Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

April 3, 2018

Primary Completion Date

September 20, 2022

Study Completion Date

September 4, 2025

Conditions
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell CarcinomaLaryngeal Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaOropharyngeal Squamous Cell CarcinomaPathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Squamous Cell Carcinoma of Unknown PrimaryStage III Hypopharyngeal Carcinoma AJCC v8Stage III Laryngeal Cancer AJCC v8Stage III Lip and Oral Cavity Cancer AJCC v8Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVA Hypopharyngeal Carcinoma AJCC v8Stage IVA Laryngeal Cancer AJCC v8Stage IVA Lip and Oral Cavity Cancer AJCC v8Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IVB Hypopharyngeal Carcinoma AJCC v8Stage IVB Laryngeal Cancer AJCC v8Stage IVB Lip and Oral Cavity Cancer AJCC v8Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
BIOLOGICAL

Cetuximab

Given IV

BIOLOGICAL

Durvalumab

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (256)

10016

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

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10467

Montefiore Medical Center - Moses Campus, The Bronx

10468

James J Peters VA Medical Center, The Bronx

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

11794

Stony Brook University Medical Center, Stony Brook

13210

State University of New York Upstate Medical University, Syracuse

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

15090

Wexford Health and Wellness Pavilion, Wexford

15146

Forbes Hospital, Monroeville

15212

Allegheny General Hospital, Pittsburgh

15232

UPMC-Shadyside Hospital, Pittsburgh

17044

Lewistown Hospital, Lewistown

17822

Geisinger Medical Center, Danville

17837

Geisinger Medical Oncology-Lewisburg, Lewisburg

18711

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

18840

Guthrie Medical Group PC-Robert Packer Hospital, Sayre

19001

Jefferson Abington Hospital, Abington

19008

Crozer-Keystone Regional Cancer Center at Broomall, Broomall

19090

Asplundh Cancer Pavilion, Willow Grove

19111

Fox Chase Cancer Center, Philadelphia

19140

Temple University Hospital, Philadelphia

19317

Christiana Care Health System-Concord Health Center, Chadds Ford

19611

Reading Hospital, West Reading

19713

Helen F Graham Cancer Center, Newark

19967

Beebe South Coastal Health Campus, Millville

19971

Beebe Health Campus, Rehoboth Beach

21204

Greater Baltimore Medical Center, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

23235

VCU Massey Cancer Center at Stony Point, Richmond

23298

VCU Massey Comprehensive Cancer Center, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

