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
This study is recruiting at 191 US sites in 30 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Metastatic Head and Neck Squamous Cell Carcinoma
- Metastatic Hypopharyngeal Squamous Cell Carcinoma
- Metastatic Laryngeal Squamous Cell Carcinoma
- Metastatic Oral Cavity Squamous Cell Carcinoma
- Metastatic Oropharyngeal Squamous Cell Carcinoma
- Recurrent Head and Neck Squamous Cell Carcinoma
- Recurrent Hypopharyngeal Squamous Cell Carcinoma
- Recurrent Laryngeal Squamous Cell Carcinoma
- Recurrent Neck Squamous Cell Carcinoma of Unknown Primary
- Recurrent Oral Cavity Squamous Cell Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- Refractory Head and Neck Squamous Cell Carcinoma
- Refractory Hypopharyngeal Squamous Cell Carcinoma
- Refractory Laryngeal Squamous Cell Carcinoma
- Refractory Oral Cavity Squamous Cell Carcinoma
- Refractory Oropharyngeal Squamous Cell Carcinoma
- Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
- Stage IV Hypopharyngeal Carcinoma AJCC v8
- Stage IV Laryngeal Cancer AJCC v8
- Stage IV Lip and Oral Cavity Cancer AJCC v8
- Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- National Cancer Institute (NCI)
- Last updated on ClinicalTrials.gov
- October 14, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arkansas · 1
- University of Arkansas for Medical Sciences · Little Rock, AR
California · 1
- VA Palo Alto Health Care System · Palo Alto, CA
Colorado · 7
- Memorial Hospital North · Colorado Springs, CO
- UCHealth Memorial Hospital Central · Colorado Springs, CO
- Cancer Care and Hematology-Fort Collins · Fort Collins, CO
- Poudre Valley Hospital · Fort Collins, CO
- Lutheran Hospital - Cancer Centers of Colorado · Golden, CO
- UCHealth Greeley Hospital · Greeley, CO
- Medical Center of the Rockies · Loveland, CO
Florida · 2
- Mount Sinai Comprehensive Cancer Center at Aventura · Aventura, FL
- Mount Sinai Medical Center · Miami Beach, FL
Idaho · 6
- Saint Alphonsus Cancer Care Center-Boise · Boise, ID
- Saint Alphonsus Cancer Care Center-Caldwell · Caldwell, ID
- Kootenai Health - Coeur d'Alene · Coeur d'Alene, ID
- Saint Alphonsus Cancer Care Center-Nampa · Nampa, ID
- Kootenai Clinic Cancer Services - Post Falls · Post Falls, ID
- Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, ID
Illinois · 32
- Advocate Good Shepherd Hospital · Barrington, IL
- Advocate Illinois Masonic Medical Center · Chicago, IL
- University of Chicago Comprehensive Cancer Center · Chicago, IL
- AMG Crystal Lake - Oncology · Crystal Lake, IL
- Carle at The Riverfront · Danville, IL
- Cancer Care Specialists of Illinois - Decatur · Decatur, IL
- Decatur Memorial Hospital · Decatur, IL
- Advocate Good Samaritan Hospital · Downers Grove, IL
- Carle Physician Group-Effingham · Effingham, IL
- Crossroads Cancer Center · Effingham, IL
- Advocate Sherman Hospital · Elgin, IL
- Advocate South Suburban Hospital · Hazel Crest, IL
- AMG Libertyville - Oncology · Libertyville, IL
- Condell Memorial Hospital · Libertyville, IL
- Illinois CancerCare-Macomb · Macomb, IL
- Carle Physician Group-Mattoon/Charleston · Mattoon, IL
- UC Comprehensive Cancer Center at Silver Cross · New Lenox, IL
- Carle BroMenn Medical Center · Normal, IL
- Carle Cancer Institute Normal · Normal, IL
- Cancer Care Center of O'Fallon · O'Fallon, IL
- Advocate Christ Medical Center · Oak Lawn, IL
- Advocate Outpatient Center - Oak Lawn · Oak Lawn, IL
- University of Chicago Medicine-Orland Park · Orland Park, IL
- Advocate High Tech Medical Park · Palos Heights, IL
- Advocate Lutheran General Hospital · Park Ridge, IL
- Illinois CancerCare-Peoria · Peoria, IL
- UW Health Carbone Cancer Center Rockford · Rockford, IL
- Memorial Hospital East · Shiloh, IL
- Southern Illinois University School of Medicine · Springfield, IL
- Springfield Clinic · Springfield, IL
- Springfield Memorial Hospital · Springfield, IL
- Carle Cancer Center · Urbana, IL
Indiana · 1
- UChicago Medicine Northwest Indiana · Crown Point, IN
Iowa · 6
- Mary Greeley Medical Center · Ames, IA
- McFarland Clinic - Ames · Ames, IA
- Mercy Hospital · Cedar Rapids, IA
- Oncology Associates at Mercy Medical Center · Cedar Rapids, IA
- McFarland Clinic - Trinity Cancer Center · Fort Dodge, IA
- McFarland Clinic - Marshalltown · Marshalltown, IA
Kansas · 9
- HaysMed · Hays, KS
- University of Kansas Cancer Center · Kansas City, KS
- Lawrence Memorial Hospital · Lawrence, KS
- The University of Kansas Cancer Center - Olathe · Olathe, KS
- University of Kansas Cancer Center-Overland Park · Overland Park, KS
- University of Kansas Hospital-Indian Creek Campus · Overland Park, KS
- Salina Regional Health Center · Salina, KS
- University of Kansas Health System Saint Francis Campus · Topeka, KS
- University of Kansas Hospital-Westwood Cancer Center · Westwood, KS
Maryland · 1
