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
Public ClinicalTrials.gov record NCT06589804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease
Study identification
- NCT ID
- NCT06589804
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- National Cancer Institute (NCI)
- NIH
- Enrollment
- 158 participants
Conditions and interventions
Conditions
- 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
Interventions
- Biospecimen Collection Procedure
- Cetuximab Biological
- Computed Tomography Procedure
- Magnetic Resonance Imaging Procedure
- Pembrolizumab Biological
- Positron Emission Tomography Procedure
Procedure · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 26, 2025
- Primary completion
- Nov 29, 2029
- Completion
- Nov 29, 2029
- Last update posted
- May 5, 2026
2025 – 2029
United States locations
- U.S. sites
- 177
- U.S. states
- 30
- U.S. cities
- 146
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | Recruiting |
| Fremont - Rideout Cancer Center | Marysville | California | 95901 | Active, not recruiting |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | Suspended |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | 80909 | Recruiting |
| Memorial Hospital North | Colorado Springs | Colorado | 80920 | Recruiting |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | Recruiting |
| Cancer Care and Hematology-Fort Collins | Fort Collins | Colorado | 80528 | Recruiting |
| Lutheran Hospital - Cancer Centers of Colorado | Golden | Colorado | 80401 | Recruiting |
| UCHealth Greeley Hospital | Greeley | Colorado | 80631 | Recruiting |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | Recruiting |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | Recruiting |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | Recruiting |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | 83605 | Recruiting |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | Recruiting |
| Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho | 83687 | Recruiting |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | Recruiting |
| Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho | 83864 | Recruiting |
| Advocate Good Shepherd Hospital | Barrington | Illinois | 60010 | Recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | Recruiting |
| Advocate Illinois Masonic Medical Center | Chicago | Illinois | 60657 | Recruiting |
| AMG Crystal Lake - Oncology | Crystal Lake | Illinois | 60014 | Recruiting |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | Recruiting |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | Recruiting |
| Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515 | Recruiting |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | Recruiting |
| Advocate Sherman Hospital | Elgin | Illinois | 60123 | Recruiting |
| Advocate South Suburban Hospital | Hazel Crest | Illinois | 60429 | Recruiting |
| AMG Libertyville - Oncology | Libertyville | Illinois | 60048 | Recruiting |
| Condell Memorial Hospital | Libertyville | Illinois | 60048 | Recruiting |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | Recruiting |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | Recruiting |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | Recruiting |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453-2699 | Recruiting |
| Advocate Outpatient Center - Oak Lawn | Oak Lawn | Illinois | 60453 | Recruiting |
| University of Chicago Medicine-Orland Park | Orland Park | Illinois | 60462 | Recruiting |
| Advocate High Tech Medical Park | Palos Heights | Illinois | 60463 | Recruiting |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | Recruiting |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | Recruiting |
| UW Health Carbone Cancer Center Rockford | Rockford | Illinois | 61114 | Recruiting |
| Memorial Hospital East | Shiloh | Illinois | 62269 | Recruiting |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | Recruiting |
| Springfield Clinic | Springfield | Illinois | 62702 | Recruiting |
| Springfield Memorial Hospital | Springfield | Illinois | 62781 | Recruiting |
| UChicago Medicine Northwest Indiana | Crown Point | Indiana | 46307 | Recruiting |
| Mary Greeley Medical Center | Ames | Iowa | 50010 | Recruiting |
| McFarland Clinic - Ames | Ames | Iowa | 50010 | Recruiting |
| McFarland Clinic - Boone | Boone | Iowa | 50036 | Suspended |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | Recruiting |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | Recruiting |
| McFarland Clinic - Trinity Cancer Center | Fort Dodge | Iowa | 50501 | Recruiting |
| McFarland Clinic - Jefferson | Jefferson | Iowa | 50129 | Suspended |
| McFarland Clinic - Marshalltown | Marshalltown | Iowa | 50158 | Recruiting |
| HaysMed | Hays | Kansas | 67601 | Recruiting |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | Recruiting |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | Recruiting |
| The University of Kansas Cancer Center - Olathe | Olathe | Kansas | 66061 | Recruiting |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | Recruiting |
| University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | 66211 | Recruiting |
| Salina Regional Health Center | Salina | Kansas | 67401 | Recruiting |
| University of Kansas Health System Saint Francis Campus | Topeka | Kansas | 66606 | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | Recruiting |
| Boston Medical Center | Boston | Massachusetts | 02118 | Recruiting |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | 48114 | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | 48188 | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | 48118 | Recruiting |
| Cancer Hematology Centers - Flint | Flint | Michigan | 48503 | Recruiting |
| Genesee Hematology Oncology PC | Flint | Michigan | 48503 | Suspended |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | Recruiting |
| Hurley Medical Center | Flint | Michigan | 48503 | Recruiting |
| University of Michigan Health - Sparrow Lansing | Lansing | Michigan | 48912 | Recruiting |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | Recruiting |
| Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | Recruiting |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | 48197 | Recruiting |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | Recruiting |
| Minnesota Oncology - Burnsville | Burnsville | Minnesota | 55337 | Recruiting |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | Recruiting |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | Recruiting |
| Saint John's Hospital - Healtheast | Maplewood | Minnesota | 55109 | Recruiting |
| Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | Recruiting |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | Recruiting |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | Recruiting |
