Evidence map›Paper›PMID 20842054›Full record

Trial reportJournal of immunotherapy (Hagerstown, Md. : 1997)2010

Phase 2 trial of single agent Ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma.

Richard E Royal, Catherine Levy, Keli Turner, Aarti Mathur, Marybeth Hughes, Udai S Kammula, Richard M Sherry, Suzanne L Topalian, James C Yang, Israel Lowy and 1 more

4 registry-linked trialsAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of immunotherapy (Hagerstown, Md. : 1997), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 805 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
805citing papers in PubMed, 5 pooled it
–field-weighted citation impact
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.

NCT00112580 phase2completednot on this map

Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

TypeinterventionalSponsorBristol-Myers SquibbRan2005 to 2009Enrolled27ConditionsPancreatic CancerArmsipilimumab
NCT02704156 phase2completednot on this mapstarted 2016, after this paper: background citation

Stereotactic Body Radiation Therapy Plus Pembrolizumab and Trametinib vs. Stereotactic Body Radiation Therapy Plus Gemcitabine for Locally Recurrent Pancreatic Cancer After Surgical Resection: an Open-label, Randomized, Controlled, Phase 2 Trial

TypeinterventionalSponsorChanghai HospitalRan2016 to 2020Enrolled170ConditionsPancreatic CancerArmsCyberknife plus Pembrolizumab and Trametinib, Cyberknife plus Gemcitabine
NCT04787991 phase1completednot on this mapstarted 2021, after this paper: background citation

A Multicenter, Open-label, ExploRatory Platform Trial to EValuate ImmunOtherapy Combinations With Chemotherapy for the Treatment of Patients With PreviousLy UnTreated MetastatIc Pancreatic AdenOcarciNoma (REVOLUTION)

TypeinterventionalSponsorCancer Insight, LLCRan2021 to 2025Enrolled45ConditionsMetastatic Pancreatic AdenocarcinomaArmsNivolumab (Cohort A), Ipilimumab (Cohort A, B and C), Hydroxychloroquine (HCQ) (Cohort B), Nab-paclitaxel (nP) (Cohort A, B and C), Gemcitabine (gem) (Cohort A, B and C)
NCT07595172 phase1 / phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Phase I/II Clinical Trial of NALIRIFOX Combined With Adebrelimab and PULSAR as First-Line Treatment for Locally Advanced Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma

TypeinterventionalSponsorWest China HospitalRan2026 to 2029Enrolled55ConditionsPancreatic Ductal Adenocarcinoma (PDAC), Locally Advanced and Metastatic Pancreatic CancerArmsNALIRIFOX+Adebrelimab, PULSAR
3 · Its place in the literature

Who cites it

805 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
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  10. Dendritic Cell-Based Immunotherapy in Patients With Resected Pancreatic Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  11. Trial
  12. Omega-3 fatty acids reprogram tumor-associated macrophage cytokine signaling and suppress pancreatic cancer growth.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review

745 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Richard E RoyalSurgery Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. rroyal@mdanderson.org
Catherine Levy
Keli Turner
Aarti Mathur
Marybeth Hughes
Udai S Kammula
Richard M Sherry
Suzanne L Topalian
James C Yang
Israel Lowy
Steven A Rosenberg

Funding

Adoptive Cell Transfer Immunotherapy of CancerZIABC010984 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2025
$56.8M
Gene therapy of cancerZ01BC010985 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2008 to 2008
$1.5M
Intramural NIH HHS Z01 BC010985
6 · The paper itself

Abstract

New, effective therapies are needed for pancreatic ductal adenocarcinoma. Ipilimumab can mediate an immunologic tumor regression in other histologies. This phase II trial evaluated the efficacy of Ipilimumab for advanced pancreatic cancer. Subjects were adults with locally advanced or metastatic pancreas adenocarcinoma with measurable disease, good performance status, and minimal comorbidities. Ipilimumab was administered intravenously (3.0 mg/kg every 3 wk; 4 doses/course) for a maximum of 2 courses. Response rate by response evaluation criteria in solid tumors criteria and toxicity were measured. Twenty-seven subjects were enrolled (metastatic disease: 20 and locally advanced: 7) with median age of 55 years (27 to 68 y) and good performance status (26 with Eastern Cooperative Oncology Group performance status =0 to 1). Three subjects experienced ≥ grade 3 immune-mediated adverse events (colitis:1, encephalitis:1, hypohysitis:1). There were no responders by response evaluation criteria in solid tumors criteria but a subject experienced a delayed response after initial progressive disease. In this subject, new metastases after 2 doses of Ipilimumab established progressive disease. But continued administration of the agent per protocol resulted in significant delayed regression of the primary lesion and 20 hepatic metastases. This was reflected in tumor markers normalization, and clinically significant improvement of performance status. Single agent Ipilimumab at 3.0 mg/kg/dose is ineffective for the treatment of advanced pancreas cancer. However, a significant delayed response in one subject of this trial suggests that immunotherapeutic approaches to pancreas cancer deserve further exploration.

Indexed as

ImmunotherapyAdenocarcinomaAdultAgedAntibodies, MonoclonalAntigens, CDColitisCTLA-4 AntigenDisease ProgressionFemaleHumansInjections, IntravenousIpilimumabMaleMiddle AgedNeoplasm MetastasisAntibodies, MonoclonalAntigens, CDCTLA-4 AntigenCTLA4 protein, humanIpilimumab

Identifiers

PMID20842054
PMCPMC7322622

What OpenQuestion holds

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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.