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

PHASE3RecruitingINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

March 27, 2025

Primary Completion Date

November 30, 2029

Study Completion Date

November 30, 2029

Conditions
Metastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Neck Squamous Cell Carcinoma of Unknown PrimaryRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRefractory Head and Neck Squamous Cell CarcinomaRefractory Hypopharyngeal Squamous Cell CarcinomaRefractory Laryngeal Squamous Cell CarcinomaRefractory Oral Cavity Squamous Cell CarcinomaRefractory Oropharyngeal Squamous Cell CarcinomaStage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Cetuximab

Given IV

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Trial Locations (152)

12801

RECRUITING

Glens Falls Hospital, Glens Falls

13210

RECRUITING

State University of New York Upstate Medical University, Syracuse

13215

RECRUITING

SUNY Upstate Medical Center-Community Campus, Syracuse

13478

RECRUITING

Upstate Cancer Center at Verona, Verona

18017

RECRUITING

Lehigh Valley Hospital - Muhlenberg, Bethlehem

18103

RECRUITING

Lehigh Valley Hospital-Cedar Crest, Allentown

18301

RECRUITING

Pocono Medical Center, East Stroudsburg

19114

RECRUITING

Jefferson Torresdale Hospital, Philadelphia

21201

RECRUITING

University of Maryland/Greenebaum Cancer Center, Baltimore

23235

RECRUITING

VCU Massey Cancer Center at Stony Point, Richmond

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

25304

RECRUITING

West Virginia University Charleston Division, Charleston

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

28374

RECRUITING

FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst

28791

SUSPENDED

Margaret R Pardee Memorial Hospital, Hendersonville

43560

RECRUITING

ProMedica Flower Hospital, Sylvania

46307

RECRUITING

UChicago Medicine Northwest Indiana, Crown Point

48106

RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

48114

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton

48118

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea

48154

RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia

48188

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton

48197

RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti

48341

RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital, Pontiac

48503

RECRUITING

Cancer Hematology Centers - Flint, Flint

SUSPENDED

Genesee Hematology Oncology PC, Flint

RECRUITING

Genesys Hurley Cancer Institute, Flint

RECRUITING

Hurley Medical Center, Flint

48912

RECRUITING

University of Michigan Health - Sparrow Lansing, Lansing

50010

RECRUITING

Mary Greeley Medical Center, Ames

RECRUITING

McFarland Clinic - Ames, Ames

50036

RECRUITING

McFarland Clinic - Boone, Boone

50129

RECRUITING

McFarland Clinic - Jefferson, Jefferson

50158

RECRUITING

McFarland Clinic - Marshalltown, Marshalltown

50501

RECRUITING

McFarland Clinic - Trinity Cancer Center, Fort Dodge

52403

RECRUITING

Mercy Hospital, Cedar Rapids

RECRUITING

Oncology Associates at Mercy Medical Center, Cedar Rapids

53022

RECRUITING

Aurora Health Care Germantown Health Center, Germantown

53024

RECRUITING

Aurora Cancer Care-Grafton, Grafton

53066

RECRUITING

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

RECRUITING

Aurora Medical Center in Summit, Summit

53081

RECRUITING

Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan

53105

RECRUITING

Aurora Cancer Care-Southern Lakes VLCC, Burlington

53110

RECRUITING

Aurora Saint Luke's South Shore, Cudahy

53142

RECRUITING

Aurora Cancer Care-Kenosha South, Kenosha

53149

RECRUITING

ProHealth D N Greenwald Center, Mukwonago

53188

RECRUITING

ProHealth Waukesha Memorial Hospital, Waukesha

RECRUITING

UW Cancer Center at ProHealth Care, Waukesha

53209

RECRUITING

Aurora Cancer Care-Milwaukee, Milwaukee

53215

RECRUITING

Aurora Saint Luke's Medical Center, Milwaukee

53226

RECRUITING

Aurora Cancer Care-Milwaukee West, Wauwatosa

53227

RECRUITING

Aurora West Allis Medical Center, West Allis

53233

RECRUITING

Aurora Sinai Medical Center, Milwaukee

53406

RECRUITING

Aurora Cancer Care-Racine, Racine

54143

RECRUITING

Aurora Bay Area Medical Group-Marinette, Marinette

54241

RECRUITING

Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers

54311

RECRUITING

Aurora BayCare Medical Center, Green Bay

54601

RECRUITING

Gundersen Lutheran Medical Center, La Crosse

54904

RECRUITING

Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh

55101

RECRUITING

Regions Hospital, Saint Paul

55102

RECRUITING

United Hospital, Saint Paul

55109

RECRUITING

Saint John's Hospital - Healtheast, Maplewood

55407

RECRUITING

Abbott-Northwestern Hospital, Minneapolis

55416

RECRUITING

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park

55433

RECRUITING

Mercy Hospital, Coon Rapids

55435

RECRUITING

Fairview Southdale Hospital, Edina

56601

RECRUITING

Sanford Joe Lueken Cancer Center, Bemidji

57078

RECRUITING

Avera Cancer Institute at Yankton, Yankton

57104

RECRUITING

Sanford Cancer Center Oncology Clinic, Sioux Falls

57105

RECRUITING

Avera Cancer Institute, Sioux Falls

57301

RECRUITING

