Taking people in United StatesPhase 3

Adding cetuximab to pembrolizumab for head and neck cancer that returned or spread

Tests adding cetuximab to pembrolizumab in adults with returned or spreading head and neck cancer.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where: Allentown, Ames, Anaconda, Ann Arbor, Aventura, Baltimore, Barrington, Basking Ridge, Bemidji, Bethlehem, Billings, Bismarck, Boise, Boone, Boston, Bozeman, Brighton, Burlington, Burnsville, Caldwell, Canton, Cape Girardeau, Carlisle, Cedar Rapids, Centerville, Chapel Hill, Charleston, Chelsea, Cherry Hill, Chicago, City of Saint Peters, Coeur d'Alene, Colorado Springs, Commack, Coon Rapids, Creve Coeur, Crown Point, Crystal Lake, Cudahy, Danville, Dayton, Decatur, Downers Grove, East Stroudsburg, Eau Claire, Edina, Effingham, Elgin, Erie, Fargo, Flint, Fort Collins, Fort Dodge, Franklin, Germantown, Glens Falls, Golden, Grafton, Great Falls, Greeley, Green Bay, Greensburg, Greenville, Harrisburg, Harrison, Hays, Hazel Crest, Hendersonville, Indiana, Jefferson, Johnstown, Kalispell, Kansas City, Kenosha, La Crosse, Lansing, Lawrence, Lawton, Lebanon, Lee's Summit, Liberty, Libertyville, Little Rock, Livonia, Loveland, Macomb, Maplewood, Marinette, Marshalltown, Marshfield, Marysville, Mattoon, Mechanicsburg, Miami Beach, Middletown, Milwaukee, Minneapolis, Missoula, Mitchell, Monroeville, Montvale, Mukwonago, Nampa, New Lenox, New York, Normal, O'Fallon, Oak Lawn, Oconomowoc, Oklahoma City, Olathe, Ontario, Oregon City, Orland Park, Osage Beach, Oshkosh, Overland Park, Palo Alto, Palos Heights, Park Ridge, Peoria, Philadelphia, Pierre, Pinehurst, Pittsburgh, Pontiac, Portland, Post Falls, Racine, Rice Lake, Richmond, Rockford, Saint Johnsbury, Saint Louis Park, Saint Paul, Salina, Sandpoint, Seneca, Sewell, Sheboygan, Shiloh, Sioux Falls, Springfield, St Louis, Stevens Point, Summit, Sylvania, Syracuse, Topeka, Troy, Two Rivers, Uniondale, Uniontown, Urbana, Verona, Washington, Waukesha, Wauwatosa, West Allis, Weston, Westwood, Yankton, and Ypsilanti, United StatesSee the 202 sites
Phase: Phase 3

