-0432.CCR-21-2781
pmc: PMC9401557
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Immune Checkpoint Inhibitors
0
Nivolumab
31YO63LBSN
mogamulizumab
YI437801BE
Types de publication
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
479-488Informations de copyright
©2021 The Authors; Published by the American Association for Cancer Research.
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