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NCT06980038 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
44
Enrollment target
3
Study locations

NCT06980038: Recruiting Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).

NCT06980038 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 44 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (62% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06980038, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
44 participants
Enrollment target
3
Study locations

Study Summary

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.

Primary Outcome

Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Descriptive statistics will be used.

Conditions Studied

Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma Oropharyngeal Squamous Cell Carcinoma Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Oral Cavity Squamous Cell Carcinoma Laryngeal Squamous Cell Carcinoma Hypopharyngeal Squamous Cell Carcinoma Nasal Cavity Squamous Cell Carcinoma Recurrent Nasal Cavity Squamous Cell Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • BIOLOGICAL Cemiplimab
  • BIOLOGICAL Anti-CD40 Agonist Monoclonal Antibody CDX-1140

Study Locations (3)

California

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange

Virginia

  • VCU Massey Comprehensive Cancer Center - Richmond

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2026-08-21
Est. Completion 2027-11-24
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT06980038 shows while recruiting

NCT06980038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (62% lower).

The record links to 10 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06980038 reports a single indexed study location in California, Virginia.

Frequently Asked Questions

What is clinical trial NCT06980038 about?

NCT06980038 is a clinical study titled "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". 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, a...

What is the current status of trial NCT06980038?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2026-08-21. Estimated completion is 2027-11-24.

What conditions does trial NCT06980038 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma.

What interventions are being tested in trial NCT06980038?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Cemiplimab (BIOLOGICAL), Anti-CD40 Agonist Monoclonal Antibody CDX-1140 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06980038?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06980038 being conducted?

This trial has 3 study locations across California, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Head and Neck Squamous Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06980038's enrollment target sits among peer trials

44 73rd of 124 higher than 52 of 124 other Head and Neck Squamous Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06980038

Source: ClinicalTrials.gov NCT06980038, the US trial registry maintained by the National Library of Medicine. NCT06980038 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.