Evidence map›Paper›PMID 40900323›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2025

Translational investigations in the HN1901 phase II window-of-opportunity study investigating the biological activity of an IDO1 (IO102) and PD-L1 (IO103) immune-modulatory peptide cancer vaccines in squamous cell carcinoma of the head and neck.

Simon Beyaert, Axelle Loriot, Michèle Magremanne, William Renwart, Pierre Mahy, Thierry Duprez, Pamela Baldin, Elena Benidovskaya, Nicolas Huyghe, Hajar Dahou and 4 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

14 authors.

Simon BeyaertInstitut de Recherche Expérimentale et Clinique (IREC), pôle MIRO, Université catholique de Louvain (UCLouvain), Brussels, Belgium. simon.beyaert@saintluc.uclouvain.be.ORCID http://orcid.org/0000-0002-7241-526X
Axelle LoriotGroup of Computational Biology and Bioinformatics, de Duve Institute, Université catholique de Louvain, Brussels, Belgium.
Michèle MagremanneDepartment of Oral and Maxillofacial surgery, Institut Roi Albert II & Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
William RenwartDepartment of Head & Neck Surgery, Institut Roi Albert II & Cliniques universitaires Saint-Luc, Brussels, Belgium.
Pierre MahyDepartment of Oral and Maxillofacial surgery, Institut Roi Albert II & Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Thierry DuprezDepartment of Radiology, Institut Roi Albert II & Cliniques universitaires Saint-Luc, Brussels, Belgium.
Pamela BaldinDepartment of Pathology, Cliniques universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Elena BenidovskayaInstitut de Recherche Expérimentale et Clinique (IREC), pôle MIRO, Université catholique de Louvain (UCLouvain), Brussels, Belgium.
Nicolas HuygheInstitut de Recherche Expérimentale et Clinique (IREC), pôle MIRO, Université catholique de Louvain (UCLouvain), Brussels, Belgium.
Hajar DahouInstitut de Recherche Expérimentale et Clinique (IREC), pôle MIRO, Université catholique de Louvain (UCLouvain), Brussels, Belgium.
Vincent Stroobantde Duve Institute, Ludwig Institute for Cancer Research, Brussels, Belgium.
Tiphanie Gomardde Duve Institute, Ludwig Institute for Cancer Research, Brussels, Belgium.
Jean-Pascal MachielsInstitut de Recherche Expérimentale et Clinique (IREC), pôle MIRO, Université catholique de Louvain (UCLouvain), Brussels, Belgium.
Sandra SchmitzInstitut de Recherche Expérimentale et Clinique (IREC), pôle MIRO, Université catholique de Louvain (UCLouvain), Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe HN1901 phase II window-of-opportunity study investigated an IDO1 (IO102) and PD-L1 (IO103) immune-modulatory therapeutic peptide cancer vaccines in monotherapy versus no preoperative treatment in patients with primary squamous cell carcinoma of the head and neck. The primary endpoint was the T-cell peptide specific response measured by INFγ-ELISpot in peripheral blood mononuclear cells. Secondary endpoints included safety, tumor modification assessment and evaluation of T-cell tumoral infiltration. PATIENTS AND

methodsTen patients were randomized between arm A - IO102 and arm B - Control. Five unrandomized additional patients were included in arm C - IO103. Patients received vaccines for three weeks prior to curative treatment. Tumor biopsies, blood samples and radiological imaging were carried out at baseline and before curative treatment.

resultsThe INFγ-ELISpot was positive in one IO103-vaccinated patient. Two IO103-vaccinated patients showed a tumor shrinkage with less cancer-related pain. Vaccine injections were safe and no grade III-IV side effects were attributed to the investigational treatment. For the IO103-vaccinated patient with a positive INFγ-ELISpot, a high baseline expression of PD-L1 and CD274 was demonstrated with high CD8 + T-cell density in his operated tumor. Using spatial transcriptomics in surgical specimens, IO103-vaccinated patients showed high expression of gene lists involved in inflammation compared to controls, particularly in shrunken tumor.

conclusionShort-term treatment with the PD-L1 peptide vaccine IO103 showed tumor size reduction in two patients out of five associated with a positive INFγ-ELISpot and high CD8 + T-cells tumor density in one patient. Spatial transcriptomics analyses showed high expression of inflammation-related gene lists in IO103-vaccinated patients compared to controls. IO102 and IO103 injections were safe during the pre-operative period.

Indexed as

B7-H1 AntigenCancer VaccinesCarcinoma, Squamous CellHead and Neck NeoplasmsIndoleamine-Pyrrole 2,3,-DioxygenaseSquamous Cell Carcinoma of Head and NeckAgedFemaleHumansMaleMiddle AgedVaccines, SubunitB7-H1 AntigenCancer VaccinesCD274 protein, humanIDO1 protein, humanIndoleamine-Pyrrole 2,3,-DioxygenaseVaccines, SubunitHead and neck squamous cell carcinomaIDO1Immune-modulatory therapeutic peptide vaccineMultiplex immunohistochemistryPD-L1Spatial transcriptomicsWindow-study

Identifiers

PMID40900323

What OpenQuestion holds

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Registered trials

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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.