Evidence map›Paper›PMID 35344035›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

Christine H Chung, Jiannong Li, Conor E Steuer, Priyanka Bhateja, Matthew Johnson, Jude Masannat, Maria I Poole, Feifei Song, Juan C Hernandez-Prera, Helen Molina and 13 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 4 pooled it
15.3field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 4 syntheses or guidelines pooled it, 81 citations in OpenAlex.

  1. Pooled it
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  7. Long-term Survival and Molecular Biomarker Evaluation of a Phase II Cetuximab and Nivolumab Clinical Trial in Recurrent/Metastatic Head and Neck Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  12. 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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4 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

23 authors at 5 institutions in 1 country.

Christine H ChungDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0001-5199-4306
Jiannong LiDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.
Conor E SteuerDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia.
Priyanka BhatejaDepartment of Internal Medicine and The James Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Matthew JohnsonDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.
Jude MasannatDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-5468-8213
Maria I PooleDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.
Feifei SongDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-4700-8064
Juan C Hernandez-PreraDepartment of Pathology, Moffitt Cancer Center, Tampa, Florida.
Helen MolinaDepartment of Pathology, Moffitt Cancer Center, Tampa, Florida.
Bruce M WenigDepartment of Pathology, Moffitt Cancer Center, Tampa, Florida.
Sunil KumarNaveris Inc., Natick, Massachusetts.ORCID 0000-0002-6282-0640
Charlotte KuperwasserNaveris Inc., Natick, Massachusetts.
Philip J StephensNaveris Inc., Natick, Massachusetts.
Joaquim M FarinhasDepartment of Radiology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0003-1040-7894
Dong M ShinDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia.
Julie A KishDepartment of Personalized Medicine, Moffitt Cancer Center, Tampa, Florida.
Jameel MuzaffarDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.
Kedar KirtaneDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0003-1302-9577
James W RoccoDepartment of Otolaryngology and The James Comprehensive Cancer Center, The Ohio State University Wexner Medical Center, Columbus, Ohio.ORCID 0000-0001-5312-0303
Michael J SchellDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.
Nabil F Saba *Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia.
Marcelo Bonomi *Department of Internal Medicine and The James Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Moffitt Cancer Center · USCombat Capabilities Development Command Soldier Center · USEmory University · USThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe Ohio State University Wexner Medical Center · US

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI David Darr · 1985 to 2026
$201.5M
Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA016058NCI NIH HHS P30 CA016086NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

purposeA phase II multi-institutional clinical trial was conducted to determine overall survival (OS) in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab and nivolumab. PATIENTS AND

methodsPatients with R/M HNSCC were treated with cetuximab 500 mg/m2 i.v. on day 14 as a lead-in followed by cetuximab 500 mg/m2 i.v. and nivolumab 240 mg i.v. on day 1 and day 15 of each 28-day cycle. Expression of p16 and programmed cell death-ligand 1 (PD-L1) in archived tumors were determined. Tumor-tissue-modified human papillomavirus (TTMV) DNA was quantified in plasma.

resultsNinety-five patients were enrolled, and 88 patients were evaluable for OS with a median follow-up of 15.9 months. Median OS in the 45 patients who had prior therapy for R/M HNSCC (cohort A) was 11.4 months, with a 1 year OS 50% [90% confidence interval (CI), 0.43-0.57]. Median OS in the 43 patients who had no prior therapy (cohort B) was 20.2 months, with a 1-year OS 66% (90% CI, 0.59-0.71). In the combined cohorts, the p16-negative immunostaining was associated with higher response rate (RR; P = 0.02) but did not impact survival while higher PD-L1 combined positive score was associated with higher RR (P = 0.03) and longer OS (log-rank P = 0.04). In the p16-positive patients, lower median (1,230 copies/mL) TTMV DNA counts were associated with higher RR (P = 0.01) and longer OS compared with higher median (log-rank P = 0.05).

conclusionsThe combination of cetuximab and nivolumab is effective in patients with both previously treated and untreated R/M HNSCC and warrants further evaluation.

Indexed as

Head and Neck NeoplasmsNivolumabB7-H1 AntigenCetuximabHumansNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckB7-H1 AntigenCetuximabNivolumab

Identifiers

PMID35344035
PMCPMC9167762
OpenAlexW4220722432

What OpenQuestion holds

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Registered trials

None linked

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.