Evidence map›Paper›PMID 29884413›Full record

Trial reportOral oncology2018

Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.

Robert L Ferris, George Blumenschein, Jerome Fayette, Joel Guigay, A Dimitrios Colevas, Lisa Licitra, Kevin J Harrington, Stefan Kasper, Everett E Vokes, Caroline Even and 11 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oral oncology, 2018. 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 432 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
432citing papers in PubMed, 12 pooled it
36.3field-weighted citation impact, top 1% 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.

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

432 citing papers in PubMed, 12 syntheses or guidelines pooled it, 786 citations in OpenAlex.

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  4. Progress in immunotherapy for resectable head and neck squamous cell carcinoma.Medical oncology (Northwood, London, England) · 2025
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  15. Long-term Survival and Molecular Biomarker Evaluation of a Phase II Cetuximab and Nivolumab Clinical Trial in Recurrent/Metastatic Head and Neck Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
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  17. Duvelisib with Docetaxel for Patients with Anti-PD-1 Refractory, Recurrent, or Metastatic Head and Neck Squamous Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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372 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

21 authors at 18 institutions in 8 countries.

Robert L FerrisUniversity of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA. Electronic address: ferrisrl@upmc.edu.
George BlumenscheinMD Anderson Cancer Center, Houston, TX, USA.
Jerome FayetteCentre Leon Berard, Lyon, France.
Joel GuigayCentre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France.
A Dimitrios ColevasStanford University, Stanford, CA, USA.
Lisa LicitraFondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, Milan, Italy.
Kevin J HarringtonRoyal Marsden NHS Foundation Trust/The Institute of Cancer Research National Institute of Health Research Biomedical Research Centre, London, UK.
Stefan KasperWest German Cancer Center, University Hospital, Essen, Germany.
Everett E VokesUniversity of Chicago Medical Center, Chicago, IL, USA.
Caroline EvenGustave Roussy, Villejuif Cedex, France.
Francis WordenUniversity of Michigan, Ann Arbor, MI, USA.
Nabil F SabaWinship Cancer Institute of Emory University, Atlanta, GA, USA.
Lara Carmen Iglesias DocampoHospital Universitario 12 de Octubre, Madrid, Spain.
Robert HaddadDana-Farber/Harvard Cancer Center, Boston, MA, USA.
Tamara RordorfUniversitätsspital Zurich, Zurich, Switzerland.
Naomi KiyotaKobe University Hospital, Kobe, Japan.
Makoto TaharaNational Cancer Center Hospital East, Kashiwa, Japan.
Mark LynchBristol-Myers Squibb, Princeton, NJ, USA.
Vijayvel JayaprakashBristol-Myers Squibb, Princeton, NJ, USA.
Li LiBristol-Myers Squibb, Princeton, NJ, USA.
Maura L GillisonMD Anderson Cancer Center, Houston, TX, USA.
Bristol-Myers Squibb (United States) · USThe University of Texas MD Anderson Cancer Center · USCentre Antoine Lacassagne · FRCentre Léon Bérard · FRDana-Farber/Harvard Cancer Center · USEmory University · USFondazione IRCCS Istituto Nazionale dei Tumori · ITHospital Universitario 12 De Octubre · ESInstitut Gustave Roussy · FRKobe University Hospital · JPNational Cancer Center Hospital East · JPRoyal Marsden NHS Foundation Trust · GBStanford University · USUniversity Hospital of Zurich · CHUniversity of Chicago Medical Center · USUniversity of Michigan–Ann Arbor · USUPMC Hillman Cancer Center · USWest German Heart and Vascular Center Essen · DE

Funding

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
NCI NIH HHS P30 CA047904NCI NIH HHS P50 CA097190
6 · The paper itself

Abstract

objectivesWe report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN).

methodsPatients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017.

resultsWith 24.2 months' minimum follow-up, nivolumab (n = 240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression ≥1% (HR [95% CI] = 0.55 [0.39-0.78]) and  < 1% (HR [95% CI] = 0.73 [0.49-1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (<1%/≥1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3-4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively.

conclusionNivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status. (Clinicaltrials.gov: NCT02105636).

Indexed as

Neoplasm MetastasisNeoplasm Recurrence, LocalSurvival AnalysisAntineoplastic Agents, ImmunologicalB7-H1 AntigenHumansNivolumabSquamous Cell Carcinoma of Head and NeckAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanNivolumabCarcinoma, squamous cell of head and neckCD274 protein, human (PD-L1 Protein, Human)Clinical Trial, Phase IIIHead and Neck NeoplasmsImmunotherapyNivolumabPapillomaviridae (HPV, Human Papillomavirus Viruses)Programmed Cell Death 1 ReceptorSurvival AnalysisSurvivors (Long-term Survivors)

Identifiers

PMID29884413
PMCPMC6563923
OpenAlexW2799372507

What OpenQuestion holds

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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.