Evidence map›Paper›PMID 33989559›Full record

Trial reportThe Lancet. Oncology2021

Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, multi-arm, non-randomised, multicentre, phase 2 trial.

Assuntina G Sacco, Ruifeng Chen, Francis P Worden, Deborah J L Wong, Douglas Adkins, Paul Swiecicki, Wanxing Chai-Ho, Peter Oppelt, Debanjali Ghosh, Julie Bykowski and 9 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07733466 (Neoadjuvant Pembrolizumab Plus Cetuximab in Betel Nut-Associated Locally Advanced Oral Cavity Squamous Cell Carcinoma in the Commonwealth of the Northern Mariana Islands), which is not on this map. Cited by 162 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
162citing papers in PubMed, 7 pooled it
16.2field-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.

NCT07733466 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Neoadjuvant Pembrolizumab Plus Cetuximab in Betel Nut-Associated Locally Advanced Oral Cavity Squamous Cell Carcinoma in the Commonwealth of the Northern Mariana Islands: A Prospective, Open Label, Single Arm, Single Center, Non-randomized, Phase 2 Trial

TypeinterventionalSponsorPeter Brett, MDRan2026 to 2031Enrolled20ConditionsBetel-nut-associated Oral CarcinomaArmsPembrolizumab and cetuximab
3 · Its place in the literature

Who cites it

162 citing papers in PubMed, 7 syntheses or guidelines pooled it, 247 citations in OpenAlex.

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  15. Phase II (Alliance A091802) Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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102 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

19 authors at 5 institutions in 1 country.

Assuntina G SaccoMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA. Electronic address: agsacco@health.ucsd.edu.
Ruifeng ChenMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA; Division of Biostatistics, Herbert Wertheim School of Public Health, University of California, San Diego, La Jolla, CA, USA.
Francis P WordenRogel Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA.
Deborah J L WongLos Angeles Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.
Douglas AdkinsSiteman Comprehensive Cancer Center, Washington University, St Louis, MO, USA.
Paul SwiecickiRogel Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA.
Wanxing Chai-HoLos Angeles Jonsson Comprehensive Cancer Center, University of California, Los Angeles, Los Angeles, CA, USA.
Peter OppeltSiteman Comprehensive Cancer Center, Washington University, St Louis, MO, USA.
Debanjali GhoshMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
Julie BykowskiDepartment of Radiology, University of California, San Diego, La Jolla, CA, USA.
Alfredo MolinoloMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
Emily PittmanMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
M Valeria EstradaMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
Kathryn GoldMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
Gregory DanielsMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
Scott M LippmanMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
Amanda NatsuharaMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
Karen MesserMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA; Division of Biostatistics, Herbert Wertheim School of Public Health, University of California, San Diego, La Jolla, CA, USA.
Ezra E W CohenMoores Comprehensive Cancer Center, University of California, San Diego, La Jolla, CA, USA.
University of California, San Diego · USUniversity of California, Los Angeles · USWashington University in St. Louis · USMichigan Center for Translational Pathology · USUniversity of Michigan–Ann Arbor · US

Funding

VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DIANE M SIMEONE · 1985 to 2026
$124.9M
NCI NIH HHS P30 CA023100
6 · The paper itself

Abstract

backgroundPembrolizumab (PD-1 inhibitor) and cetuximab (EGFR inhibitor) are active as single agents and in combination with cytotoxic chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Given each drug's single agent activity and unique mechanism of action, we aimed to evaluate the anti-tumour activity of PD-1 blockade with EGFR inhibition in recurrent or metastatic HNSCC.

methodsThis study is an open-label, non-randomised, multi-arm, phase 2 trial done at four academic centres in the USA. Participants were required to have platinum-resistant or platinum-ineligible, recurrent or metastatic HNSCC, be at least 18 years old, have an Eastern Cooperative Oncology Group performance status 0-1, have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and to have received no previous immunotherapy or EGFR inhibition. All participants received pembrolizumab 200 mg intravenously every 3 weeks, combined with an initial loading dose of cetuximab 400 mg/m

findingsBetween March 22, 2017, and July 16, 2019, 33 participants were enrolled to cohort 1. All 33 participants received at least one dose of pembrolizumab. Median follow-up duration was 7·3 months (IQR 3·9-10·9). By 6 months, the overall response rate was 45% (95% CI 28-62), with 15 of 33 participants achieving a partial response. The most common grade 3-4 treatment-related adverse event was oral mucositis (three [9%] of 33 participants), and serious treatment-related adverse events occurred in five (15%) participants. No treatment-related deaths occurred.

interpretationPembrolizumab combined with cetuximab shows promising clinical activity for recurrent or metastatic HNSCC, and merits further investigation.

fundingMerck Sharp & Dohme.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCetuximabErbB ReceptorsFemaleHumansMaleMiddle AgedNeoplasm MetastasisProgrammed Cell Death 1 ReceptorSquamous Cell Carcinoma of Head and NeckAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanCetuximabEGFR protein, humanErbB ReceptorsPDCD1 protein, humanpembrolizumabProgrammed Cell Death 1 Receptor

Identifiers

PMID33989559
PMCPMC12140401
OpenAlexW3160114067

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.