Evidence map›Paper›PMID 28328302›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

Pembrolizumab for Platinum- and Cetuximab-Refractory Head and Neck Cancer: Results From a Single-Arm, Phase II Study.

Joshua Bauml, Tanguy Y Seiwert, David G Pfister, Francis Worden, Stephen V Liu, Jill Gilbert, Nabil F Saba, Jared Weiss, Lori Wirth, Ammar Sukari and 8 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 353 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
353citing papers in PubMed, 12 pooled it
35.6field-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.

NCT02255097 phase2completednot on this map

A Phase II Clinical Trial of Single Agent Pembrolizumab (MK-3475) in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Who Have Failed Platinum and Cetuximab

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2014 to 2021Enrolled172ConditionsHead and Neck Squamous Cell CarcinomaArmspembrolizumab
NCT05213884 phase2completednot on this mapstarted 2022, after this paper: background citation

A Phase II Trial of Induction and Adjuvant Camrelizumab Combined With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

TypeinterventionalSponsorChongqing University Cancer HospitalRan2022 to 2026Enrolled39ConditionsHead and Neck Squamous Cell CarcinomaArmsCamrelizumab, Concurrent cisplatin chemotherapy, Intensity-modulated radiotherapy (IMRT)
3 · Its place in the literature

Who cites it

353 citing papers in PubMed, 12 syntheses or guidelines pooled it, 643 citations in OpenAlex.

  1. Progress in immunotherapy for resectable head and neck squamous cell carcinoma.Medical oncology (Northwood, London, England) · 2025
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  14. 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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293 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 1 institution in 1 country.

Joshua BaumlJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Tanguy Y SeiwertJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
David G PfisterJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Francis WordenJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Stephen V LiuJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Jill GilbertJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Nabil F SabaJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Jared WeissJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Lori WirthJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Ammar SukariJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Hyunseok KangJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Michael K GibsonJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Erminia MassarelliJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Steven PowellJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Amy MeisterJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Xinxin ShuJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Jonathan D ChengJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Robert HaddadJoshua Bauml, University of Pennsylvania, Philadelphia, PA; Tanguy Y. Seiwert, University of Chicago, Chicago, IL; David G. Pfister, Memorial Sloan Kettering Cancer Center, New York, NY; Francis Worden, University of Michigan Comprehensive Cancer Center, Ann Arbor; Ammar Sukari, Karmanos Cancer Institute, Wayne State University, Detroit, MI; Stephen V. Liu, Georgetown University Hospital, Washington, DC; Jill Gilbert, Vanderbilt University School of Medicine, Nashville, TN; Nabil F. Saba, Winship Cancer Institute/Emory University, Atlanta, GA; Jared Weiss, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, NC; Lori Wirth, Massachusetts General Hospital; Robert Haddad, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Hyunseok Kang, Johns Hopkins University School of Medicine, Baltimore, MD; Michael K. Gibson, University Hospitals Cleveland Medical Center, Cleveland, OH; Erminia Massarelli, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven Powell, Sanford Health, Sioux Falls, SD; and Amy Meister, Xinxin Shu, and Jonathan D. Cheng, Merck & Co., Inc., Kenilworth, NJ.
Georgetown University · US

Funding

Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI STEPHEN W BYERS · 1990 to 2026
$71.5M
6 · The paper itself

Abstract

Purpose There are no approved treatments for recurrent/metastatic head and neck squamous cell carcinoma refractory to platinum and cetuximab. In the single-arm, phase II KEYNOTE-055 study, we evaluated pembrolizumab, an anti-programmed death 1 receptor antibody, in this platinum- and cetuximab-pretreated population with poor prognosis. Methods Eligibility stipulated disease progression within 6 months of platinum and cetuximab treatment. Patients received pembrolizumab 200 mg every 3 weeks. Imaging was performed every 6 to 9 weeks. Primary end points: overall response rate (Response Evaluation Criteria in Solid Tumors v1.1, central review) and safety. Efficacy was assessed in all dosed patients and in subgroups on the basis of programmed death ligand 1 (PD-L1) expression and human papillomavirus (HPV) status. Results Among 171 patients treated, 75% received two or more prior lines of therapy for metastatic disease, 82% were PD-L1 positive, and 22% were HPV positive. At the time of analysis, 109 patients (64%) experienced a treatment-related adverse event; 26 patients (15%) experienced a grade ≥ 3 event. Seven patients (4%) discontinued treatment, and one died of treatment-related adverse events. Overall response rate was 16% (95% CI, 11% to 23%), with a median duration of response of 8 months (range, 2+ to 12+ months); 75% of responses were ongoing at the time of analysis. Response rates were similar in all HPV and PD-L1 subgroups. Median progression-free survival was 2.1 months, and median overall survival was 8 months. Conclusion Pembrolizumab exhibited clinically meaningful antitumor activity and an acceptable safety profile in recurrent/metastatic head and neck squamous cell carcinoma previously treated with platinum and cetuximab.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenCarcinoma, Squamous CellCetuximabDisease-Free SurvivalDisease ProgressionFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm Recurrence, LocalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenCD274 protein, humanCetuximabpembrolizumabPlatinum Compounds

Identifiers

PMID28328302
PMCPMC5946724
OpenAlexW2602907503

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.