Where in United States

Lehigh Valley Hospital-Cedar CrestAllentown, United StatesTaking people
Mary Greeley Medical CenterAmes, United StatesTaking people
McFarland Clinic - AmesAmes, United StatesTaking people
Community Hospital of AnacondaAnaconda, United StatesTaking people
Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United StatesTaking people
Mount Sinai Comprehensive Cancer Center at AventuraAventura, United StatesTaking people
University of Maryland/Greenebaum Cancer CenterBaltimore, United StatesTaking people
Advocate Good Shepherd HospitalBarrington, United StatesTaking people
Memorial Sloan Kettering Basking RidgeBasking Ridge, United StatesTaking people
Sanford Joe Lueken Cancer CenterBemidji, United StatesTaking people
Lehigh Valley Hospital - MuhlenbergBethlehem, United StatesTaking people
Billings Clinic Cancer CenterBillings, United StatesTaking people
Sanford Bismarck Medical CenterBismarck, United StatesTaking people
Saint Alphonsus Cancer Care Center-BoiseBoise, United StatesTaking people
McFarland Clinic - BooneBoone, United StatesNo longer taking part
Boston Medical CenterBoston, United StatesTaking people
Bozeman Health Deaconess HospitalBozeman, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesTaking people
Aurora Cancer Care-Southern Lakes VLCCBurlington, United StatesTaking people
Minnesota Oncology - BurnsvilleBurnsville, United StatesTaking people
Saint Alphonsus Cancer Care Center-CaldwellCaldwell, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesTaking people
Saint Francis Medical CenterCape Girardeau, United StatesTaking people
Carlisle Regional Cancer CenterCarlisle, United StatesTaking people
Mercy HospitalCedar Rapids, United StatesTaking people
Oncology Associates at Mercy Medical CenterCedar Rapids, United StatesTaking people
Miami Valley Hospital SouthCenterville, United StatesTaking people
UNC Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
Medical University of South CarolinaCharleston, United StatesTaking people
Vandalia Health/CAMC Institute for Academic MedicineCharleston, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesTaking people
Jefferson Cherry Hill HospitalCherry Hill, United StatesNo longer taking part
Advocate Illinois Masonic Medical CenterChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, United StatesTaking people
Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesTaking people
Memorial Hospital NorthColorado Springs, United StatesTaking people
UCHealth Memorial Hospital CentralColorado Springs, United StatesTaking people
Memorial Sloan Kettering CommackCommack, United StatesTaking people
Mercy HospitalCoon Rapids, United StatesTaking people
Siteman Cancer Center at West County HospitalCreve Coeur, United StatesTaking people
UChicago Medicine Northwest IndianaCrown Point, United StatesTaking people
AMG Crystal Lake - OncologyCrystal Lake, United StatesTaking people
Aurora Saint Luke's South ShoreCudahy, United StatesTaking people
Carle at The RiverfrontDanville, United StatesTaking people
Miami Valley HospitalDayton, United StatesTaking people
Miami Valley Hospital NorthDayton, United StatesTaking people
Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
Decatur Memorial HospitalDecatur, United StatesTaking people
Advocate Good Samaritan HospitalDowners Grove, United StatesTaking people
Pocono Medical CenterEast Stroudsburg, United StatesTaking people
Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesTaking people
Fairview Southdale HospitalEdina, United StatesTaking people
Minnesota Oncology - EdinaEdina, United StatesTaking people
Carle Physician Group-EffinghamEffingham, United StatesTaking people
Crossroads Cancer CenterEffingham, United StatesTaking people
Advocate Sherman HospitalElgin, United StatesTaking people
UPMC Hillman Cancer Center ErieErie, United StatesTaking people
Sanford Broadway Medical CenterFargo, United StatesTaking people
Sanford Roger Maris Cancer CenterFargo, United StatesTaking people
Cancer Hematology Centers - FlintFlint, United StatesTaking people
Genesys Hurley Cancer InstituteFlint, United StatesTaking people
Hurley Medical CenterFlint, United StatesTaking people
Genesee Hematology Oncology PCFlint, United StatesNo longer taking part
Cancer Care and Hematology-Fort CollinsFort Collins, United StatesTaking people
Poudre Valley HospitalFort Collins, United StatesTaking people
McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesTaking people
Atrium Medical Center-Middletown Regional HospitalFranklin, United StatesTaking people
Aurora Health Care Germantown Health CenterGermantown, United StatesTaking people
Glens Falls HospitalGlens Falls, United StatesNo longer taking part
Lutheran Hospital - Cancer Centers of ColoradoGolden, United StatesTaking people
Aurora Cancer Care-GraftonGrafton, United StatesTaking people
Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
UCHealth Greeley HospitalGreeley, United StatesTaking people
Aurora BayCare Medical CenterGreen Bay, United StatesTaking people
UPMC Cancer Centers - Arnold Palmer PavilionGreensburg, United StatesTaking people
Miami Valley Cancer Care and InfusionGreenville, United StatesTaking people
UPMC Pinnacle Cancer Center/Community Osteopathic CampusHarrisburg, United StatesTaking people
Memorial Sloan Kettering WestchesterHarrison, United StatesTaking people
HaysMedHays, United StatesTaking people
Advocate South Suburban HospitalHazel Crest, United StatesTaking people
Margaret R Pardee Memorial HospitalHendersonville, United StatesTaking people
IRMC Cancer CenterIndiana, United StatesTaking people
McFarland Clinic - JeffersonJefferson, United StatesNo longer taking part
UPMC-Johnstown/John P. Murtha Regional Cancer CenterJohnstown, United StatesTaking people
Logan Health Medical CenterKalispell, United StatesTaking people
University Health Truman Medical CenterKansas City, United StatesTaking people
University of Kansas Cancer CenterKansas City, United StatesTaking people
University of Kansas Cancer Center - BriarcliffKansas City, United StatesTaking people
University of Kansas Cancer Center - NorthKansas City, United StatesTaking people
Aurora Cancer Care-Kenosha SouthKenosha, United StatesTaking people
Gundersen Lutheran Medical CenterLa Crosse, United StatesTaking people
University of Michigan Health - Sparrow LansingLansing, United StatesTaking people
Lawrence Memorial HospitalLawrence, United StatesTaking people
Cancer Centers of Southwest Oklahoma ResearchLawton, United StatesTaking people
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
University of Kansas Cancer Center - Lee's SummitLee's Summit, United StatesTaking people
Liberty HospitalLiberty, United StatesTaking people
AMG Libertyville - OncologyLibertyville, United StatesTaking people
Condell Memorial HospitalLibertyville, United StatesTaking people
