A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART SWOG 1609) in Patients with Nonpancreatic Neuroendocrine Tumors.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
CTLA-4 Antigen
/ antagonists & inhibitors
Female
Follow-Up Studies
Humans
Ipilimumab
/ administration & dosage
Male
Middle Aged
Neuroendocrine Tumors
/ drug therapy
Nivolumab
/ administration & dosage
Prognosis
Programmed Cell Death 1 Receptor
/ antagonists & inhibitors
Prospective Studies
Rare Diseases
/ drug therapy
Survival Rate
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 05 2020
15 05 2020
Historique:
received:
14
10
2019
revised:
22
11
2019
accepted:
17
01
2020
pubmed:
24
1
2020
medline:
5
2
2021
entrez:
24
1
2020
Statut:
ppublish
Résumé
Immune checkpoint blockade has improved outcomes across tumor types; little is known about the efficacy of these agents in rare tumors. We report the results of the (nonpancreatic) neuroendocrine neoplasm cohort of SWOG S1609 dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART). We performed a prospective, open-label, multicenter phase II clinical trial of ipilimumab plus nivolumab across multiple rare tumor cohorts, with the (nonpancreatic) neuroendocrine cohort reported here. Response assessment by grade was not prespecified. The primary endpoint was overall response rate [ORR; RECIST v1.1; complete response (CR) and partial response (PR)]; secondary endpoints included progression-free survival (PFS), overall survival (OS), stable disease >6 months, and toxicity. Thirty-two eligible patients received therapy; 18 (56%) had high-grade disease. Most common primary sites were gastrointestinal (47%; Ipilimumab plus nivolumab demonstrated a 44% ORR in patients with nonpancreatic high-grade neuroendocrine carcinoma, with 0% ORR in low/intermediate grade disease.
Identifiants
pubmed: 31969335
pii: 1078-0432.CCR-19-3356
doi: 10.1158/1078-0432.CCR-19-3356
pmc: PMC7231627
mid: NIHMS1551456
doi:
Substances chimiques
CTLA-4 Antigen
0
CTLA4 protein, human
0
Ipilimumab
0
PDCD1 protein, human
0
Programmed Cell Death 1 Receptor
0
Nivolumab
31YO63LBSN
Banques de données
ClinicalTrials.gov
['NCT02834013']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2290-2296Subventions
Organisme : NCI NIH HHS
ID : UG1 CA189873
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180858
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233324
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180850
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233160
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189830
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189809
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA023100
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA073590
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180820
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180888
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189856
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233331
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189971
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA012644
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180834
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233329
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189821
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189870
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180821
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180801
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180819
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189953
Pays : United States
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
©2020 American Association for Cancer Research.
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