| Regions Hospital | Saint Paul | Minnesota | 55101 | Recruiting |
| United Hospital | Saint Paul | Minnesota | 55102 | Recruiting |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | Recruiting |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | Recruiting |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | Recruiting |
| University Health Truman Medical Center | Kansas City | Missouri | 64108 | Recruiting |
| University of Kansas Cancer Center - Briarcliff | Kansas City | Missouri | 64116 | Recruiting |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | Recruiting |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | Recruiting |
| Lake Regional Hospital | Osage Beach | Missouri | 65065 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Mercy Hospital South | St Louis | Missouri | 63128 | Recruiting |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | Recruiting |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | Recruiting |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | Recruiting |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | Recruiting |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | Recruiting |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | Recruiting |
| Logan Health Medical Center | Kalispell | Montana | 59901 | Recruiting |
| Community Medical Center | Missoula | Montana | 59804 | Recruiting |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | Recruiting |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | Recruiting |
| Jefferson Cherry Hill Hospital | Cherry Hill | New Jersey | 08002 | Recruiting |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | Recruiting |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | Recruiting |
| Sidney Kimmel Cancer Center Washington Township | Sewell | New Jersey | 08080 | Recruiting |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | Recruiting |
| Glens Falls Hospital | Glens Falls | New York | 12801 | Recruiting |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | Recruiting |
| SUNY Upstate Medical Center-Community Campus | Syracuse | New York | 13215 | Recruiting |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | Recruiting |
| Upstate Cancer Center at Verona | Verona | New York | 13478 | Recruiting |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | Recruiting |
| Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | Recruiting |
| FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina | 28374 | Recruiting |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | Recruiting |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | Recruiting |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | 58122 | Recruiting |
| Miami Valley Hospital South | Centerville | Ohio | 45459 | Recruiting |
| Miami Valley Hospital | Dayton | Ohio | 45409 | Recruiting |
| Miami Valley Hospital North | Dayton | Ohio | 45415 | Recruiting |
| Atrium Medical Center-Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | Recruiting |
| Miami Valley Cancer Care and Infusion | Greenville | Ohio | 45331 | Recruiting |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | Recruiting |
| Upper Valley Medical Center | Troy | Ohio | 45373 | Recruiting |
| Cancer Centers of Southwest Oklahoma Research | Lawton | Oklahoma | 73505 | Recruiting |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Saint Alphonsus Cancer Care Center-Ontario | Ontario | Oregon | 97914 | Recruiting |
| Providence Willamette Falls Medical Center | Oregon City | Oregon | 97045 | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | 97213 | Recruiting |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | Recruiting |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | Recruiting |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | Recruiting |
| Pocono Medical Center | East Stroudsburg | Pennsylvania | 18301 | Recruiting |
| Jefferson Torresdale Hospital | Philadelphia | Pennsylvania | 19114 | Recruiting |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting |
| Avera Cancer Institute - Mitchell | Mitchell | South Dakota | 57301 | Recruiting |
| Avera Cancer Institute at Pierre | Pierre | South Dakota | 57501 | Recruiting |
| Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | 57104 | Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | Recruiting |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | Recruiting |
| Avera Cancer Institute at Yankton | Yankton | South Dakota | 57078 | Recruiting |
| Dartmouth Cancer Center - North | Saint Johnsbury | Vermont | 05819 | Recruiting |
| VCU Massey Cancer Center at Stony Point | Richmond | Virginia | 23235 | Recruiting |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | Recruiting |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | Recruiting |
| Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | 53105 | Recruiting |
| Aurora Saint Luke's South Shore | Cudahy | Wisconsin | 53110 | Recruiting |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | Recruiting |
| Aurora Health Care Germantown Health Center | Germantown | Wisconsin | 53022 | Recruiting |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | Recruiting |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | Recruiting |
| Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | 53142 | Recruiting |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | Recruiting |
| Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | 54143 | Recruiting |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | Recruiting |
| Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin | 53209 | Recruiting |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | Recruiting |
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | Recruiting |
| ProHealth D N Greenwald Center | Mukwonago | Wisconsin | 53149 | Recruiting |
| ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | 53066 | Recruiting |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | Recruiting |
| Aurora Cancer Care-Racine | Racine | Wisconsin | 53406 | Recruiting |
| Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | 53081 | Recruiting |
| Marshfield Medical Center-River Region at Stevens Point | Stevens Point | Wisconsin | 54482 | Recruiting |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | Recruiting |
| Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | 54241 | Recruiting |
| ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | Recruiting |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | Recruiting |
| Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | 53226 | Recruiting |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | Recruiting |
| Marshfield Medical Center - Weston | Weston | Wisconsin | 54476 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06589804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06589804 live on ClinicalTrials.gov.