Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study).
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:
15 Sep 2019
15 Sep 2019
Historique:
received:
19
09
2018
revised:
02
04
2019
accepted:
20
05
2019
pubmed:
28
5
2019
medline:
26
9
2019
entrez:
26
5
2019
Statut:
ppublish
Résumé
Limited options exist for patients with advanced pancreatic cancer progressing after 1 or more lines of therapy. A phase II study in patients with previously treated metastatic pancreatic cancer showed that combining GVAX pancreas (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated Patients with previously treated metastatic pancreatic adenocarcinoma were randomized 1:1:1 to receive Cy/GVAX + CRS-207 (arm A), CRS-207 (arm B), or physician's choice of single-agent chemotherapy (arm C). The primary cohort included patients who had failed ≥2 prior lines of therapy, including gemcitabine. The primary objective compared OS between arms A and C in the primary cohort. The second-line cohort included patients who had received 1 prior line of therapy. Additional objectives included OS between all treatment arms, safety, and tumor responses. The study did not meet its primary efficacy endpoint. At the final study analysis, median OS [95% confidence interval (CI)] in the primary cohort ( The combination of Cy/GVAX + CRS-207 did not improve survival over chemotherapy. (ClinicalTrials.gov ID: NCT02004262)
Identifiants
pubmed: 31126960
pii: 1078-0432.CCR-18-2992
doi: 10.1158/1078-0432.CCR-18-2992
pmc: PMC7376746
mid: NIHMS1606697
doi:
Substances chimiques
Granulocyte-Macrophage Colony-Stimulating Factor
83869-56-1
Cyclophosphamide
8N3DW7272P
Banques de données
ClinicalTrials.gov
['NCT02004262']
Types de publication
Journal Article
Comment
Langues
eng
Sous-ensembles de citation
IM
Pagination
5493-5502Subventions
Organisme : NCI NIH HHS
ID : P50 CA062924
Pays : United States
Commentaires et corrections
Type : CommentIn
Type : CommentOn
Informations de copyright
©2019 American Association for Cancer Research.
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