Avera Cancer Institute - Mitchell, Mitchell

57501

RECRUITING

Avera Cancer Institute at Pierre, Pierre

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

RECRUITING

Sanford Roger Maris Cancer Center, Fargo

58501

RECRUITING

Sanford Bismarck Medical Center, Bismarck

59101

RECRUITING

Billings Clinic Cancer Center, Billings

59405

RECRUITING

Benefis Sletten Cancer Institute, Great Falls

59711

RECRUITING

Community Hospital of Anaconda, Anaconda

59715

RECRUITING

Bozeman Health Deaconess Hospital, Bozeman

59804

RECRUITING

Community Medical Center, Missoula

59901

RECRUITING

Logan Health Medical Center, Kalispell

60010

RECRUITING

Advocate Good Shepherd Hospital, Barrington

60014

RECRUITING

AMG Crystal Lake - Oncology, Crystal Lake

60048

RECRUITING

AMG Libertyville - Oncology, Libertyville

RECRUITING

Condell Memorial Hospital, Libertyville

60068

RECRUITING

Advocate Lutheran General Hospital, Park Ridge

60123

RECRUITING

Advocate Sherman Hospital, Elgin

60429

RECRUITING

Advocate South Suburban Hospital, Hazel Crest

60451

RECRUITING

UC Comprehensive Cancer Center at Silver Cross, New Lenox

60453

RECRUITING

Advocate Outpatient Center - Oak Lawn, Oak Lawn

60462

RECRUITING

University of Chicago Medicine-Orland Park, Orland Park

60463

RECRUITING

Advocate High Tech Medical Park, Palos Heights

60515

RECRUITING

Advocate Good Samaritan Hospital, Downers Grove

60637

RECRUITING

University of Chicago Comprehensive Cancer Center, Chicago

60657

RECRUITING

Advocate Illinois Masonic Medical Center, Chicago

61114

RECRUITING

UW Health Carbone Cancer Center Rockford, Rockford

61455

RECRUITING

Illinois CancerCare-Macomb, Macomb

61615

RECRUITING

Illinois CancerCare-Peoria, Peoria

62269

RECRUITING

Cancer Care Center of O'Fallon, O'Fallon

RECRUITING

Memorial Hospital East, Shiloh

62401

RECRUITING

Crossroads Cancer Center, Effingham

62526

RECRUITING

Cancer Care Specialists of Illinois - Decatur, Decatur

RECRUITING

Decatur Memorial Hospital, Decatur

62702

RECRUITING

Southern Illinois University School of Medicine, Springfield

RECRUITING

Springfield Clinic, Springfield

62781

RECRUITING

Springfield Memorial Hospital, Springfield

63110

RECRUITING

Washington University School of Medicine, St Louis

63128

RECRUITING

Mercy Hospital South, St Louis

63129

RECRUITING

Siteman Cancer Center-South County, St Louis

63136

RECRUITING

Siteman Cancer Center at Christian Hospital, St Louis

63141

RECRUITING

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

RECRUITING

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

63703

RECRUITING

Saint Francis Medical Center, Cape Girardeau

64064

RECRUITING

University of Kansas Cancer Center - Lee's Summit, Lee's Summit

64108

RECRUITING

University Health Truman Medical Center, Kansas City

64154

RECRUITING

University of Kansas Cancer Center - North, Kansas City

65065

RECRUITING

Lake Regional Hospital, Osage Beach

66044

RECRUITING

Lawrence Memorial Hospital, Lawrence

66061

RECRUITING

The University of Kansas Cancer Center - Olathe, Olathe

66160

RECRUITING

University of Kansas Cancer Center, Kansas City

66205

RECRUITING

University of Kansas Hospital-Westwood Cancer Center, Westwood

66210

RECRUITING

University of Kansas Cancer Center-Overland Park, Overland Park

66211

RECRUITING

University of Kansas Hospital-Indian Creek Campus, Overland Park

66606

RECRUITING

University of Kansas Health System Saint Francis Campus, Topeka

67401

RECRUITING

Salina Regional Health Center, Salina

67601

RECRUITING

HaysMed, Hays

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

73505

RECRUITING

Cancer Centers of Southwest Oklahoma Research, Lawton

80401

RECRUITING

Lutheran Hospital - Cancer Centers of Colorado, Golden

80524

RECRUITING

Poudre Valley Hospital, Fort Collins

80528

RECRUITING

Cancer Care and Hematology-Fort Collins, Fort Collins

80538

RECRUITING

Medical Center of the Rockies, Loveland

80631

RECRUITING

UCHealth Greeley Hospital, Greeley

80909

RECRUITING

UCHealth Memorial Hospital Central, Colorado Springs

80920

RECRUITING

Memorial Hospital North, Colorado Springs

83605

RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell

83687

RECRUITING

Saint Alphonsus Cancer Care Center-Nampa, Nampa

83706

RECRUITING

Saint Alphonsus Cancer Care Center-Boise, Boise

83814

RECRUITING

Kootenai Health - Coeur d'Alene, Coeur d'Alene

83854

RECRUITING

Kootenai Clinic Cancer Services - Post Falls, Post Falls

83864

RECRUITING

Kootenai Clinic Cancer Services - Sandpoint, Sandpoint

94304

RECRUITING

VA Palo Alto Health Care System, Palo Alto

95901

RECRUITING

Fremont - Rideout Cancer Center, Marysville

97045

RECRUITING

Providence Willamette Falls Medical Center, Oregon City

97213

RECRUITING

Providence Portland Medical Center, Portland

97225

RECRUITING

Providence Saint Vincent Medical Center, Portland

97914

RECRUITING

Saint Alphonsus Cancer Care Center-Ontario, Ontario

60453-2699

RECRUITING

Advocate Christ Medical Center, Oak Lawn

08002

RECRUITING

Jefferson Cherry Hill Hospital, Cherry Hill

08080

RECRUITING

Sidney Kimmel Cancer Center Washington Township, Sewell

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH