Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

February 18, 2025

Primary Completion Date

August 14, 2031

Study Completion Date

August 14, 2031

Conditions
Recurrent Head and Neck Cutaneous Squamous Cell CarcinomaRecurrent Skin Squamous Cell CarcinomaResectable Head and Neck Cutaneous Squamous Cell CarcinomaResectable Skin Squamous Cell CarcinomaStage III Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
Interventions
PROCEDURE

Biospecimen Collection

Undergo collection of blood and/or plasma

BIOLOGICAL

Cemiplimab

Given IV

PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

RADIATION

Image Guided Radiation Therapy

Undergo IGRT

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Surgical Procedure

Undergo surgery per SOC

PROCEDURE

Surgical Procedure

Undergo response-adaptive surgery

Trial Locations (157)

2050

RECRUITING

Chris O'Brien Lifehouse, Camperdown

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10461

RECRUITING

Montefiore Medical Center-Einstein Campus, The Bronx

RECRUITING

Montefiore Medical Center-Weiler Hospital, The Bronx

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

10604

RECRUITING

Memorial Sloan Kettering Westchester, Harrison

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

11553

RECRUITING

Memorial Sloan Kettering Nassau, Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack, Commack

13210

RECRUITING

State University of New York Upstate Medical University, Syracuse

13215

RECRUITING

SUNY Upstate Medical Center-Community Campus, Syracuse

14580

RECRUITING

Wilmot Cancer Institute at Webster, Webster

14642

RECRUITING

University of Rochester, Rochester

15090

RECRUITING

Wexford Health and Wellness Pavilion, Wexford

15146

RECRUITING

Forbes Hospital, Monroeville

15212

RECRUITING

Allegheny General Hospital, Pittsburgh

15224

RECRUITING

West Penn Hospital, Pittsburgh

15232

RECRUITING

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

15901

RECRUITING

UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown

16505

RECRUITING

UPMC Hillman Cancer Center Erie, Erie

16544

RECRUITING

Saint Vincent Hospital, Erie

19107

RECRUITING

Thomas Jefferson University Hospital, Philadelphia

19111

RECRUITING

Fox Chase Cancer Center, Philadelphia

19317

RECRUITING

Christiana Care Health System-Concord Health Center, Chadds Ford

19713

RECRUITING

Helen F Graham Cancer Center, Newark

RECRUITING

Medical Oncology Hematology Consultants PA, Newark

22908

RECRUITING

University of Virginia Cancer Center, Charlottesville

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

27157

RECRUITING

Wake Forest University Health Sciences, Winston-Salem

27599

RECRUITING

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

27609

RECRUITING

Duke Cancer Center Raleigh, Raleigh

27710

RECRUITING

Duke University Medical Center, Durham

28002

RECRUITING

Atrium Health Stanly/LCI-Albemarle, Albemarle

28025

RECRUITING

Atrium Health Cabarrus/LCI-Concord, Concord

28054

RECRUITING

Levine Cancer Institute-Gaston, Gastonia

28112

RECRUITING

Atrium Health Union/LCI-Union, Monroe

28150

RECRUITING

Atrium Health Cleveland/LCI-Cleveland, Shelby

28203

RECRUITING

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28210

RECRUITING

Atrium Health Pineville/LCI-Pineville, Charlotte

28262

RECRUITING

Atrium Health University City/LCI-University, Charlotte

29425

RECRUITING

Medical University of South Carolina, Charleston

29730

RECRUITING

Rock Hill Radiation Therapy Center, Rock Hill

29732

RECRUITING

Levine Cancer Institute-Rock Hill, Rock Hill

30308

RECRUITING

Emory University Hospital Midtown, Atlanta

30322

RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

33136

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33146

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33166

RECRUITING

UM Sylvester Comprehensive Cancer Center at Doral, Doral

33176

RECRUITING

Miami Cancer Institute, Miami

RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall, Miami

33180

RECRUITING

UM Sylvester Comprehensive Cancer Center at Aventura, Aventura

33324

RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation

33442

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

33607

RECRUITING

Moffitt Cancer Center-International Plaza, Tampa

33612

RECRUITING

Moffitt Cancer Center - McKinley Campus, Tampa

RECRUITING

Moffitt Cancer Center, Tampa

34232

RECRUITING

Florida Cancer Specialists - Sarasota, Sarasota

34236

RECRUITING

Florida Cancer Specialists - Sarasota Downtown, Sarasota

34239

RECRUITING

First Physicians Group - Silverstein Institute at Floyd Street, Sarasota

RECRUITING

Sarasota Memorial Hospital, Sarasota

34243

RECRUITING

Sarasota Memorial Health Care Center at University Parkway, Sarasota

34275

RECRUITING

Sarasota Memorial Hospital-Venice, N. Venice

RECRUITING

Florida Cancer Specialists - Venice Pinebrook, Venice

35233

RECRUITING

University of Alabama at Birmingham Cancer Center, Birmingham

37232

RECRUITING

Vanderbilt University/Ingram Cancer Center, Nashville

40202

RECRUITING

The James Graham Brown Cancer Center at University of Louisville, Louisville

40245

RECRUITING

UofL Health Medical Center Northeast, Louisville

40536

RECRUITING

University of Kentucky/Markey Cancer Center, Lexington

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

44011

RECRUITING

UH Seidman Cancer Center at UH Avon Health Center, Avon

