Evidence map›Paper›PMID 23924790›Full record

Trial reportJournal of immunotherapy (Hagerstown, Md. : 1997)2013

Evaluation of ipilimumab in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in previously treated pancreatic cancer.

Dung T Le, Eric Lutz, Jennifer N Uram, Elizabeth A Sugar, Beth Onners, Sara Solt, Lei Zheng, Luis A Diaz, Ross C Donehower, Elizabeth M Jaffee and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of immunotherapy (Hagerstown, Md. : 1997), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00836407 (A Phase Ib Trial Evaluating the Safety and Feasibility of Ipilimumab), which is not on this map. Cited by 339 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
339citing papers in PubMed, 5 pooled it
22.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00836407 phase1completednot on this map

A Phase Ib Trial Evaluating the Safety and Feasibility of Ipilimumab (BMS-734016) Alone or in Combination With Allogeneic Pancreatic Tumor Cells Transfected With a GM-CSF Gene for the Treatment of Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2009 to 2012Enrolled30ConditionsPancreatic CancerArmsIpilimumab, Pancreatic Cancer Vaccine
3 · Its place in the literature

Who cites it

339 citing papers in PubMed, 5 syntheses or guidelines pooled it, 550 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
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  10. Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Trial
  11. Trial
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  14. A Phase II Trial of Pembrolizumab plus Granulocyte-Macrophage Colony-Stimulating Factor in Advanced Biliary Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
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  16. Review
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279 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Dung T LeThe Sidney Kimmel Cancer Center, the Skip Viragh Center for Pancreatic Cancer, Research and Clinical Care, and the Sol Goldman Pancreatic Cancer Center at Johns Hopkins, Baltimore, MD, USA. dle2@jhmi.edu
Eric Lutz
Jennifer N Uram
Elizabeth A Sugar
Beth Onners
Sara Solt
Lei Zheng
Luis A Diaz
Ross C Donehower
Elizabeth M Jaffee
Daniel A Laheru
Sidney Kimmel Cancer Center · USSidney Kimmel Comprehensive Cancer Center · USSwim Across America · US

Funding

Tumor Antigens for Individual Signatures and TherapyP50CA062924 · NCI · JOHNS HOPKINS UNIVERSITY · PI KERN, SCOTT E · 1993 to 2022
$54.6M
Interrogate the interaction between tumor cells and nerves in the tumor microenvironment of pancreatic cancerR01CA169702 · NCI · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · PI ZHENG, LEI · 2013 to 2023
$3.6M
Dissecting the mechanisms of immune tolerance within the pancreatic tumor's microK23CA148964 · NCI · JOHNS HOPKINS UNIVERSITY · PI ZHENG, LEI · 2010 to 2014
$888k
Cyclophosphamide modified GM-CSF pancreatic tumor vaccine + listeria-mesothelinK23CA163672 · NCI · JOHNS HOPKINS UNIVERSITY · PI LE, DUNG T · 2012 to 2015
$715k
Gene modified vaccine in combination with Ipilimumab for advanced pancreatic cancR21CA126058 · NCI · JOHNS HOPKINS UNIVERSITY · PI LAHERU, DANIEL A · 2008 to 2009
$661k
NCI NIH HHS 2P50 CA062924NCI NIH HHS K23 CA148964NCI NIH HHS K23 CA163672NCI NIH HHS P50 CA062924NCI NIH HHS R01 CA169702NCI NIH HHS R21 CA126058NCI NIH HHS R21 CA1266058
6 · The paper itself

Abstract

Preclinical reports support the concept of synergy between cancer vaccines and immune checkpoint blockade in nonimmunogenic tumors. In particular, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies have been successfully combined with GM-CSF cell-based vaccines (GVAX). Ipilimumab (anti-CTLA-4) has been tested as a single agent in patients with pancreatic ductal adenocarcinoma (PDA) resulting in a delayed response at a dose of 3 mg/kg. Our study evaluated ipilimumab 10 mg/kg (arm 1) and ipilimumab 10 mg/kg + GVAX (arm 2). A total of 30 patients with previously treated advanced PDA were randomized (1:1). Induction doses were administered every 3 weeks for a total of 4 doses followed by maintenance dosing every 12 weeks. Two patients in arm 1 showed evidence of stable disease (7 and 22 wk) but none demonstrated CA19-9 biochemical responses. In contrast, 3 patients in arm 2 had evidence of prolonged disease stabilization (31, 71, and 81 wk) and 7 patients experienced CA19-9 declines. In 2 of these patients, disease stabilization occurred after an initial period of progression. The median overall survival (OS) (3.6 vs. 5.7 mo, hazards ratio: 0.51, P = 0.072) and 1 year OS (7 vs. 27%) favored arm 2. Similar to prior ipilimumab studies, 20% of patients in each arm had grade 3/4 immune-related adverse events. Among patients with OS > 4.3 months, there was an increase in the peak mesothelin-specific T cells (P = 0.014) and enhancement of the T-cell repertoire (P = 0.031). In conclusion, checkpoint blockade in combination with GVAX has the potential for clinical benefit and should be evaluated in a larger study.

Indexed as

AdultAgedAntibodies, MonoclonalAntineoplastic AgentsCancer VaccinesCarcinoma, Pancreatic DuctalCombined Modality TherapyCTLA-4 AntigenFemaleGPI-Linked ProteinsGranulocyte-Macrophage Colony-Stimulating FactorHumansIpilimumabMaleMesothelinMiddle AgedAntibodies, MonoclonalAntineoplastic AgentsCancer VaccinesCTLA-4 AntigenCTLA4 protein, humanGPI-Linked ProteinsGranulocyte-Macrophage Colony-Stimulating FactorIpilimumabMesothelin

Identifiers

PMID23924790
PMCPMC3779664
OpenAlexW2324865626

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.