University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesTaking people
Medical Center of the RockiesLoveland, United StatesTaking people
Illinois CancerCare-MacombMacomb, United StatesNo longer taking part
Saint John's Hospital - HealtheastMaplewood, United StatesTaking people
Aurora Bay Area Medical Group-MarinetteMarinette, United StatesTaking people
McFarland Clinic - MarshalltownMarshalltown, United StatesTaking people
Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
Fremont - Rideout Cancer CenterMarysville, United StatesNo longer taking part
Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionMechanicsburg, United StatesTaking people
Mount Sinai Medical CenterMiami Beach, United StatesTaking people
Memorial Sloan Kettering MonmouthMiddletown, United StatesTaking people
Aurora Cancer Care-MilwaukeeMilwaukee, United StatesTaking people
Aurora Saint Luke's Medical CenterMilwaukee, United StatesTaking people
Aurora Sinai Medical CenterMilwaukee, United StatesTaking people
Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
Hennepin County Medical CenterMinneapolis, United StatesTaking people
Community Medical CenterMissoula, United StatesTaking people
Avera Cancer Institute - MitchellMitchell, United StatesTaking people
UPMC Hillman Cancer Center - MonroevilleMonroeville, United StatesTaking people
Memorial Sloan Kettering BergenMontvale, United StatesTaking people
ProHealth D N Greenwald CenterMukwonago, United StatesTaking people
Saint Alphonsus Cancer Care Center-NampaNampa, United StatesTaking people
UC Comprehensive Cancer Center at Silver CrossNew Lenox, United StatesTaking people
Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
Carle BroMenn Medical CenterNormal, United StatesTaking people
Carle Cancer Institute NormalNormal, United StatesTaking people
Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
Advocate Christ Medical CenterOak Lawn, United StatesTaking people
Advocate Outpatient Center - Oak LawnOak Lawn, United StatesTaking people
ProHealth Oconomowoc Memorial HospitalOconomowoc, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
The University of Kansas Cancer Center - OlatheOlathe, United StatesTaking people
Saint Alphonsus Cancer Care Center-OntarioOntario, United StatesTaking people
Providence Willamette Falls Medical CenterOregon City, United StatesTaking people
University of Chicago Medicine-Orland ParkOrland Park, United StatesTaking people
Lake Regional HospitalOsage Beach, United StatesTaking people
Vince Lombardi Cancer Clinic - OshkoshOshkosh, United StatesTaking people
University of Kansas Cancer Center-Overland ParkOverland Park, United StatesTaking people
University of Kansas Hospital-Indian Creek CampusOverland Park, United StatesTaking people
VA Palo Alto Health Care SystemPalo Alto, United StatesTaking people
Advocate High Tech Medical ParkPalos Heights, United StatesTaking people
Advocate Lutheran General HospitalPark Ridge, United StatesTaking people
Illinois CancerCare-PeoriaPeoria, United StatesNo longer taking part
Jefferson Torresdale HospitalPhiladelphia, United StatesNo longer taking part
Avera Cancer Institute at PierrePierre, United StatesTaking people
FirstHealth of the Carolinas-Moore Regional HospitalPinehurst, United StatesTaking people
UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
UPMC-Passavant HospitalPittsburgh, United StatesTaking people
UPMC-Saint Clair Hospital Cancer CenterPittsburgh, United StatesTaking people
UPMC-Saint MargaretPittsburgh, United StatesTaking people
Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesTaking people
Providence Portland Medical CenterPortland, United StatesTaking people
Providence Saint Vincent Medical CenterPortland, United StatesTaking people
Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
Aurora Cancer Care-RacineRacine, United StatesTaking people
Marshfield Medical Center-Rice LakeRice Lake, United StatesTaking people
VCU Massey Cancer Center at Stony PointRichmond, United StatesTaking people
VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
UW Health Carbone Cancer Center RockfordRockford, United StatesTaking people
Dartmouth Cancer Center - NorthSaint Johnsbury, United StatesTaking people
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
Regions HospitalSaint Paul, United StatesTaking people
United HospitalSaint Paul, United StatesTaking people
Salina Regional Health CenterSalina, United StatesTaking people
Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
UPMC Cancer Center at UPMC NorthwestSeneca, United StatesTaking people
Sidney Kimmel Cancer Center Washington TownshipSewell, United StatesNo longer taking part
Vince Lombardi Cancer Clinic-SheboyganSheboygan, United StatesTaking people
Memorial Hospital EastShiloh, United StatesTaking people
Avera Cancer InstituteSioux Falls, United StatesTaking people
Sanford Cancer Center Oncology ClinicSioux Falls, United StatesTaking people
Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Springfield ClinicSpringfield, United StatesTaking people
Springfield Memorial HospitalSpringfield, United StatesTaking people
Mercy Hospital SouthSt Louis, United StatesTaking people
Siteman Cancer Center at Christian HospitalSt Louis, United StatesTaking people
Siteman Cancer Center-South CountySt Louis, United StatesTaking people
Washington University School of MedicineSt Louis, United StatesTaking people
Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
Aurora Medical Center in SummitSummit, United StatesTaking people
ProMedica Flower HospitalSylvania, United StatesTaking people
State University of New York Upstate Medical UniversitySyracuse, United StatesTaking people
SUNY Upstate Medical Center-Community CampusSyracuse, United StatesTaking people
University of Kansas Health System Saint Francis CampusTopeka, United StatesTaking people
Upper Valley Medical CenterTroy, United StatesTaking people
Vince Lombardi Cancer Clinic-Two RiversTwo Rivers, United StatesTaking people
Memorial Sloan Kettering NassauUniondale, United StatesTaking people
UPMC Cancer Center-UniontownUniontown, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
Upstate Cancer Center at VeronaVerona, United StatesTaking people
UPMC Cancer Center-WashingtonWashington, United StatesTaking people
ProHealth Waukesha Memorial HospitalWaukesha, United StatesTaking people
UW Cancer Center at ProHealth CareWaukesha, United StatesTaking people
Aurora Cancer Care-Milwaukee WestWauwatosa, United StatesTaking people
Aurora West Allis Medical CenterWest Allis, United StatesTaking people
Marshfield Medical Center - WestonWeston, United StatesTaking people
University of Kansas Hospital-Westwood Cancer CenterWestwood, United StatesTaking people
Avera Cancer Institute at YanktonYankton, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United StatesTaking people

