KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma.
chemotherapy
esophageal adenocarcinoma
esophageal cancer
esophageal squamous cell carcinoma
immunotherapy
pembrolizumab
radiotherapy
Journal
Future oncology (London, England)
ISSN: 1744-8301
Titre abrégé: Future Oncol
Pays: England
ID NLM: 101256629
Informations de publication
Date de publication:
Apr 2021
Apr 2021
Historique:
pubmed:
4
2
2021
medline:
16
10
2021
entrez:
3
2
2021
Statut:
ppublish
Résumé
Despite curative-intent treatment, most patients with locally advanced esophageal cancer will experience disease recurrence or locoregional progression, highlighting the need for new therapies. Current guidelines recommend definitive chemoradiotherapy in patients ineligible for surgical resection, but survival outcomes are poor. Pembrolizumab is well tolerated and provides promising antitumor activity in patients with previously treated, advanced, unresectable esophageal/esophagogastric junction cancer. Combining pembrolizumab with chemoradiotherapy may further improve outcomes in the first-line setting. Here, we describe the design and rationale for the double-blind, Phase III, placebo-controlled, randomized KEYNOTE-975 trial investigating pembrolizumab in combination with definitive chemoradiotherapy as first-line treatment in patients with locally advanced, unresectable esophageal/gastroesophageal junction cancer. Overall survival and event-free survival are the dual primary end points.
Identifiants
pubmed: 33533655
doi: 10.2217/fon-2020-0969
pmc: PMC7927908
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
pembrolizumab
DPT0O3T46P
Banques de données
ClinicalTrials.gov
['NCT04210115']
Types de publication
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1143-1153Subventions
Organisme : NCI NIH HHS
ID : R01 CA228512
Pays : United States
Organisme : Merck Sharp and Dohme
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