Evidence map›Paper›PMID 38214716›Full record

ArticleHNO2024

Combination of nivolumab with standard induction chemotherapy in children and adults with EBV-positive nasopharyngeal carcinoma : Protocol of a prospective multicenter phase 2 trial.

Tristan Römer, Christian Vokuhl, Gundula Staatz, Felix M Mottaghy, Hans Christiansen, Michael J Eble, Beate Timmermann, Jens Peter Klussmann, Miriam Elbracht, Gabriele Calaminus and 5 more

Open access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in HNO, 2024. 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
0.8field-weighted citation impact, top 26% 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

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. 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

15 authors at 10 institutions in 1 country.

Tristan RömerDivision of Pediatric Hematology, Oncology and Stem Cell Transplantation, Medical Faculty, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), RWTH Aachen University, Aachen, Germany.
Christian VokuhlSection of Pediatric Pathology, Department of Pathology, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), University Hospital Bonn, Bonn, Germany.
Gundula StaatzSection of Pediatric Radiology, University Medical Center Mainz, Mainz, Germany.
Felix M MottaghyDepartment of Nuclear Medicine, Medical Faculty, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), RWTH Aachen University, Aachen, Germany.
Hans ChristiansenDepartment of Radiotherapy and Radiation Oncology, Hannover Medical School, Hannover, Germany.
Michael J EbleDepartment of Radiation Oncology, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), RWTH Aachen University, Aachen, Germany.
Beate TimmermannDepartment of Particle Therapy, West German Proton Therapy Centre Essen (WPE), West German Cancer Centre (WTZ), University Hospital Essen, Essen, Germany.
Jens Peter KlussmannCenter for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), ENT Clinic of the University Hospital of Cologne, Cologne, Germany.
Miriam ElbrachtInstitute for Human Genetics and Genomic Medicine, Medical Faculty, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), RWTH Aachen University, Aachen, Germany.
Gabriele CalaminusDivision of Pediatric Hematology and Oncology, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), University Hospital Bonn, Bonn, Germany.
Martin ZimmermannDivision of Pediatric Hematology and Oncology, Hannover Medical School, Hannover, Germany.
Tim H BrümmendorfDepartment of Hematology, Oncology, Hemostaseology, Stem Cell Transplantation, Medical Faculty, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), RWTH Aachen University, Aachen, Germany.
Tobias FeuchtingerDivision of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Helena KerpPediatric Research Network gGmbH, University of Duisburg-Essen, Essen, Germany.
Udo KontnyDivision of Pediatric Hematology, Oncology and Stem Cell Transplantation, Medical Faculty, Center for Integrated Oncology Aachen Bonn Cologne Düsseldorf (CIO ABCD), RWTH Aachen University, Aachen, Germany. ukontny@ukaachen.de.
RWTH Aachen University · DEMedizinische Hochschule Hannover · DEDüsseldorf University Hospital · DEHeinrich Heine University Düsseldorf · DEJohannes Gutenberg University Mainz · DEUniversitätsklinikum Aachen · DEUniversity Hospital Bonn · DEUniversity of Duisburg-Essen · DEUniversity of Freiburg · DEWest German Heart and Vascular Center Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment of Epstein-Barr virus(EBV)-positive nasopharyngeal carcinoma (NPC) with cisplatin/5-fluorouracil (5-FU) induction chemotherapy, followed by radiochemotherapy and subsequent interferon‑β, has yielded high survival rates in children, adolescents, and young adults. A previous study has shown that reduction of radiation dose from 59.4 to 54.0 Gy appears to be safe in patients with complete response (CR) to induction chemotherapy. As immune checkpoint-inhibitors have shown activity in NPC, we hypothesize that the addition of nivolumab to standard induction chemotherapy would increase the rate of complete tumor responses, thus allowing for a reduced radiation dose in a greater proportion of patients.

methodsThis is a prospective multicenter phase 2 clinical trial including pediatric and adult patients with their first diagnosis of EBV-positive NPC, scheduled to receive nivolumab in addition to standard induction chemotherapy. In cases of non-response to induction therapy (stable or progressive disease), and in patients with initial distant metastasis, treatment with nivolumab will be continued during radiochemotherapy. Primary endpoint is tumor response on magnetic resonance imaging (MRI) and positron emission tomography (PET) after three cycles of induction chemotherapy. Secondary endpoints are event-free (EFS) and overall survival (OS), safety, and correlation of tumor response with programmed cell death ligand 1 (PD-L1) expression. DISCUSSION: As cure rates in localized EBV-positive NPC today are high with standard multimodal treatment, the focus increasingly shifts toward prevention of late effects, the burden of which is exceptionally high, mainly due to intense radiotherapy. Furthermore, survival in patients with metastatic disease and resistant to conventional chemotherapy remains poor. Primary objective of this study is to investigate whether the addition of nivolumab to standard induction chemotherapy in children and adults with EBV-positive NPC is able to increase the rate of complete responses, thus enabling a reduction in radiation dose in more patients, but also offer patients with high risk of treatment failure the chance to benefit from the addition of nivolumab.

trial registrationEudraCT (European Union Drug Regulating Authorities Clinical Trials Database) No. 2021-006477-32.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsInduction ChemotherapyNasopharyngeal CarcinomaNasopharyngeal NeoplasmsNivolumabAdolescentAdultAgedChemoradiotherapyChildChild, PreschoolClinical Trials, Phase II as TopicEpstein-Barr Virus InfectionsFemaleHumansMaleNivolumabAdolescentsImmune checkpoint-inhibitorInterferonPD-1Radiotherapy

Identifiers

PMID38214716
PMCPMC11116201
OpenAlexW4390795743

What OpenQuestion holds

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LicenceCC BY
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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.