Questions to ask the study team

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Trial details

Who runs it: National Cancer Institute (NCI)
Trial code: NCT06589804
Record updated: 6 November 2026
Original description: 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.Read full original descriptionShow less
Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease
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.
Inclusion: Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC); Previously untreated for recurrent and/or metastatic disease incurable by local therapies; Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx; Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair; Measurable disease; Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy; Patient must have a combined positive score PD-L1 positive (CPS >/= 1) tumor; Any radiation therapy must be completed >= 10 days prior to registration; Patients should not have received any prior treatment in the recurrent or metastatic setting; Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was >= 26 weeks prior to registration without evidence of disease progression during that treatment period; Patient has not received a live vaccine within 30 days prior to registration; Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3); Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration; Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH); Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available; Age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; Absolute neutrophil count (ANC) ≥ 1,500/mm\^3; Platelet count ≥ 100,000/mm\^3; Hemoglobin (Hgb) ≥ 9 g/dL (if < 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL); Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels > 1.5 x institutional ULN; Total bilirubin ≤ 1.5 x ULN OR direct bilirubin < ULN for participant with total bilirubin > 1.5 x institutional ULN; Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 3.0 x ULN unless liver metastases are present in which case < 5.0 x ULN; Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects; Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required; Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included; For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression; Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy; HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial; For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated; Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load; Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better; Patients does not have a history of active myocarditis; Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease; Patient does not have a history of solid organ transplantation.
ClinicalTrials.gov NCT06589804