Evidence map›Paper›PMID 40781051›Full record

Trial reportUrologic oncology2025

Bacillus Calmette-Guérin (BCG) in combination with PANVAC™ vs. BCG alone in adults with high-grade BCG-refractory non-muscle-invasive bladder cancer.

Matthew Ho, Alon Lazarovich, Ragheed Saoud, Aaron Dahmen, Samuel Tremblay, Siobhan Telfer, Mahir Maruf, Eric A Singer, Robert E Weiss, Thomas L Jang and 15 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Urologic oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Round up.Indian journal of urology : IJU : journal of the Urological Society of India
    Article
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

25 authors.

Matthew HoDepartment of Surgery, Section of Urology, The University of Chicago, Chicago, IL.
Alon LazarovichDepartment of Surgery, Section of Urology, The University of Chicago, Chicago, IL.
Ragheed SaoudArthur Smith Institute of Urology, Northwell Health, New Hyde Park, NY.
Aaron DahmenDepartment of Surgery, Section of Urology, The University of Chicago, Chicago, IL.
Samuel TremblayDepartment of Surgery, Section of Urology, The University of Chicago, Chicago, IL.
Siobhan TelferUniversity of Pittsburgh Medical Center, Pittsburgh, PA.
Mahir MarufDepartment of Urology, University of Michigan, Ann Arbor, MI.
Eric A SingerThe Ohio State University Comprehensive Cancer Center, Columbus, OH.
Robert E WeissRutgers Cancer Institute of New Jersey and Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
Thomas L JangRutgers Cancer Institute of New Jersey and Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
Sammy E ElsamraRutgers Cancer Institute of New Jersey and Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
Maria MerinoCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Rebecca DolanFrederick National Laboratory for Cancer Research.
Vladimir ValeraCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Beatriz Walter RodriquezCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Reema RailkarCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Sonia BellfieldCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Lambros StamatakisMedstar Georgetown University Hospital, Washington, DC.
Joanna ShihCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Renee N DonahueCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Cesar Pico NavarroBavarian Nordic, Morrisville, NC.
Andrea B ApoloCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
James L GulleyCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Jeffrey SchlomCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD.
Piyush K AgarwalDepartment of Surgery, Section of Urology, The University of Chicago, Chicago, IL. Electronic address: pkagarwal@bsd.uchicago.edu.

Funding

Intramural NIH HHS Z99 CA999999
6 · The paper itself

Abstract

purposeWe postulated that PANVAC™, a recombinant poxviral vector vaccine, could enhance the immunologic and clinical response to an additional induction course of bacillus Calmette-Guérin (BCG) in patients with recurrent high-grade non-muscle-invasive bladder cancer (NMIBC).

methodsThis was a randomized, open-label, prospective, phase II study in subjects with high-grade NMIBC who had failed at least 1 induction course of intravesical BCG. Patients were randomized to either BCG alone or BCG+PANVAC. All subjects received intravesical BCG for 6 weeks. Patients in the combination arm also received priming and booster doses of PANVAC. The primary endpoint was recurrence-free survival. Secondary endpoints included progression-free survival and radical cystectomy-free survival. We also evaluated exploratory secondary immunological response endpoints.

resultsOur study concluded based on preplanned futility analysis. Overall, 32 patients were enrolled; 2 withdrew. Thirty patients (15/arm) were analyzed; 5 (33.3%) in the BCG-alone arm and 5 (33.3%) in the BCG+PANVAC arm met criteria for BCG- unresponsive disease. 12-month recurrence-free survival was 53.3% for the BCG-alone arm and 40% for the BCG+PANVAC arm. Overall recurrence rate at any time point was 73.3% at a median of 10.8 months, for an overall recurrence rate of 66.7% in the BCG-alone arm and 80% in the BCG+PANVAC arm. There was no difference in median recurrence-free survival or progression-free survival.

conclusionsThis phase II study demonstrated no improvement in recurrence-free survival with BCG+PANVAC compared to BCG alone in patients with NMIBC who failed to respond to intravesical BCG.

Indexed as

BCG VaccineUrinary Bladder NeoplasmsAdjuvants, ImmunologicAdultAgedFemaleHumansMaleMiddle AgedNeoplasm InvasivenessNeoplasm Recurrence, LocalNon-Muscle Invasive Bladder NeoplasmsProspective StudiesAdjuvants, ImmunologicBCG VaccineBCGNon-muscle invasive bladder cancerPANVAC™

Identifiers

PMID40781051
PMCPMC12547981

What OpenQuestion holds

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Registered trials

None linked

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.