Evidence map›Paper›PMID 31110074›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2019

A Phase I Dose-Escalation Trial of BN-CV301, a Recombinant Poxviral Vaccine Targeting MUC1 and CEA with Costimulatory Molecules.

Margaret E Gatti-Mays, Julius Strauss, Renee N Donahue, Claudia Palena, Jaydira Del Rivero, Jason M Redman, Ravi A Madan, Jennifer L Marté, Lisa M Cordes, Elizabeth Lamping and 7 more

Open access · greenAbstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 7% 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.

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

42 citing papers in PubMed, 3 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Research progress of MUC1 in genitourinary cancers.Cellular & molecular biology letters · 2024
    Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. CEA vaccines.Human vaccines & immunotherapeutics · 2023
    Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 5 institutions in 2 countries.

Margaret E Gatti-Mays *Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.ORCID https://orcid.org/0000-0001-8914-2897
Julius Strauss *Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Renee N DonahueLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Claudia PalenaLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Jaydira Del RiveroPediatric Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Jason M RedmanMedical Oncology Service, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.ORCID https://orcid.org/0000-0001-8200-0167
Ravi A MadanGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Jennifer L MartéGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Lisa M CordesOncology Clinical Pharmacy, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Elizabeth LampingLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Alanvin OrpiaLeidos Biomedical Research, Inc., Frederick, Maryland.
Andrea BurmeisterLeidos Biomedical Research, Inc., Frederick, Maryland.
Eva WagnerBavarian Nordic GmbH, Martinsried, Germany.
Cesar Pico NavarroBavarian Nordic, Inc., Morrisville, North Carolina.
Christopher R HeeryBavarian Nordic, Inc., Morrisville, North Carolina.
Jeffrey Schlom *Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.ORCID https://orcid.org/0000-0001-7932-4072
James L Gulley *Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland. gulleyj@mail.nih.gov.
National Cancer Institute · USNational Institutes of Health · USBavarian Nordic (United States) · USLeidos (United States) · USBavarian Nordic (Germany) · DE

Funding

Cancer Immunotherapy Clinical TrialsZIABC011547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI STRAUSS, JULIUS · 2014 to 2023
$8.1M
Vaccine Clinical TrialsZ01BC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2005 to 2008
$1.7M
Intramural NIH HHS Z01 BC010666
6 · The paper itself

Abstract

purposeBN-CV301 is a poxviral-based vaccine comprised of recombinant (rec.) modified vaccinia Ankara (MVA-BN-CV301; prime) and rec. fowlpox (FPV-CV301; boost). Like its predecessor PANVAC, BN-CV301 contains transgenes encoding tumor-associated antigens MUC1 and CEA as well as costimulatory molecules (B7.1, ICAM-1, and LFA-3). PANVAC was reengineered to make it safer and more antigenic. PATIENTS AND

methodsThis open-label, 3+3 design, dose-escalation trial evaluated three dose levels (DL) of MVA-BN-CV301: one, two, or four subcutaneous injections of 4 × 10

resultsThere were no dose-limiting toxicities. Twelve patients enrolled on trial [dose level (DL) 1 = 3, DL2 = 3, DL3 = 6). Most side effects were seen with the prime doses and lessened with subsequent boosters. All treatment-related adverse events were temporary, self-limiting, grade 1/2, and included injection-site reactions and flu-like symptoms. Antigen-specific T cells to MUC1 and CEA, as well as to a cascade antigen, brachyury, were generated in most patients. Single-agent BN-CV301 produced a confirmed partial response (PR) in 1 patient and prolonged stable disease (SD) in multiple patients, most notably in

conclusionsThe BN-CV301 vaccine can be safely administered to patients with advanced cancer. Further studies of the vaccine in combination with other agents are planned.

Indexed as

Cancer VaccinesCarcinoembryonic AntigenAnimalsCD58 AntigensHumansIntercellular Adhesion Molecule-1Mucin-1T-LymphocytesVaccinia virusCancer VaccinesCarcinoembryonic AntigenCD58 AntigensIntercellular Adhesion Molecule-1MUC1 protein, humanMucin-1

Identifiers

PMID31110074
PMCPMC6697621
OpenAlexW2946549590

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.