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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
NCT06589804 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2025-03-27 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 3 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Recurrent Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06589804 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Colorado, Idaho, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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: Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06589804?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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