26506

West Virginia University Healthcare, Morgantown

27599

UNC Lineberger Comprehensive Cancer Center, Chapel Hill

28002

Atrium Health Stanly/LCI-Albemarle, Albemarle

28025

Atrium Health Cabarrus/LCI-Concord, Concord

28112

Atrium Health Union/LCI-Union, Monroe

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

28210

Atrium Health Pineville/LCI-Pineville, Charlotte

28791

Margaret R Pardee Memorial Hospital, Hendersonville

29303

Spartanburg Medical Center, Spartanburg

29425

Medical University of South Carolina, Charleston

29651

Gibbs Cancer Center-Pelham, Greer

29730

Rock Hill Radiation Therapy Center, Rock Hill

30303

Grady Health System, Atlanta

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30912

Augusta University Medical Center, Augusta

32207

Baptist MD Anderson Cancer Center, Jacksonville

33136

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

33146

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33442

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

33612

Moffitt Cancer Center, Tampa

35233

University of Alabama at Birmingham Cancer Center, Birmingham

36688

University of South Alabama Mitchell Cancer Institute, Mobile

40202

Norton Hospital Pavilion and Medical Campus, Louisville

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

40241

Norton Brownsboro Hospital and Medical Campus, Louisville

40536

University of Kentucky/Markey Cancer Center, Lexington

43210

Ohio State University Comprehensive Cancer Center, Columbus

43560

ProMedica Flower Hospital, Sylvania

44024

Geauga Hospital, Chardon

44060

UH Seidman Cancer Center at Lake Health Mentor Campus, Mentor

44106

Case Western Reserve University, Cleveland

44109

MetroHealth Medical Center, Cleveland

44145

UHHS-Westlake Medical Center, Westlake

44195

Cleveland Clinic Foundation, Cleveland

44691

Cleveland Clinic Wooster Family Health and Surgery Center, Wooster

44708

Cleveland Clinic Mercy Hospital, Canton

44710

Aultman Health Foundation, Canton

44870

North Coast Cancer Care, Sandusky

44906

Cleveland Clinic Cancer Center Mansfield, Mansfield

45069

University of Cincinnati Cancer Center-West Chester, West Chester

45219

University of Cincinnati Cancer Center-UC Medical Center, Cincinnati

46032

IU Health North Hospital, Carmel

46202

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis

Sidney and Lois Eskenazi Hospital, Indianapolis

46219

Community Cancer Center East, Indianapolis

46227

Community Cancer Center South, Indianapolis

46256

Community Cancer Center North, Indianapolis

46805

Parkview Hospital Randallia, Fort Wayne

46845

Parkview Regional Medical Center, Fort Wayne

48038

Henry Ford Macomb Hospital-Clinton Township, Clinton Township

48043

McLaren Cancer Institute-Macomb, Mount Clemens

48060

McLaren-Port Huron, Port Huron

48106

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48114

Trinity Health Medical Center - Brighton, Brighton

48118

Chelsea Hospital, Chelsea

48183

Henry Ford Cancer Institute-Downriver, Brownstown

48188

Trinity Health Medical Center - Canton, Canton

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48202

Henry Ford Hospital, Detroit

48322

Henry Ford West Bloomfield Hospital, West Bloomfield

48334

Weisberg Cancer Treatment Center, Farmington Hills

48346

McLaren Cancer Institute-Clarkston, Clarkston

48446

McLaren Cancer Institute-Lapeer Region, Lapeer

48532

McLaren Cancer Institute-Flint, Flint

Singh and Arora Hematology Oncology PC, Flint

48601

MyMichigan Medical Center Saginaw, Saginaw

48706

McLaren Cancer Institute-Bay City, Bay City

48910

Karmanos Cancer Institute at McLaren Greater Lansing, Lansing

48912

Mid-Michigan Physicians-Lansing, Lansing

University of Michigan Health - Sparrow Lansing, Lansing

49201

Allegiance Health, Jackson

49770

McLaren Cancer Institute-Northern Michigan, Petoskey

50309

Iowa Methodist Medical Center, Des Moines

50314

Mercy Medical Center - Des Moines, Des Moines

50325

Mercy Cancer Center-West Lakes, Clive

53038

University of Wisconsin Carbone Cancer Center - Johnson Creek, Johnson Creek

53051

Froedtert Menomonee Falls Hospital, Menomonee Falls

53066

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

Aurora Medical Center in Summit, Summit

53081

Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan

53095

Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend

53142

Aurora Cancer Care-Kenosha South, Kenosha

53149

ProHealth D N Greenwald Center, Mukwonago

53188

UW Cancer Center at ProHealth Care, Waukesha

53215

Aurora Saint Luke's Medical Center, Milwaukee

53226

Medical College of Wisconsin, Milwaukee

53227

Aurora West Allis Medical Center, West Allis

53295

Zablocki Veterans Administration Medical Center, Milwaukee

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

54143

Aurora Bay Area Medical Group-Marinette, Marinette

54301

Saint Vincent Hospital Cancer Center Green Bay, Green Bay

54303

Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay

54311

Aurora BayCare Medical Center, Green Bay

54401

Aspirus Regional Cancer Center, Wausau

54409

Langlade Hospital and Cancer Center, Antigo

54601

Gundersen Lutheran Medical Center, La Crosse

55101

Regions Hospital, Saint Paul

55337

Fairview Ridges Hospital, Burnsville

55415

Hennepin County Medical Center, Minneapolis

55432

Unity Hospital, Fridley

55435

Fairview Southdale Hospital, Edina

55805

Miller-Dwan Hospital, Duluth

55905

Mayo Clinic in Rochester, Rochester

56303

Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud

56601

Sanford Joe Lueken Cancer Center, Bemidji

57105

Avera Cancer Institute, Sioux Falls

58122

Sanford Roger Maris Cancer Center, Fargo

59101

Billings Clinic Cancer Center, Billings

59901

Logan Health Medical Center, Kalispell

60611

Northwestern University, Chicago

60612

John H Stroger Jr Hospital of Cook County, Chicago

Rush University Medical Center, Chicago

University of Illinois, Chicago

61401

Western Illinois Cancer Treatment Center, Galesburg

61636

Methodist Medical Center of Illinois, Peoria

61637

OSF Saint Francis Medical Center, Peoria

61801

Carle Cancer Center, Urbana

62401

Crossroads Cancer Center, Effingham

62526

Decatur Memorial Hospital, Decatur

62781

Springfield Memorial Hospital, Springfield

63110

Washington University School of Medicine, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

