Evidence map›Paper›PMID 40550568›Full record

Trial reportJournal for immunotherapy of cancer2025

Programmed death-1 inhibition increases vaccine-induced T-cell infiltration in patients with prostate cancer.

Wiem Lassoued, Ravi A Madan, Elisabetta Xue, Daniel Burnett, Kenneth D Canubas, Shania Bailey, Jennifer L Marté, Yo-Ting Tsai, Renee N Donahue, Ismail Baris Turkbey and 13 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02933255 (Phase I/II Study of PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

NCT02933255 phase1 / phase2completednot on this map

Phase I/II Study of PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2017 to 2023Enrolled24ConditionsProstate CancerArmsPROSTVAC-V/F, Nivolumab, Prostatectomy, Biopsy, Tylenol
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Cancer vaccines: advances, hurdles, and future directions.Exploration of targeted anti-tumor therapy · 2025
    Review
  6. Review
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

23 authors.

Wiem LassouedCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0009-0004-5742-6982
Ravi A MadanGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0001-5106-8636
Elisabetta XueCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Daniel BurnettCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0009-0004-9063-1806
Kenneth D CanubasCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Shania BaileyCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Jennifer L MartéCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Yo-Ting TsaiCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0002-7556-1633
Renee N DonahueCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0002-6828-3073
Ismail Baris TurkbeyMolecular Imaging Program, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Antonios Papanicolau-SengoSpecial volunteer at the Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Moniquea WilliamsGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Amy HankinGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Manuk ManukyanClinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Michell ManuClinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Zhigang KangOMICS Technology Facility, Genetics Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Colin PritchardDepartment of Laboratory Medicine and Pathology and Brotman Baty Institute for Precision Medicine, University of Washington, Seattle, Washington, USA.
William DahutGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Fatima KarzaiGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0002-3244-1332
Jeffrey SchlomCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID http://orcid.org/0000-0001-7932-4072
Sam SaterCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Peter PintoUrologic Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
James L GulleyCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA gulleyj@mail.nih.gov.ORCID http://orcid.org/0000-0002-6569-2912

Funding

TRANSCRIPTOME AND PROTEOME STRATIFICATION OF PROSTATE ADENOCARCINOMA PHENOTYPESP50CA097186 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI PETER S NELSON · 2002 to 2026
$58.1M
NCI NIH HHS P50 CA097186
6 · The paper itself

Abstract

backgroundProstate cancer (PC) is the most frequently diagnosed cancer in men worldwide, making up 21% of all cancer cases. Although generally slow-growing, 370,000 men die from PC yearly. Immune checkpoint inhibitors (ICIs) are currently only indicated for the rare cases of microsatellite instability high or tumor mutation burden high disease. Combination therapy strategies that induce immune responses may expand the utility of ICIs. Here, we investigated the safety and efficacy of PROSTVAC, a therapeutic cancer vaccine that targets prostate-specific antigen (PSA), in combination with the programmed cell death protein-1 inhibitor nivolumab (NCT02933255).

methodsWe enrolled two cohorts in this trial (phase 1 and 2), both treated with PROSTVAC vaccine and nivolumab. The lead-in cohort had 12 patients with metastatic castration-resistant PC (mCRPC); the neoadjuvant cohort included 12 patients with localized PC who were candidates for radical prostatectomy (RP). We assessed tumor-infiltrating lymphocytes and programmed death-ligand 1 expression in matched formalin-fixed paraffin-embedded samples from baseline biopsies and RP samples. We measured changes in peripheral blood serum analytes, immune cell subsets and antigen-specific T cells targeting PSA, brachyury, and MUC-1 in both cohorts.

resultsIn the lead-in cohort, two patients had a prolonged complete radiographic response by Response Evaluation Criteria in Solid Tumors V.1.1. In the neoadjuvant cohort, CD4

conclusionNeoadjuvant PROSTVAC in combination with nivolumab is associated with increased intratumoral T-cell infiltrates, increased circulating tumor-associated antigen-specific T cells, and with radiographic and biochemical responses in the mCRPC setting. Our findings support the idea that the addition of a vaccine to a tumor-associated antigen might improve the clinical activity of immune checkpoint inhibition. TRIAL REGISTRATION NUMBER: NCT02933255.

Indexed as

Cancer VaccinesImmune Checkpoint InhibitorsLymphocytes, Tumor-InfiltratingNivolumabProgrammed Cell Death 1 ReceptorProstatic NeoplasmsAgedHumansMaleMiddle AgedCancer VaccinesImmune Checkpoint InhibitorsNivolumabPDCD1 protein, humanProgrammed Cell Death 1 ReceptorPROSTVACCombination therapyProstate CancerTumor infiltrating lymphocyte - TIL

Identifiers

PMID40550568
PMCPMC12184344

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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.