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)
Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas for Medical Sciences — Little Rock, Arkansas
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (199 Sites)
Showing the first 25 of 199 sites.
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Fremont - Rideout Cancer Center — Marysville, California
- VA Palo Alto Health Care System — Palo Alto, California
- UCHealth Memorial Hospital Central — Colorado Springs, Colorado
- Memorial Hospital North — Colorado Springs, Colorado
- Poudre Valley Hospital — Fort Collins, Colorado
- Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado
- Lutheran Hospital - Cancer Centers of Colorado — Golden, Colorado
- UCHealth Greeley Hospital — Greeley, Colorado
- Medical Center of the Rockies — Loveland, Colorado
- Mount Sinai Medical Center — Miami Beach, Florida
- Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho
- Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho
- Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho
- Saint Alphonsus Cancer Care Center-Nampa — Nampa, Idaho
- Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho
- Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho
- Advocate Good Shepherd Hospital — Barrington, Illinois
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois
- Advocate Illinois Masonic Medical Center — Chicago, Illinois
- AMG Crystal Lake - Oncology — Crystal Lake, Illinois
- Carle at The Riverfront — Danville, Illinois
- Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois
- Decatur Memorial Hospital — Decatur, Illinois
- Advocate Good Samaritan Hospital — Downers Grove, Illinois
📞 Contact the Study Coordinator
Phone: (501) 686-8274
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Head and Neck Squamous Cell Carcinoma
- Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer — Houston, Texas
- Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery — Washington D.C., District of Columbia
- FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC — Birmingham, Alabama
Explore by condition: All Metastatic Head and Neck Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.