Evidence map›Paper›PMID 41117857›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026

Long-term Survival and Molecular Biomarker Evaluation of a Phase II Cetuximab and Nivolumab Clinical Trial in Recurrent/Metastatic Head and Neck Cancer.

Ritu Chaudhary, Graydon Moorhead, Robin Park, Jiannong Li, Michael J Schell, Xiaofei Song, AikChoon Tan, Robbert J C Slebos, Maria I Biernacki, Samuel S Freeman and 13 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03370276 (A Phase I/II Study of Concurrent Cetuximab and Nivolumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03370276 phase1 / phase2completednot on this map

A Phase I/II Study of Concurrent Cetuximab and Nivolumab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2017 to 2023Enrolled95ConditionsSquamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the HypopharynxArmsNivolumab, Cetuximab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
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.

Ritu Chaudhary *Department of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0009-0007-9417-0340
Graydon Moorhead *Broad Institute of MIT and Harvard, Cambridge, Massachusetts.ORCID 0009-0007-7281-0693
Robin ParkDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-3004-3285
Jiannong LiDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.ORCID 0009-0004-9157-5447
Michael J SchellDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0003-4594-6601
Xiaofei SongDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-6585-7318
AikChoon TanHuntsman Cancer Institute, University of Utah, Salt Lake City, Utah.ORCID 0000-0003-2955-8369
Robbert J C SlebosDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0003-3117-9544
Maria I BiernackiDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0009-0004-8006-8036
Samuel S FreemanBroad Institute of MIT and Harvard, Cambridge, Massachusetts.ORCID 0000-0001-8285-0057
Sowjanya ThatikondaDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-5353-7202
Yeva MeshkovskaDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0009-0008-3240-8306
Juan Hernandez-PreraDepartment of Pathology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0003-0809-4649
Kedar KirtaneDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0003-1302-9577
Jose A Guevara-PatinoDepartment of Immunology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-6258-7228
Antonio L AmelioDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-6295-2694
James W RoccoOtolaryngology-Head and Neck Surgery, The Ohio State University Wexner Medical Center, James Cancer Hospital/Solove Research Institute, Columbus, Ohio.ORCID 0000-0001-5312-0303
Brian P DanyshBroad Institute of MIT and Harvard, Cambridge, Massachusetts.ORCID 0000-0001-6839-6337
Marcelo BonomiDepartment of Internal Medicine and The James Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.ORCID 0000-0002-9399-3608
Nabil F SabaDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia.ORCID 0000-0003-4972-1477
Nicholas J HaradhvalaBroad Institute of MIT and Harvard, Cambridge, Massachusetts.ORCID 0000-0003-1113-3135
Gad GetzBroad Institute of MIT and Harvard, Cambridge, Massachusetts.ORCID 0000-0002-0936-0753
Christine H ChungDepartment of Head and Neck-Endocrine Oncology, Moffitt Cancer Center, Tampa, Florida.ORCID 0000-0001-5199-4306

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI John L. Cleveland · 1998 to 2026
$93.5M
Decoding tobacco-related oral cancer ecosystem by integrative approachR01DE030508 · NIDCR · UNIVERSITY OF UTAH · PI CHUNG, CHRISTINE H, TAN, AIK CHOON · 2021 to 2023
$1.6M
Investigating the prognostic role of intrinsic immune evasion mechanisms in HNSCCR01DE030493 · NIDCR · H. LEE MOFFITT CANCER CTR & RES INST · PI WANG, XUEFENG · 2021 to 2023
$1.2M
Florida Department of Health (DOH) James and Esther King Biomedical Research Grant (21K04)National Cancer Institute (NCI) P30-CA076292National Institute of Dental and Craniofacial Research (NIDR) R01DE030493NCI NIH HHS P30 CA076292NIDCR NIH HHS R01 DE030493NIDCR NIH HHS R01 DE030508
6 · The paper itself

Abstract

purposeWe report long-term survival and comprehensive molecular biomarker analyses of a phase II trial evaluating the combination of cetuximab and nivolumab in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). PATIENTS AND

methodsThe long-term follow-up data were obtained from a phase II trial (NCT03370276). Archived tumors and serially collected plasma cell-free DNA were characterized by comprehensive genomic analyses. Immune markers were measured in tumor cores and margins by multiplex IHC.

resultsAt a median follow-up of 47.4 months, the median overall survival (OS) and 2-year OS rate were 12.7 months and 32% in all evaluable patients (n = 88) and 17.5 months and 35% in patients who had no prior therapy for R/M HNSCC (n = 43). The survival efficacy was similar between patients with p16-negative and p16-positive tumors, but the response rate was significantly higher in patients with p16-negative tumors. The clonal tumor mutational burden, hypoxia score, and EGFR pathway score were significantly higher in p16-negative compared with p16-positive tumors. Loss of heterozygosity of MHC class I was significantly more frequent in nonresponders, and APOBEC-associated mutagenesis was elevated in responders. Gene expression profiling and multiplex IHC analyses revealed a more inflamed tumor microenvironment in responders regardless of p16 status.

conclusionsOur long-term follow-up study indicates that the combination of cetuximab and nivolumab is efficacious and tolerable and that patients with p16-negative R/M HNSCC may have greater benefit from this combination.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorHead and Neck NeoplasmsNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckAdultAgedAged, 80 and overCetuximabFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisNivolumabBiomarkers, TumorCetuximabNivolumab

Identifiers

PMID41117857
PMCPMC12667737

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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.