44060

RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor

44106

RECRUITING

Case Western Reserve University, Cleveland

44122

RECRUITING

UHHS-Chagrin Highlands Medical Center, Beachwood

45069

RECRUITING

University of Cincinnati Cancer Center-West Chester, West Chester

45219

RECRUITING

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

46032

RECRUITING

IU Health North Hospital, Carmel

46202

RECRUITING

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

46237

RECRUITING

Franciscan Health Indianapolis, Indianapolis

46526

RECRUITING

Goshen Center for Cancer Care, Goshen

48109

RECRUITING

University of Michigan Comprehensive Cancer Center, Ann Arbor

48116

RECRUITING

University of Michigan - Brighton Center for Specialty Care, Brighton

48202

RECRUITING

Henry Ford Hospital, Detroit

49503

RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

53051

RECRUITING

Froedtert Menomonee Falls Hospital, Menomonee Falls

53095

RECRUITING

Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend

53154

RECRUITING

Drexel Town Square Health Center, Oak Creek

53226

RECRUITING

Medical College of Wisconsin, Milwaukee

53705

RECRUITING

William S Middleton VA Medical Center, Madison

53718

RECRUITING

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center, Madison

53792

RECRUITING

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54449

RECRUITING

Marshfield Medical Center-Marshfield, Marshfield

54476

RECRUITING

Marshfield Medical Center - Weston, Weston

54601

RECRUITING

Gundersen Lutheran Medical Center, La Crosse

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

60115

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

RECRUITING

Northwestern Medicine Cancer Center Delnor, Geneva

60462

RECRUITING

Northwestern Medicine Orland Park, Orland Park

60555

RECRUITING

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

RECRUITING

Northwestern University, Chicago

60612

RECRUITING

Rush University Medical Center, Chicago

RECRUITING

University of Illinois, Chicago

62002

RECRUITING

Alton Memorial Hospital, Alton

62269

RECRUITING

Memorial Hospital East, Shiloh

63110

RECRUITING

Washington University School of Medicine, St Louis

63129

RECRUITING

Siteman Cancer Center-South County, 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

64064

RECRUITING

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

64154

RECRUITING

University of Kansas Cancer Center - North, Kansas City

65212

RECRUITING

MU Health - University Hospital/Ellis Fischel Cancer Center, Columbia

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

68114

RECRUITING

Nebraska Methodist Hospital, Omaha

68118

RECRUITING

Nebraska Medicine-Village Pointe, Omaha

68123

RECRUITING

Nebraska Medicine-Bellevue, Bellevue

68198

RECRUITING

University of Nebraska Medical Center, Omaha

70112

RECRUITING

University Medical Center New Orleans, New Orleans

70805

RECRUITING

LSU Health Baton Rouge-North Clinic, Baton Rouge

70808

RECRUITING

Our Lady of the Lake Physician Group, Baton Rouge

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

78229

RECRUITING

University of Texas Health Science Center at San Antonio, San Antonio

84112

RECRUITING

Huntsman Cancer Institute/University of Utah, Salt Lake City

87106

RECRUITING

University of New Mexico Cancer Center, Albuquerque

90025

RECRUITING

The Angeles Clinic and Research Institute - West Los Angeles Office, Los Angeles

90033

RECRUITING

USC / Norris Comprehensive Cancer Center, Los Angeles

90048

RECRUITING

Cedars Sinai Medical Center, Los Angeles

90211

RECRUITING

Tower Cancer Research Foundation, Beverly Hills

90505

RECRUITING

Torrance Memorial Physician Network - Cancer Care, Torrance

91010

RECRUITING

City of Hope Comprehensive Cancer Center, Duarte

91030

RECRUITING

City of Hope South Pasadena, South Pasadena

91786

RECRUITING

City of Hope Upland, Upland

92024

RECRUITING

UC San Diego Health System - Encinitas, Encinitas

92093

RECRUITING

UC San Diego Moores Cancer Center, La Jolla

92103

RECRUITING

UC San Diego Medical Center - Hillcrest, San Diego

92618

RECRUITING

City of Hope at Irvine Lennar, Irvine

93534

RECRUITING

City of Hope Antelope Valley, Lancaster

94304

RECRUITING

Stanford Cancer Institute Palo Alto, Palo Alto

95817

RECRUITING

University of California Davis Comprehensive Cancer Center, Sacramento

06830

RECRUITING

Smilow Cancer Hospital Care Center at Greenwich, Greenwich

06437

RECRUITING

Smilow Cancer Hospital Care Center - Guilford, Guilford

06520

RECRUITING

Yale University, New Haven

06611

RECRUITING

Smilow Cancer Hospital Care Center-Trumbull, Trumbull

06708

RECRUITING

Smilow Cancer Hospital-Waterbury Care Center, Waterbury

06385

RECRUITING

Smilow Cancer Hospital Care Center - Waterford, Waterford

03756

RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth, Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen, Montvale

17033-0850

RECRUITING

Penn State Milton S Hershey Medical Center, Hershey

05401

RECRUITING

University of Vermont Medical Center, Burlington

05405

RECRUITING

University of Vermont and State Agricultural College, Burlington

05819

RECRUITING

Dartmouth Cancer Center - North, Saint Johnsbury

M5G 2M9

RECRUITING

University Health Network-Princess Margaret Hospital, Toronto

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH