Evidence map›Paper›PMID 40116923›Full record

ArticleCancer immunology, immunotherapy : CII2025

PRGN-2009 and bintrafusp alfa for patients with advanced or metastatic human papillomavirus-associated cancer.

Charalampos S Floudas, Meghali Goswami, Renee N Donahue, Julius Strauss, Danielle M Pastor, Jason M Redman, Isaac Brownell, Evrim B Turkbey, Seth M Steinberg, Lisa M Cordes and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer immunology, immunotherapy : CII, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04432597 (Phase I/II Trial of HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PD-L1/TGF-Beta Trap), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT04432597 phase1 / phase2completednot on this map

Phase I/II Trial of HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PD-L1/TGF-Beta Trap (M7824) in Subjects With HPV Positive Cancers

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2020 to 2026Enrolled39ConditionsHPV Positive Cancer, Vulvar, Vaginal, Penile, Rectal Cancer, Anal Cancer, Oropharyngeal CancerArmsPRGN-2009, M7824, EKG, CT Scan, Brain MRI
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Review
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  10. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  11. 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

21 authors.

Charalampos S FloudasCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA. charalampos.floudas@nih.gov.ORCID http://orcid.org/0000-0002-0020-237X
Meghali GoswamiCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Renee N DonahueCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Julius StraussCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Danielle M PastorCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Jason M RedmanCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Isaac BrownellDermatology Branch, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, MD, USA.
Evrim B TurkbeyRadiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Seth M SteinbergBiostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Lisa M CordesCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Jennifer L MartéCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Maheen H KhanCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Sheri McMahonOffice of Research Nursing, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Elizabeth LampingOffice of Research Nursing, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Michell ManuClinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Manuk ManukyanClinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
Douglas E BroughPrecigen Inc., Germantown, MD, USA.
Amy LankfordPrecigen Inc., Germantown, MD, USA.
Caroline JochemsCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Jeffrey SchlomCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
James L GulleyCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis first-in-human phase 1 study (NCT04432597) evaluated the safety and recommended phase 2 dose (RP2D) of PRGN-2009, a gorilla adenoviral-vector targeting oncoproteins E6, E7 (human papillomavirus (HPV)16/18) and E5 (HPV16), as monotherapy (Arm 1A) and combined with the bifunctional TGF-β "trap"/anti-PD-L1 fusion protein bintrafusp alfa (BA; Arm 1B), in patients with recurrent/metastatic HPV-associated cancer.

methodsPatients with ≥ 1 prior treatment (immunotherapy allowed) received PRGN-2009 (1 × 10

resultsSeventeen patients were treated. In Arm 1A (n = 6) there were no dose limiting toxicities or grade 3/4 treatment-related adverse events (TRAEs), 5 × 10

conclusionsPRGN-2009 was well tolerated, and immune responses were observed to PRGN-2009. Encouraging anti-tumor activity and OS were noted in the combination with BA arm, consisting mainly of checkpoint-resistant patients. Trial Registration ClinicalTrials.gov Identifier: NCT04432597.

Indexed as

NeoplasmsPapillomavirus InfectionsRecombinant Fusion ProteinsAdultAgedFemaleHuman Papillomavirus VirusesHumansMaleMiddle AgedOncogene Proteins, ViralOncogene Proteins, ViralRecombinant Fusion ProteinsCervical cancerGene therapyHPVImmune checkpoint blockadeOropharyngeal cancerTGF-beta inhibition

Identifiers

PMID40116923
PMCPMC11928712

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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.