Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck

PHASE3RecruitingINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

June 8, 2023

Primary Completion Date

March 31, 2029

Study Completion Date

March 31, 2030

Conditions
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaStage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck 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
DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT and/or PET/CT

DRUG

Fluorouracil

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiation therapy

Trial Locations (51)

11794

RECRUITING

Stony Brook University Medical Center, Stony Brook

14424

RECRUITING

Sands Cancer Center, Canandiaqua

14580

RECRUITING

Wilmot Cancer Institute at Webster, Webster

14606

RECRUITING

Wilmot Cancer Institute Radiation Oncology at Greece, Rochester

14620

RECRUITING

Highland Hospital, Rochester

14642

RECRUITING

University of Rochester, Rochester

19111

RECRUITING

Fox Chase Cancer Center, Philadelphia

23235

RECRUITING

VCU Massey Cancer Center at Stony Point, Richmond

23298

RECRUITING

Virginia Commonwealth University/Massey Cancer Center, Richmond

29425

RECRUITING

Medical University of South Carolina, Charleston

30308

RECRUITING

Emory University Hospital Midtown, Atlanta

33607

RECRUITING

Moffitt Cancer Center-International Plaza, Tampa

33612

RECRUITING

Moffitt Cancer Center - McKinley Campus, Tampa

RECRUITING

Moffitt Cancer Center, Tampa

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

50023

RECRUITING

Mission Cancer and Blood - Ankeny, Ankeny

50309

RECRUITING

Iowa Methodist Medical Center, Des Moines

RECRUITING

Mission Cancer and Blood - Des Moines, Des Moines

52403

RECRUITING

Mercy Hospital, Cedar Rapids

RECRUITING

Oncology Associates at Mercy Medical Center, Cedar Rapids

53066

RECRUITING

ProHealth Oconomowoc Memorial Hospital, Oconomowoc

53149

RECRUITING

ProHealth D N Greenwald Center, Mukwonago

53188

RECRUITING

UW Cancer Center at ProHealth Care, Waukesha

54401

RECRUITING

Aspirus Regional Cancer Center, Wausau

54409

RECRUITING

Langlade Hospital and Cancer Center, Antigo

54481

RECRUITING

Ascension Saint Michael's Hospital, Stevens Point

54494

RECRUITING

Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids

54501

RECRUITING

Ascension Saint Mary's Hospital, Rhinelander

54601

RECRUITING

Gundersen Lutheran Medical Center, La Crosse

56601

RECRUITING

Sanford Joe Lueken Cancer Center, Bemidji

57104

RECRUITING

Sanford Cancer Center Oncology Clinic, Sioux Falls

58122

RECRUITING

Sanford Broadway Medical Center, Fargo

RECRUITING

Sanford Roger Maris Cancer Center, Fargo

58501

RECRUITING

Sanford Bismarck Medical Center, Bismarck

60612

RECRUITING

University of Illinois, Chicago

61801

RECRUITING

Carle Cancer Center, Urbana

61832

RECRUITING

Carle at The Riverfront, Danville

61938

RECRUITING

Carle Physician Group-Mattoon/Charleston, Mattoon

62401

RECRUITING

Carle Physician Group-Effingham, Effingham

64804

RECRUITING

Freeman Health System, Joplin

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

83301

RECRUITING

Saint Luke's Cancer Institute - Twin Falls, Twin Falls

83619

RECRUITING

Saint Luke's Cancer Institute - Fruitland, Fruitland

83642

RECRUITING

Saint Luke's Cancer Institute - Meridian, Meridian

83686

RECRUITING

Saint Luke's Cancer Institute - Nampa, Nampa

83712

RECRUITING

Saint Luke's Cancer Institute - Boise, Boise

97132

RECRUITING

Providence Newberg Medical Center, Newberg

97225

RECRUITING

Providence Saint Vincent Medical Center, Portland

57117-5134

RECRUITING

Sanford USD Medical Center - Sioux Falls, Sioux Falls

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

ECOG-ACRIN Cancer Research Group

NETWORK