- University of Maryland/Greenebaum Cancer Center · Baltimore, MD
Massachusetts · 1
- Boston Medical Center · Boston, MA
Michigan · 11
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor · Ann Arbor, MI
- Trinity Health IHA Medical Group Hematology Oncology - Brighton · Brighton, MI
- Trinity Health IHA Medical Group Hematology Oncology - Canton · Canton, MI
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital · Chelsea, MI
- Cancer Hematology Centers - Flint · Flint, MI
- Genesys Hurley Cancer Institute · Flint, MI
- Hurley Medical Center · Flint, MI
- University of Michigan Health - Sparrow Lansing · Lansing, MI
- Trinity Health Saint Mary Mercy Livonia Hospital · Livonia, MI
- Trinity Health Saint Joseph Mercy Oakland Hospital · Pontiac, MI
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus · Ypsilanti, MI
Minnesota · 10
- Sanford Joe Lueken Cancer Center · Bemidji, MN
- Minnesota Oncology - Burnsville · Burnsville, MN
- Mercy Hospital · Coon Rapids, MN
- Fairview Southdale Hospital · Edina, MN
- Saint John's Hospital - Healtheast · Maplewood, MN
- Abbott-Northwestern Hospital · Minneapolis, MN
- Hennepin County Medical Center · Minneapolis, MN
- Park Nicollet Clinic - Saint Louis Park · Saint Louis Park, MN
- Regions Hospital · Saint Paul, MN
- United Hospital · Saint Paul, MN
Missouri · 13
- Saint Francis Medical Center · Cape Girardeau, MO
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, MO
- Siteman Cancer Center at West County Hospital · Creve Coeur, MO
- University Health Truman Medical Center · Kansas City, MO
- University of Kansas Cancer Center - Briarcliff · Kansas City, MO
- University of Kansas Cancer Center - North · Kansas City, MO
- University of Kansas Cancer Center - Lee's Summit · Lee's Summit, MO
- Liberty Hospital · Liberty, MO
- Lake Regional Hospital · Osage Beach, MO
- Mercy Hospital South · St Louis, MO
- Siteman Cancer Center at Christian Hospital · St Louis, MO
- Siteman Cancer Center-South County · St Louis, MO
- Washington University School of Medicine · St Louis, MO
Montana · 6
- Community Hospital of Anaconda · Anaconda, MT
- Billings Clinic Cancer Center · Billings, MT
- Bozeman Health Deaconess Hospital · Bozeman, MT
- Benefis Sletten Cancer Institute · Great Falls, MT
- Logan Health Medical Center · Kalispell, MT
- Community Medical Center · Missoula, MT
New Hampshire · 1
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center · Lebanon, NH
New Jersey · 3
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, NJ
- Memorial Sloan Kettering Monmouth · Middletown, NJ
- Memorial Sloan Kettering Bergen · Montvale, NJ
New York · 7
- Memorial Sloan Kettering Commack · Commack, NY
- Memorial Sloan Kettering Westchester · Harrison, NY
- Memorial Sloan Kettering Cancer Center · New York, NY
- State University of New York Upstate Medical University · Syracuse, NY
- SUNY Upstate Medical Center-Community Campus · Syracuse, NY
- Memorial Sloan Kettering Nassau · Uniondale, NY
- Upstate Cancer Center at Verona · Verona, NY
North Carolina · 3
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC
- Margaret R Pardee Memorial Hospital · Hendersonville, NC
- FirstHealth of the Carolinas-Moore Regional Hospital · Pinehurst, NC
North Dakota · 3
- Sanford Bismarck Medical Center · Bismarck, ND
- Sanford Broadway Medical Center · Fargo, ND
- Sanford Roger Maris Cancer Center · Fargo, ND
Ohio · 7
- Miami Valley Hospital South · Centerville, OH
- Miami Valley Hospital · Dayton, OH
- Miami Valley Hospital North · Dayton, OH
- Atrium Medical Center-Middletown Regional Hospital · Franklin, OH
- Miami Valley Cancer Care and Infusion · Greenville, OH
- ProMedica Flower Hospital · Sylvania, OH
- Upper Valley Medical Center · Troy, OH
Oklahoma · 2
- Cancer Centers of Southwest Oklahoma Research · Lawton, OK
- University of Oklahoma Health Sciences Center · Oklahoma City, OK
Oregon · 4
- Saint Alphonsus Cancer Care Center-Ontario · Ontario, OR
- Providence Willamette Falls Medical Center · Oregon City, OR
- Providence Portland Medical Center · Portland, OR
- Providence Saint Vincent Medical Center · Portland, OR
Pennsylvania · 13
- Lehigh Valley Hospital-Cedar Crest · Allentown, PA
- Lehigh Valley Hospital - Muhlenberg · Bethlehem, PA
- Carlisle Regional Cancer Center · Carlisle, PA
- Pocono Medical Center · East Stroudsburg, PA
- UPMC Hillman Cancer Center Erie · Erie, PA
- UPMC Cancer Centers - Arnold Palmer Pavilion · Greensburg, PA
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus · Harrisburg, PA
- IRMC Cancer Center · Indiana, PA
- UPMC-Johnstown/John P. Murtha Regional Cancer Center · Johnstown, PA
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion · Mechanicsburg, PA
- UPMC Hillman Cancer Center - Monroeville · Monroeville, PA
- UPMC Hillman Cancer Center · Pittsburgh, PA
- UPMC-Passavant Hospital · Pittsburgh, PA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.