Evidence map›Paper›PMID 31422216›Full record

Trial reportOral oncology2019

Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age.

Nabil F Saba, George Blumenschein, Joel Guigay, Lisa Licitra, Jerome Fayette, Kevin J Harrington, Naomi Kiyota, Maura L Gillison, Robert L Ferris, Vijayvel Jayaprakash and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Oral oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02105636 (An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck), which is not on this map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 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.

NCT02105636 phase3completednot on this map

An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

TypeinterventionalSponsorBristol-Myers SquibbRan2014 to 2021Enrolled361ConditionsSquamous Cell Carcinoma of the Head and NeckArmsNivolumab, Cetuximab, Methotrexate, Docetaxel
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. 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
  8. Effect of performance status on the therapeutic effect of nivolumab in recurrent or metastatic squamous cell carcinoma of the head and neck.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
    Article
  9. Article
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  13. Immunotherapy: The Fourth Domain in Oral Cancer Therapeutics.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2024
    Article
  14. Research progress of immunotherapy for advanced head and neck cancer.Medical oncology (Northwood, London, England) · 2024
    Review
  15. Article
  16. Article
  17. Review
  18. Article
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  20. 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

12 authors.

Nabil F SabaWinship Cancer Institute of Emory University, 1365-C Clifton Road NE, Atlanta, GA 30322, USA. Electronic address: nfsaba@emory.edu.
George BlumenscheinMD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. Electronic address: gblumens@mdanderson.org.
Joel GuigayCentre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, 33 Avenue de Valombrose, Nice 06189, France. Electronic address: joel.guigay@nice.unicancer.fr.
Lisa LicitraFondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, via Venezian 1, Milan 20133, Italy. Electronic address: lisa.licitra@istitutotumori.mi.it.
Jerome FayetteCentre Leon Berard, 28 Prom. Léa et Napoléon Bullukian, Lyon 69008, France. Electronic address: jerome.fayette@lyon.unicancer.fr.
Kevin J HarringtonRoyal Marsden NHS Foundation Trust/The Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK. Electronic address: kevin.harrington@icr.ac.uk.
Naomi KiyotaKobe University Hospital Cancer Center, 7 Chome-5-2 Kusunokicho, Chuo Ward, Kobe 650-0017, Japan. Electronic address: nkiyota@med.kobe-u.ac.jp.
Maura L GillisonMD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. Electronic address: mgillison@mdanderson.org.
Robert L FerrisUniversity of Pittsburgh Medical Center Hillman Cancer Center, 5115 Centre Ave., Pittsburgh, PA 15232, USA. Electronic address: ferrisrl@upmc.edu.
Vijayvel JayaprakashBristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville 08648, NJ, USA. Electronic address: Vijayvel.Jayaprakash@bms.com.
Li LiBristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville 08648, NJ, USA. Electronic address: Li.Li6@bms.com.
Peter BrossartUniversity Hospital of Bonn, Sigmund-Freud-Straße 25, Bonn 53127, Germany. Electronic address: Peter.Brossart@ukbonn.de.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
WILD TYPE P53-BASED ADJUVANT IMMUNOTHERAPY FOR SCCHNP50CA097190 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Greg M. Delgoffe · 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

objectivesMany patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. PATIENTS AND

methodsEligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months).

resultsAt baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (<65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population.

conclusionIn CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: NCT02105636.

Indexed as

AgedAge FactorsAntineoplastic Agents, ImmunologicalFemaleHumansMaleNeoplasm MetastasisNivolumabSquamous Cell Carcinoma of Head and NeckAntineoplastic Agents, ImmunologicalNivolumabAgeBiomarkersNivolumabPhase 3 clinical trialSquamous cell carcinoma of the head and neck

Identifiers

PMID31422216
PMCPMC7723820

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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.