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Clinical trialNCT06980038RecruitingPhase 2Interventional

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

SponsorNational Cancer Institute (NCI)Enrollment44Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaNasal Cavity Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaOropharyngeal Squamous Cell Carcinoma+16 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial compares the effectiveness of cemiplimab with CDX-1140 to cemiplimab without CDX-1140 prior to surgery in treating patients with stage III-IV head and neck cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. CDX-1140 is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving cemiplimab with CDX-1140 versus cemiplimab alone before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed for patients with stage III-IV head and neck cancer.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, United States

    Victoria M. Villaflor
    Recruiting
  • Los Angeles General Medical Center

    Los Angeles, California, United States

    Jacob S. Thomas
    Recruiting
  • Uc Irvine Health/chao Family Comprehensive Cancer Center

    Orange, California, United States

    Victoria M. Villaflor
    Recruiting
  • Emory University Hospital Midtown

    Atlanta, Georgia, United States

    Jose A. Monteiro de Oliveira Novaes
    Recruiting
  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, United States

    Daniel Johnson
    Recruiting
  • University of Cincinnati Cancer Center-Uc Medical Center

    Cincinnati, Ohio, United States

    Chad A. Zender
    Recruiting
  • University of Cincinnati Cancer Center-West Chester

    West Chester, Ohio, United States

    Chad A. Zender
    Recruiting
  • Upmc Hillman Cancer Center

    Pittsburgh, Pennsylvania, United States

    Kevin J. Contrera
    Recruiting
  • Vcu Massey Comprehensive Cancer Center

    Richmond, Virginia, United States

    Erin R. Alesi
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Anti-CD40 Agonist Monoclonal Antibody CDX-1140Cemiplimab →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
27 May 2026
Primary completion
24 Nov 2027
Completion
24 Nov 2027
Last update posted
18 Aug 2026
Registered enrollment
44
Registry id
NCT06980038

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.