Evidence map›Paper›PMID 31246283›Full record

Trial reportCancer2019

Nivolumab treatment beyond RECIST-defined progression in recurrent or metastatic squamous cell carcinoma of the head and neck in CheckMate 141: A subgroup analysis of a randomized phase 3 clinical trial.

Robert Haddad, Fernando Concha-Benavente, George Blumenschein, Jerome Fayette, Joel Guigay, A Dimitrios Colevas, Lisa Licitra, Stefan Kasper, Everett E Vokes, Francis Worden and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 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 63 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 3 pooled it
5.7field-weighted citation impact, top 3% 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

63 citing papers in PubMed, 3 syntheses or guidelines pooled it, 98 citations in OpenAlex.

  1. Progress in immunotherapy for resectable head and neck squamous cell carcinoma.Medical oncology (Northwood, London, England) · 2025
    Pooled it
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  7. Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2021
    Trial
  8. Review
  9. Doughnut-shaped bone lesions onAnnals of nuclear medicine · 2026
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3 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

18 authors at 14 institutions in 7 countries.

Robert HaddadDana-Farber/Harvard Cancer Center, Boston, Massachusetts.
Fernando Concha-BenaventeHillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
George BlumenscheinThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Jerome FayetteCentre Leon Berard, Lyon, France.
Joel GuigayCentre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France.
A Dimitrios ColevasStanford University, Stanford, California.
Lisa LicitraFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Stefan KasperWest German Cancer Center, University Hospital, Essen, Germany.
Everett E VokesUniversity of Chicago Medical Center, Chicago, Illinois.
Francis WordenUniversity of Michigan, Ann Arbor, Michigan.
Nabil F SabaWinship Cancer Institute, Emory University, Atlanta, Georgia.ORCID 0000-0003-4972-1477
Makoto TaharaNational Cancer Center Hospital East, Kashiwa, Japan.
Vijayvel JayaprakashBristol-Myers Squibb, Princeton, New Jersey.
Mark LynchBristol-Myers Squibb, Princeton, New Jersey.
Li LiBristol-Myers Squibb, Princeton, New Jersey.
Maura L GillisonThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Kevin J HarringtonNational Institute for Health Research Biomedical Research Centre, Royal Marsden/Institute of Cancer Research, London, United Kingdom.
Robert L FerrisHillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.ORCID 0000-0001-6605-2071
Bristol-Myers Squibb (United States) · USThe University of Texas MD Anderson Cancer Center · USUPMC Hillman Cancer Center · USCentre Léon Bérard · FRDana-Farber/Harvard Cancer Center · USEmory University · USInstitute of Cancer Research · GBNational Cancer Center Hospital East · JPStanford University · USUniversité Côte d'Azur · FRUniversity of Chicago Medical Center · USUniversity of Michigan · USUniversity of Milan · ITWest German Heart and Vascular Center Essen · DE

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
Bristol-Myers SquibbNCATS NIH HHS UL1 TR003167NCI NIH HHS P30 CA016672NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundResponse patterns with immune checkpoint inhibitors may be different from those with chemotherapy. Therefore, assessment of response to immunotherapy with the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, could result in premature treatment termination. The randomized, open-label, phase 3 CheckMate 141 trial (NCT02105636), which evaluated nivolumab in recurrent/metastatic squamous cell carcinoma of the head and neck after platinum therapy, allowed treatment beyond first RECIST-defined progression (TBP) according to protocol-specified criteria.

methodsIn CheckMate 141, patients with RECIST-defined progression who had a stable performance status and demonstrated clinical benefit without rapid disease progression were permitted to receive TBP with nivolumab at 3 mg/kg every 2 weeks until further progression, which was defined as an additional ≥10% increase in tumor volume. This post hoc analysis evaluated outcomes for patients who received TBP with nivolumab.

resultsOf 240 patients randomized to nivolumab, 146 experienced RECIST-defined progression. Sixty-two of these patients received TBP, and 84 discontinued treatment (no TBP). Among the 60 TBP patients evaluable for response, 15 (25%) had no change in their tumor burden, and 15 (25%) had reductions in target lesion size; 3 patients (5%) had reductions >30%. The median overall survival among TBP patients was 12.7 months (95% confidence interval, 9.7-14.6 months). No new safety signals were observed with TBP. Exploratory analyses of immune cell biomarkers suggested a potential relationship with initial and TBP responses.

conclusionsTumor burden reduction was noted in a proportion of patients who received TBP with nivolumab in CheckMate 141. Additional research is warranted to identify factors predictive of a TBP benefit in this population.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalDisease ProgressionFemaleHead and Neck NeoplasmsHumansLung NeoplasmsLymph NodesMaleMiddle AgedNeoplasm Recurrence, LocalNivolumabSquamous Cell Carcinoma of Head and NeckTreatment OutcomeAntineoplastic Agents, ImmunologicalNivolumabimmunotherapynivolumabphase 3 clinical trialssquamous cell carcinoma of the head and neck

Identifiers

PMID31246283
PMCPMC6771504
OpenAlexW2955839328

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.