Evidence map›Paper›PMID 24514956›Full record

Trial reportCancer immunology, immunotherapy : CII2014

A combination trial of vaccine plus ipilimumab in metastatic castration-resistant prostate cancer patients: immune correlates.

Caroline Jochems, Jo A Tucker, Kwong-Yok Tsang, Ravi A Madan, William L Dahut, David J Liewehr, Seth M Steinberg, James L Gulley, Jeffrey Schlom

Abstract readClinical Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 2 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Review
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  9. Emerging Biomarker-Guided Therapies in Prostate Cancer.Current oncology (Toronto, Ont.) · 2022
    Review
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  11. Article
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  14. Article
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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

9 authors.

Caroline JochemsLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, 10 Center Drive, Room 8B09, Bethesda, MD, 20892, USA.
Jo A Tucker
Kwong-Yok Tsang
Ravi A Madan
William L Dahut
David J Liewehr
Seth M Steinberg
James L Gulley
Jeffrey Schlom

Funding

Human T Cell Responses to Tumor Antigens for Cancer Vaccine DevelopmentZIABC010598 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2025
$19.3M
Clinical trials employing cancer vaccine combination therapiesZIABC010945 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2022
$9.6M
Analyses of human T regulatory cellsZIABC010973 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI TSANG, KWONG YOK · 2009 to 2016
$3.7M
Intramural NIH HHS ZIA BC010598
6 · The paper itself

Abstract

We recently reported the clinical results of a Phase I trial combining ipilimumab with a vaccine containing transgenes for prostate-specific antigen (PSA) and for a triad of costimulatory molecules (PROSTVAC) in patients with metastatic castration-resistant prostate cancer. Thirty patients were treated with escalating ipilimumab and a fixed dose of vaccine. Of 24 chemotherapy-naïve patients, 58 % had a PSA decline. Combination therapy did not exacerbate the immune-related adverse events associated with ipilimumab. Here, we present updated survival data and an evaluation of 36 immune cell subsets pre- and post-therapy. Peripheral blood mononuclear cells were collected before therapy, at 13 days and at 70 days post-initiation of therapy, and phenotyped by flow cytometry for the subsets of T cells, regulatory T cells, natural killer cells, and myeloid-derived suppressor cells. Associations between overall survival (OS) and immune cell subsets prior to treatment, and the change in a given immune cell subset 70 days post-initiation of therapy, were evaluated. The median OS was 2.63 years (1.77-3.45). There were trends toward associations for longer OS and certain immune cell subsets before immunotherapy: lower PD-1(+)Tim-3(NEG)CD4EM (P = 0.005, adjusted P = 0.010), higher PD-1(NEG)Tim-3(+)CD8 (P = 0.002, adjusted P = 0.004), and a higher number of CTLA-4(NEG) Tregs (P = 0.005, adjusted P = 0.010). We also found that an increase in Tim-3(+) natural killer cells post- versus pre-vaccination associated with longer OS (P = 0.0074, adjusted P = 0.015). These results should be considered as hypothesis generating and should be further evaluated in larger immunotherapy trials.

Indexed as

AdenocarcinomaAntibodies, MonoclonalAntigens, DifferentiationCancer VaccinesCombined Modality TherapyFlow CytometryHepatitis A Virus Cellular Receptor 2HumansImmunophenotypingIpilimumabKaplan-Meier EstimateKiller Cells, NaturalLymphocyte CountMaleMembrane ProteinsProstate-Specific AntigenAntibodies, MonoclonalAntigens, DifferentiationCancer VaccinesHAVCR2 protein, humanHepatitis A Virus Cellular Receptor 2IpilimumabMembrane ProteinsProstate-Specific AntigenPROSTVACVaccines, Synthetic

Identifiers

PMID24514956
PMCPMC6314199

What OpenQuestion holds

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Registered trials

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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.