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NCT06589804 · ClinicalTrials.gov registry record · Phase 3

Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment

A Phase 3 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 3
Development phase
158
Enrollment target
20
Study locations

NCT06589804 is a Phase 3 study of Metastatic 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 158 participants, above the 120-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 6 states.

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The verdict

NCT06589804, a Phase 3 study of Metastatic 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 3
Development phase
158 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.

Conditions Studied

Metastatic Head-and-neck Squamous-cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Metastatic Hypopharyngeal Squamous Cell Carcinoma Metastatic Laryngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma Metastatic Oropharyngeal Squamous Cell Carcinoma Metastatic Oral Cavity Squamous Cell Carcinoma Recurrent Neck Squamous Cell Carcinoma of Unknown Primary

Interventions

  • BIOLOGICAL Pembrolizumab
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • BIOLOGICAL Cetuximab

Study Locations (20)

Colorado

  • UCHealth Memorial Hospital Central - Colorado Springs
  • Memorial Hospital North - Colorado Springs
  • Poudre Valley Hospital - Fort Collins
  • Cancer Care and Hematology-Fort Collins - Fort Collins
  • Lutheran Hospital - Cancer Centers of Colorado - Golden
  • UCHealth Greeley Hospital - Greeley
  • Medical Center of the Rockies - Loveland

Idaho

  • Saint Alphonsus Cancer Care Center-Boise - Boise
  • Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
  • Kootenai Health - Coeur d'Alene - Coeur d'Alene
  • Saint Alphonsus Cancer Care Center-Nampa - Nampa
  • Kootenai Clinic Cancer Services - Post Falls - Post Falls
  • Kootenai Clinic Cancer Services - Sandpoint - Sandpoint

Illinois

  • Advocate Good Shepherd Hospital - Barrington
  • University of Chicago Comprehensive Cancer Center - Chicago
  • Advocate Illinois Masonic Medical Center - Chicago

California

  • Fremont - Rideout Cancer Center - Marysville
  • VA Palo Alto Health Care System - Palo Alto

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

Florida

  • Mount Sinai Medical Center - Miami Beach

Trial Details

FieldValue
Enrollment Target 158 participants
Start Date 2025-03-27
Est. Completion 2029-11-30
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06589804

The ClinicalTrials.gov registry entry for NCT06589804 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 120-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (32% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT06589804 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Colorado, Idaho, Illinois.

Frequently Asked Questions

What is clinical trial NCT06589804 about?

NCT06589804 is a clinical study titled "Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment". This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary si...

What is the current status of trial NCT06589804?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 158 participants. The study started on 2025-03-27. Estimated completion is 2029-11-30.

What conditions does trial NCT06589804 study?

This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma.

What interventions are being tested in trial NCT06589804?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cetuximab (BIOLOGICAL).

Who is sponsoring clinical trial NCT06589804?

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

Where is trial NCT06589804 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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