Evidence map›Paper›PMID 32583557›Full record

Trial reportHead & neck2020

Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator's choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141).

Chia-Jui Yen, Naomi Kiyota, Nobuhiro Hanai, Shunji Takahashi, Tomoya Yokota, Shigemichi Iwae, Yasushi Shimizu, Ruey-Long Hong, Masahiro Goto, Jin-Hyoung Kang and 6 more

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

Trial report in Head & neck, 2020. 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 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 10% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Identifying factors for pembrolizumab eligibility in head and neck cancer.Journal of cancer research and clinical oncology · 2025
    Article
  11. Observational
  12. Research progress of immunotherapy for advanced head and neck cancer.Medical oncology (Northwood, London, England) · 2024
    Review
  13. Immune Cells in Head-and-Neck Tumor Microenvironments.Journal of personalized medicine · 2022
    Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Observational
  19. Article
  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

16 authors at 16 institutions in 8 countries.

Chia-Jui YenDivision of Hematology and Oncology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Naomi KiyotaDepartment of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.ORCID 0000-0001-8021-6116
Nobuhiro HanaiDepartment of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
Shunji TakahashiDepartment of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Tomoya YokotaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Shigemichi IwaeDepartment of Head and Neck Surgery, Hyogo Cancer Center, Akashi, Japan.
Yasushi ShimizuDepartment of Medical Oncology, Hokkaido University Hospital, Sapporo, Japan.
Ruey-Long HongDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
Masahiro GotoCancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.
Jin-Hyoung KangDivision of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea.
Wing Sum Kenneth LiDepartment of Clinical Oncology, Queen Elizabeth Hospital, Hong Kong, China.
Robert L FerrisUPMC Hillman Cancer Center, University of Pittsburgh Medical Center Cancer Center, Pittsburgh, Pennsylvania, USA.ORCID 0000-0001-6605-2071
Maura GillisonDepartment of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, Texas, USA.
Toshimitsu EndoSection 1, Oncology Medical Affairs, ONO Pharmaceutical Co., Ltd, Osaka, Japan.ORCID 0000-0002-4398-4981
Vijayvel JayaprakashOncology Clinical Development, BMS, Bristol-Myers Squibb, Princeton, New Jersey, USA.
Makoto TaharaDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Aichi Cancer Center · JPBristol-Myers Squibb (Germany) · DEHokkaido University Hospital · JPHospital Authority · HKHyogo Prefectural Cancer Center · JPJapanese Foundation For Cancer Research · JPKobe University Hospital · JPNational Cancer Center Hospital East · JPNational Cheng Kung University Hospital · TWNational Taiwan University Hospital · TWOno Pharmaceutical (Japan) · JPOsaka Medical and Pharmaceutical University · JPShizuoka Cancer Center · JPThe Catholic University of Korea Seoul St. Mary's Hospital · KRThe University of Texas MD Anderson Cancer Center · USUPMC Hillman Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe present study evaluated the 2-year survival of the Asian population in the CheckMate 141 trial.

methodsThe CheckMate 141 trial included patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). In the present study, 34 Asian patients (nivolumab group: 23 patients; investigator's choice of therapy [IC] group: 11 patients) were analyzed.

resultsThe median overall survival (OS) was 12.1 and 6.2 months for the nivolumab and IC groups, respectively. The estimated 2-year OS rates were 22.7% and 0% for the nivolumab and IC groups, respectively. In the nivolumab group, the patients with any treatment-related adverse events (TRAEs), including skin-related disorders, showed better OS than the patients without any TRAEs.

conclusionsNivolumab demonstrated prolonged OS benefits in the Asian population with platinum-refractory R/M SCCHN and a favorable safety profile. TRAEs, including skin-related disorders, may be favorable prognostic factors for nivolumab efficacy. CLINICAL

trial registrationNCT02105636.

Indexed as

Head and Neck NeoplasmsNivolumabFollow-Up StudiesHumansNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckNivolumabAsian populationclinical trialimmunotherapynivolumabsquamous cell carcinoma of the head and neck

Identifiers

PMID32583557
PMCPMC7540331
OpenAlexW3037785217

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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.