Evidence map›Paper›PMID 35277461›Full record

Trial reportJournal for immunotherapy of cancer2022

Phase 2 trial of T-cell activation using MVI-816 and pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC).

Douglas G McNeel, Jens C Eickhoff, Ellen Wargowski, Laura E Johnson, Christos E Kyriakopoulos, Hamid Emamekhoo, Joshua M Lang, Mary Jane Brennan, Glenn Liu

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02499835 (Pilot Trial of pTVG-HP DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
6.8field-weighted citation impact, top 2% 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.

NCT02499835 phase1 / phase2completednot on this map

Pilot Trial of pTVG-HP DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer

TypeinterventionalSponsorUniversity of Wisconsin, MadisonRan2015 to 2023Enrolled66ConditionsHormone-Resistant Prostate Cancer, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Soft Tissues, Metastatic Prostate CarcinomaArmsPembrolizumab, pTVG-HP Plasmid DNA Vaccine
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 50 citations in OpenAlex.

  1. Trial
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  5. Article
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  13. DNA-based immunotherapy for cancer: In vivo approaches for recalcitrant targets.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  14. Bolstering CD8Biology · 2025
    Review
  15. Article
  16. Review
  17. Review
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  20. 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

9 authors at 1 institution in 1 country.

Douglas G McNeelDepartment of Medicine, Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA dm3@medicine.wisc.edu.ORCID 0000-0003-1471-6723
Jens C EickhoffDepartment of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Ellen WargowskiDepartment of Medicine, Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Laura E JohnsonDepartment of Medicine, Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Christos E KyriakopoulosDepartment of Medicine, Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.ORCID 0000-0002-6452-7405
Hamid EmamekhooDepartment of Medicine, Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Joshua M LangDepartment of Medicine, Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Mary Jane BrennanDepartment of Medicine, Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Glenn LiuDepartment of Medicine, Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin, USA.
University of Wisconsin–Madison · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Justine Yang Bruce · 1985 to 2026
$142.6M
Effective Anti-Tumor Vaccination - Targeting Checkpoint Regulation at the Time of T-cell ActivationR01CA219154 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI MCNEEL, DOUGLAS G. · 2017 to 2021
$1.7M
NCI NIH HHS P30 CA014520NCI NIH HHS R01 CA219154
6 · The paper itself

Abstract

backgroundWe previously reported a trial using a DNA vaccine encoding prostatic acid phosphatase (MVI-816, pTVG-HP), given over 12 weeks concurrently or sequentially with pembrolizumab, in patients with mCRPC. We report the final analysis of this trial following two additional treatment arms in which patients with mCRPC continued concurrent treatment until progression. MATERIALS AND

methodsPatients with mCRPC were treated with MVI-816 and pembrolizumab every 3 weeks (arm 3, n=20) or MVI-816 every 2 weeks and pembrolizumab every 4 weeks (arm 4, n=20). The primary objectives were safety, 6-month progression-free survival (PFS), median time to radiographic progression, and objective response rates. Secondary objectives included immunological evaluations.

resultsIn 25 patients with measurable disease, there were no complete response and one confirmed partial response in a patient who subsequently found to have an MSI

conclusionsFindings here demonstrate that combining programmed cell death 1 blockade with MVI-816 is safe, can augment tumor-specific T cells, and can result in a favorable 6-month disease control rate. Correlative studies suggest T-cell activation by vaccination is critical to the mechanism of action of this combination. Future randomized clinical trials are needed to validate these findings. TRIAL REGISTRATION NUMBER: NCT02499835.

Indexed as

Prostatic Neoplasms, Castration-ResistantVaccines, DNAAntibodies, Monoclonal, HumanizedHumansMaleProgression-Free SurvivalAntibodies, Monoclonal, HumanizedpembrolizumabVaccines, DNAclinical trials, phase II as topiccostimulatory and inhibitory T-cell receptorsimmunogenicity, vaccineprostatic neoplasms

Identifiers

PMID35277461
PMCPMC8919462
OpenAlexW4221045886

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.