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Cited by 1,745Cancer Immunotherapy and BiomarkersHead and Neck Cancer StudiesNonmelanoma Skin Cancer Studies

The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.

Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial

Seiwert, Tanguy Y, Burtness, Barbara, Mehra, Ranee, Weiss, Jared, Berger, Raanan, Eder, Joseph Paul, Heath, Karl, McClanahan, Terrill, Lunceford, Jared, Gause, Christine, Cheng, Jonathan D, Chow, Laura Q·2016·The Lancet Oncology
DOI 10.1016/s1470-2045(16)30066-3
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Abstract

Background Patients with recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options. We aimed to assess the safety, tolerability, and antitumour activity of pembrolizumab, a humanised anti-programmed death receptor 1 (PD-1) antibody, in patients with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck. Methods This study was an open-label, multicentre, phase 1b trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients were eligible for enrolment if they were aged 18 years or older, had a confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck, and had any level of PD-L1 expression (ie, at least 1% of tumour cells or stroma that were PD-L1-positive by immunohistochemistry). Patients received pembrolizumab 10 mg/kg intravenously every 2 weeks. Primary outcomes were safety in the per-protocol population and the proportion of patients with centrally reviewed overall response per Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1). Overall response was analysed in the full analysis set, which was defined as all patients who had received at least one dose of pembrolizumab, had measurable disease at baseline, and one post-baseline scan or patients without a post-baseline scan who discontinued therapy because of disease progression or a drug-related adverse event. The study is registered with ClinicalTrials.gov, number NCT…

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Crossref · 10.1016/s1470-2045(16)30066-3

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  1. Burtness, 2015, Moving forward in the management of squamous cell carcinoma of the head and neck: promising immuno-oncology approaches, Am J Hematol Oncol, 11, 28

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Metadata

Authors
Seiwert, T. Y., Burtness, B., Mehra, R., Weiss, J., Berger, R., Eder, J. P., Heath, K., McClanahan, T., Lunceford, J., Gause, C., Cheng, J. D., & Chow, L. Q.
Affiliations
  • University of Chicago (US)
  • Fox Chase Cancer Center (US)
  • University of North Carolina at Chapel Hill (US)
  • Sheba Medical Center (IL)
  • Yale Cancer Center (US)
  • Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
  • University of Washington (US)
Corresponding author
Seiwert, Tanguy Y
ORCID
Venue
The Lancet Oncology
Publisher
Elsevier BV
Published
2016-07
Volume
17
Issue
7
Pages
956-965
ISSN
1470-2045 (ISSN-L)
DOI
10.1016/s1470-2045(16)30066-3
OpenAlex
W2401455386
Cited by
1,745
References
0
Citations by year
2026: 73 · 2025: 136 · 2024: 149 · 2023: 159 · 2022: 165 · 2021: 213 · 2020: 195 · 2019: 190 · 2018: 216 · 2017: 204 · 2016: 44
FWCI
117.58
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet Oncology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Otorhinolaryngology › Head and Neck Cancer Studies
  • Health Sciences › Medicine › Dermatology › Nonmelanoma Skin Cancer Studies
Keywords
pembrolizumab, PD-1 inhibitors, PD-L1 expression, immune checkpoint inhibitors, antitumour activity, drug safety and tolerability, immune-related adverse events, hyponatremia, elevated liver enzymes, overall response rate
MeSH terms
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Carcinoma, Squamous Cell, Female, Follow-Up Studies, Head and Neck Neoplasms, Humans, Lymphatic Metastasis, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Prognosis, Safety, Survival Rate, Young Adult, Antibodies, Monoclonal, Humanized

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