Evidence map›Paper›PMID 40220758›Full record

Trial reportMed (New York, N.Y.)2025

UV1 vaccination in pembrolizumab-treated patients with recurrent or metastatic head and neck cancer: A randomized multicenter phase 2 trial.

Anna Brandt, Konrad Klinghammer, Christoph Schultheiss, Lisa Paschold, Claudia Wickenhauser, Marcus Bauer, Anna Bergqvist, Dennis Hahn, Philippe Schafhausen, Mareike Tometten and 15 more

Abstract readMulticenter StudyClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Med (New York, N.Y.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors.

Anna BrandtDivision of Medical Oncology, University Hospital Basel, Basel, Switzerland.
Konrad KlinghammerDepartment of Hematology and Oncology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Christoph SchultheissDivision of Medical Oncology, University Hospital Basel, Basel, Switzerland; Laboratory of Translational Immuno-Oncology, Department of Biomedicine, University of Basel and University Hospital Basel, Basel, Switzerland.
Lisa PascholdDepartment of Internal Medicine IV, Oncology/Hematology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Claudia WickenhauserInstitute of Pathology, University Hospital Halle, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Marcus BauerInstitute of Pathology, University Hospital Halle, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Anna BergqvistUltimovacs ASA, Oslo, Norway.
Dennis HahnDepartment of Hematology, Oncology, Stem-Cell Transplantation, and Palliative Care Klinikum Stuttgart, Stuttgart, Germany.
Philippe SchafhausenDepartment of Oncology, Hematology, and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Mareike TomettenDepartment of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Markus BlaurockDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medicine Greifswald, Greifswald, Germany.
Henrike Barbara ZechDepartment of Otorhinolaryngology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Chia-Jung BuschDepartment of Otorhinolaryngology, Head and Neck Surgery, University Medicine Greifswald, Greifswald, Germany.
Andreas DietzDepartment of Otolaryngology, Head and Neck Surgery, University of Leipzig, Leipzig, Germany.
Urs Müller-RichterUniversity Hospital Würzburg, Bavarian Cancer Research Center, Würzburg, Germany.
Jürgen AltDepartment of Internal Medicine III (Hematology, Oncology), University Medical Center Mainz, Mainz, Germany.
Andreas BoehmDepartment of Otorhinolaryngology, St. Georg Hospital, Leipzig, Germany.
Simone KowollCoordination Center for Clinical Trials, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Jörg SteighardtCoordination Center for Clinical Trials, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Alexander LaschCoordination Center for Clinical Trials, Medical Faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Ingunn Hagen WestgaardUltimovacs ASA, Oslo, Norway.
Marita WesthrinUltimovacs ASA, Oslo, Norway.
Alexander SteinHematology-Oncology Practice Eppendorf (HOPE), Hamburg, Germany.
Axel HinkeClinical Cancer Research Consulting, Düsseldorf, Germany.
Mascha BinderDivision of Medical Oncology, University Hospital Basel, Basel, Switzerland; Laboratory of Translational Immuno-Oncology, Department of Biomedicine, University of Basel and University Hospital Basel, Basel, Switzerland. Electronic address: mascha.binder@usb.ch.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman telomerase reverse transcriptase is highly expressed in head and neck squamous cell carcinoma (HNSCC). The FOCUS study examines the role of the telomerase-directed vaccine UV1 in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC.

methodsThe FOCUS trial, a two-armed, open-label, randomized, multicenter phase 2 study, was designed to assess the efficacy and feasibility of UV1 as an add-on to pembrolizumab in the first-line treatment of patients with R/M PD-L1

findingsFrom August 2021 to July 2023, 25 patients were enrolled in the pembrolizumab arm and 50 patients in the pembrolizumab + UV1 arm. The PFS rate at 6 months was 40% in the pembrolizumab arm and 30% in the pembrolizumab + UV1 arm. No specific safety signals were observed in the pembrolizumab + UV1 arm apart from a reversible allergic reaction that appeared in one patient. At a median follow-up of 11.3 months, median overall survival was 13.1 months in the pembrolizumab arm and 12.6 months in the pembrolizumab + UV1 arm.

conclusionsThe addition of UV1 to pembrolizumab was safe but did not show an efficacy signal in this study population.

fundingThe legal sponsor of the trial was the University Medical Center Halle (Saale), Germany and was funded by a grant from Ultimovacs.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCancer VaccinesHead and Neck NeoplasmsNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckAdultAgedFemaleHumansMaleMiddle AgedTelomeraseAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCancer VaccinespembrolizumabTelomerasehead and neck cancerhead and neck squamous cell carcinomapembrolizumabTranslation to patientsUV1

Identifiers

PMID40220758

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.