Evidence map›Paper›PMID 31239321›Full record

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

Nivolumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: Efficacy and Safety in CheckMate 141 by Prior Cetuximab Use.

Robert L Ferris, Lisa Licitra, Jerome Fayette, Caroline Even, George Blumenschein, Kevin J Harrington, Joel Guigay, Everett E Vokes, Nabil F Saba, Robert Haddad and 9 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report 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 94 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 1 pooled it
–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

94 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. "Histologic type, treatment and prognosis of carcinomas of the larynx: A review".Virchows Archiv : an international journal of pathology · 2026
    Review
  7. Review
  8. Article
  9. Review
  10. Immune biomarkers for head and neck cancer.Cancer immunology, immunotherapy : CII · 2025
    Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Salivary biomarkers: a promising approach for predicting immunotherapy response in head and neck cancers.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  16. Review
  17. Article
  18. Microenvironment-based immunotherapy in oral cancer: a comprehensive review.Medical oncology (Northwood, London, England) · 2025
    Review
  19. Article
  20. Review

34 more citing papers are in PubMed but not listed here.

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

19 authors.

Robert L FerrisDepartments of Otolaryngology and Immunology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania. ferrisrl@upmc.edu.
Lisa LicitraHead and Neck Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy.
Jerome FayetteMedical Oncology, Centre Leon Berard, Lyon, France.
Caroline EvenMedical Oncology, Gustave Roussy, Villejuif Cedex, France.
George BlumenscheinDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Kevin J HarringtonRadiotherapy and Imaging, Royal Marsden/The Institute of Cancer Research, National Institute of Health Research Biomedical Research Center, London, United Kingdom.
Joel GuigayMedical Oncology, Centre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France.
Everett E VokesMedical Oncology, University of Chicago Medical Center, Chicago, Illinois.
Nabil F SabaDepartment of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia.
Robert HaddadDepartment of Medical Oncology, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.
Shanmugasundaram RamkumarClinical Oncology, University Hospital Southampton/NHS Foundation Trust, Southampton, United Kingdom.
Jeffery RussellHead and Neck/Cutaneous/Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0003-2018-7573
Peter BrossartDepartment of Oncology, Hematology, Immuno-oncology and Rheumatology, University Hospital of Bonn, Bonn, Germany.
Makoto TaharaDivision of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0001-9035-3106
A Dimitrios ColevasDepartment of Medicine, Stanford University, Stanford, California.
Fernando Concha-BenaventeDepartments of Otolaryngology and Immunology, University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, Pennsylvania.
Mark LynchGlobal Clinical Development, Bristol-Myers Squibb, Princeton, New Jersey.
Li LiGlobal Biometrics Sciences, Bristol-Myers Squibb, Princeton, New Jersey.
Maura L GillisonDepartment of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
WILD TYPE P53-BASED ADJUVANT IMMUNOTHERAPY FOR SCCHNP50CA097190 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI CHRISTOPHER J. BAKKENIST · 2004 to 2026
$49.6M
Mechanisms of PD-1 and Tim-3 crosstalk in tumor-infiltrating lymphocytesR01CA206517 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Robert L. Ferris, Lawrence P. Kane · 2016 to 2026
$4.6M
NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA047904NCI NIH HHS P50 CA097190NCI NIH HHS R01 CA206517
6 · The paper itself

Abstract

purposeCetuximab, which modulates immune responses, may affect the efficacy of subsequent immunotherapy. Here, we assessed outcomes with nivolumab, by prior cetuximab exposure, in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) who had experienced progression within 6 months of platinum-containing chemotherapy. PATIENTS AND

methodsIn the randomized, open-label, phase III CheckMate 141 trial, patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC) of single-agent chemotherapy, with stratification by prior cetuximab exposure. The primary endpoint was overall survival (OS); additional endpoints were progression-free survival, objective response rate, and safety.

resultsIn patients with prior cetuximab exposure, the median OS was 7.1 months with nivolumab versus 5.1 months with IC (HR, 0.84; 95% CI, 0.62-1.15); OS benefit with nivolumab was maintained across most demographic subgroups. In patients without prior cetuximab exposure, the median OS was 8.2 months with nivolumab versus 4.9 months with IC (HR, 0.52; 95% CI, 0.35-0.77); OS benefit with nivolumab was maintained across patient baseline subgroups including tumor programmed death ligand 1 (PD-L1) expression (<1% or ≥1%). Grade 3-4 treatment-related adverse event rates favored nivolumab versus IC in both subgroups.

conclusionsNivolumab appeared to improve efficacy versus IC regardless of prior cetuximab use, supporting its use in patients with R/M SCCHN with or without prior cetuximab exposure. The reduction in risk of death with nivolumab compared with IC was greater in patients without prior cetuximab exposure versus with prior cetuximab exposure.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalCetuximabErbB ReceptorsHead and Neck NeoplasmsHumansImmunotherapyMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalNivolumabProgrammed Cell Death 1 ReceptorSquamous Cell Carcinoma of Head and NeckSurvival RateAntineoplastic Agents, ImmunologicalCetuximabEGFR protein, humanErbB ReceptorsNivolumabPDCD1 protein, humanProgrammed Cell Death 1 Receptor

Identifiers

PMID31239321
PMCPMC7721346

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.