Mercy Hospital Saint Louis, St Louis

63376

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

63703

Saint Francis Medical Center, Cape Girardeau

66160

University of Kansas Cancer Center, Kansas City

66205

University of Kansas Hospital-Westwood Cancer Center, Westwood

66210

University of Kansas Cancer Center-Overland Park, Overland Park

67214

Ascension Via Christi Hospitals Wichita, Wichita

67401

Salina Regional Health Center, Salina

68803

Nebraska Cancer Specialists/Oncology Hematology West PC, Grand Island

70006

East Jefferson General Hospital, Metairie

73104

University of Oklahoma Health Sciences Center, Oklahoma City

77030

M D Anderson Cancer Center, Houston

80045

UCHealth University of Colorado Hospital, Aurora

80524

Poudre Valley Hospital, Fort Collins

80539

Banner McKee Medical Center, Loveland

80907

Penrose-Saint Francis Healthcare, Colorado Springs

80909

UCHealth Memorial Hospital Central, Colorado Springs

80920

Memorial Hospital North, Colorado Springs

83605

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell

83687

Saint Alphonsus Cancer Care Center-Nampa, Nampa

85234

Banner MD Anderson Cancer Center, Gilbert

85338

CTCA at Western Regional Medical Center, Goodyear

85719

Banner University Medical Center - Tucson, Tucson

University of Arizona Cancer Center-North Campus, Tucson

87106

University of New Mexico Cancer Center, Albuquerque

87109

New Mexico Oncology Hematology Consultants, Albuquerque

90048

Cedars Sinai Medical Center, Los Angeles

90505

Torrance Memorial Physician Network - Cancer Care, Torrance

90509

Torrance Memorial Medical Center, Torrance

91010

City of Hope Comprehensive Cancer Center, Duarte

91030

City of Hope South Pasadena, South Pasadena

92093

UC San Diego Moores Cancer Center, La Jolla

93720

Fresno Cancer Center, Fresno

Kaiser Permanente-Fresno, Fresno

94080

Kaiser Permanente Cancer Treatment Center, South San Francisco

Kaiser Permanente-South San Francisco, South San Francisco

94115

Kaiser Permanente-San Francisco, San Francisco

UCSF Medical Center-Mount Zion, San Francisco

94158

UCSF Medical Center-Mission Bay, San Francisco

94304

Stanford Cancer Institute Palo Alto, Palo Alto

VA Palo Alto Health Care System, Palo Alto

94531

Kaiser Permanente-Deer Valley Medical Center, Antioch

94538

Kaiser Permanente-Fremont, Fremont

94568

Kaiser Permanente Dublin, Dublin

94577

Kaiser Permanente San Leandro, San Leandro

94589

Kaiser Permanente-Vallejo, Vallejo

94596

Kaiser Permanente-Walnut Creek, Walnut Creek

94611

Kaiser Permanente Oakland-Broadway, Oakland

Kaiser Permanente-Oakland, Oakland

94704

Alta Bates Summit Medical Center-Herrick Campus, Berkeley

94801

Kaiser Permanente-Richmond, Richmond

94903

Kaiser San Rafael-Gallinas, San Rafael

94928

Rohnert Park Cancer Center, Rohnert Park

95051

Kaiser Permanente Medical Center - Santa Clara, Santa Clara

95119

Kaiser Permanente-Santa Teresa-San Jose, San Jose

95210

Kaiser Permanente-Stockton, Stockton

95356

Kaiser Permanente-Modesto, Modesto

95403

Kaiser Permanente-Santa Rosa, Santa Rosa

95603

Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn

95661

Kaiser Permanente-Roseville, Roseville

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville

95670

Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova

95678

The Permanente Medical Group-Roseville Radiation Oncology, Roseville

95688

Kaiser Permanente Medical Center-Vacaville, Vacaville

95814

Kaiser Permanente Downtown Commons, Sacramento

95816

Sutter Medical Center Sacramento, Sacramento

95817

University of California Davis Comprehensive Cancer Center, Sacramento

95823

Kaiser Permanente-South Sacramento, Sacramento

South Sacramento Cancer Center, Sacramento

96161

Gene Upshaw Memorial Tahoe Forest Cancer Center, Truckee

96813

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu

Queen's Medical Center, Honolulu

96817

The Cancer Center of Hawaii-Liliha, Honolulu

97213

Providence Portland Medical Center, Portland

97225

Providence Saint Vincent Medical Center, Portland

97227

Kaiser Permanente Northwest, Portland

97330

Good Samaritan Hospital, Corvallis

98195

University of Washington Medical Center - Montlake, Seattle

06518

Smilow Cancer Hospital-Hamden Care Center, Hamden

06520

Yale University, New Haven

06611

Smilow Cancer Hospital Care Center-Trumbull, Trumbull

06385

Smilow Cancer Hospital Care Center - Waterford, Waterford

02118

Boston Medical Center, Boston

01805

Lahey Hospital and Medical Center, Burlington

03756

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07601

Hackensack University Medical Center, Hackensack

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

17033-0850

Penn State Milton S Hershey Medical Center, Hershey

57117-5134

Sanford USD Medical Center - Sioux Falls, Sioux Falls

05819

Dartmouth Cancer Center - North, Saint Johnsbury

N6A 4L6

London Regional Cancer Program, London

M5G 2M9

University Health Network-Princess Margaret Hospital, Toronto

H3H 2R9

The Research Institute of the McGill University Health Centre (MUHC), Montreal

S4T 7T1

Allan Blair Cancer Centre, Regina

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Canadian Cancer Trials Group

NETWORK

collaborator

NRG Oncology

OTHER

lead

National Cancer Institute (NCI)

NIH