RECRUITING

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

Conditions

Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

Official Title

A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features

Quick Facts

Study Start:2021-04-27

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04671667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patient must be between 18 and 79 years of age * Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field * Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery * Patients must have high risk disease defined as: * Positive margins and/or extra nodal extension (ENE) * Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e. carcinoma in situ) at the margin is also considered positive * ENE may be either gross or microscopic * Patient must have a PD-L1 Combined Positive Score (CPS) \>= 1 in a Clinical Laboratory Improvement Act (CLIA) certified laboratory. Testing can be done locally as long as it is done in a CLIA certified laboratory. This testing must be on the tumor specimen from the resection of the patient's recurrent or second primary HNSCC * Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as \> 50% of the presurgical tumor volume having previously received a dose of \> 45 Gy as determined by the treating radiation oncologist * Patient must have completed prior radiation a minimum of 6 months prior to randomization * Patient must not have any evidence of distant disease based on baseline imaging done within 28 days prior to randomization * Patient must not have received anti-PD-1/PD-L1 therapy for recurrent disease. If the patient received anti-PD-1/PD-L1 therapy as part of initial upfront curative intent treatment (either as part of definitive non-surgical therapy or in the adjuvant setting) in the past, the last dosage of anti-PD-1/PD-L1 therapy must have been given greater than one year prior to randomization * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible * Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab or chemotherapy if the test done for eligibility/randomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Patient must not expect to conceive or father children by using by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment * Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained =\< 28 days prior to protocol randomization) * Platelets \>= 100,000/mcL (obtained =\< 28 days prior to protocol randomization) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (obtained =\< 28 days prior to protocol randomization) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3.0 x institutional ULN (obtained =\< 28 days prior to protocol randomization) * Creatinine clearance \> 30 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to protocol randomization) * Patient must not have a current active infection that requires systemic treatment at time of randomization * Patient must not have a history of non-infectious pneumonitis requiring steroids within 3 years prior to randomization * Patient must not have a history of solid organ transplant or stem cell transplant * Patient must not be on immunosuppressive medication within 7 days prior to randomization, EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent; c) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) * 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. Patients with New York Heart Association class III or IV heart failure are not eligible * Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed * Patient must not have severe hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients * Patient must not have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed * Patient must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as they have not been HIV-infected with a history of Kaposi sarcoma and/or multicentric Castleman disease * Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection * NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Patient must be between 18 and 79 years of age
* Patient must have locoregionally recurrent or second primary HNSCC (oral cavity, oropharynx, larynx, hypopharynx) in a previously radiated field
* Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery
* Patients must have high risk disease defined as:
* Positive margins and/or extra nodal extension (ENE)
* Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e. carcinoma in situ) at the margin is also considered positive
* ENE may be either gross or microscopic
* Patient must have a PD-L1 Combined Positive Score (CPS) \>= 1 in a Clinical Laboratory Improvement Act (CLIA) certified laboratory. Testing can be done locally as long as it is done in a CLIA certified laboratory. This testing must be on the tumor specimen from the resection of the patient's recurrent or second primary HNSCC
* Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as \> 50% of the presurgical tumor volume having previously received a dose of \> 45 Gy as determined by the treating radiation oncologist
* Patient must have completed prior radiation a minimum of 6 months prior to randomization
* Patient must not have any evidence of distant disease based on baseline imaging done within 28 days prior to randomization
* Patient must not have received anti-PD-1/PD-L1 therapy for recurrent disease. If the patient received anti-PD-1/PD-L1 therapy as part of initial upfront curative intent treatment (either as part of definitive non-surgical therapy or in the adjuvant setting) in the past, the last dosage of anti-PD-1/PD-L1 therapy must have been given greater than one year prior to randomization
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A urine or serum pregnancy test must be repeated within 72 hours prior to receiving the first dose of pembrolizumab or chemotherapy if the test done for eligibility/randomization is done outside of this 72 hour window. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* Patient must not expect to conceive or father children by using by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse while on study treatment, and continue for 120 days after the last dose of study treatment
* Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained =\< 28 days prior to protocol randomization)
* Platelets \>= 100,000/mcL (obtained =\< 28 days prior to protocol randomization)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (obtained =\< 28 days prior to protocol randomization)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3.0 x institutional ULN (obtained =\< 28 days prior to protocol randomization)
* Creatinine clearance \> 30 ml/min using the Cockcroft-Gault formula (obtained =\< 28 days prior to protocol randomization)
* Patient must not have a current active infection that requires systemic treatment at time of randomization
* Patient must not have a history of non-infectious pneumonitis requiring steroids within 3 years prior to randomization
* Patient must not have a history of solid organ transplant or stem cell transplant
* Patient must not be on immunosuppressive medication within 7 days prior to randomization, EXCEPT for the following: a) intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b) systemic corticosteroids at physiologic doses =\< 10 mg/day of prednisone or equivalent; c) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
* 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. Patients with New York Heart Association class III or IV heart failure are not eligible
* Patient must not have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed
* Patient must not have severe hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients
* Patient must not have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* Patient must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial as long as they have not been HIV-infected with a history of Kaposi sarcoma and/or multicentric Castleman disease
* Patient must not have a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
* NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Dan P Zandberg

PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Kaiser Permanente-Anaheim

Anaheim, California, 92806

United States

Kaiser Permanente-Bellflower

Bellflower, California, 90706

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

United States

Kaiser Permanente-Ontario

Ontario, California, 91761

United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661

United States

Sutter Roseville Medical Center

Roseville, California, 95661

United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510

United States

Yale University

New Haven, Connecticut, 06520

United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611

United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385

United States

MedStar Washington Hospital Center

Washington, District of Columbia, 20010

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Emory Proton Therapy Center

Atlanta, Georgia, 30308

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Memorial Health University Medical Center

Savannah, Georgia, 31404

United States

Northwestern University

Chicago, Illinois, 60611

United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612

United States

University of Illinois

Chicago, Illinois, 60612

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

The Carle Foundation Hospital

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Reid Health

Richmond, Indiana, 47374

United States

Mission Cancer and Blood - Ankeny

Ankeny, Iowa, 50023

United States

Heartland Oncology and Hematology LLP

Council Bluffs, Iowa, 51503

United States

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, 51503

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309

United States

Broadlawns Medical Center

Des Moines, Iowa, 50314

United States

Iowa Lutheran Hospital

Des Moines, Iowa, 50316

United States

Methodist West Hospital

West Des Moines, Iowa, 50266-7700

United States

University of Kansas Cancer Center

Kansas City, Kansas, 66160

United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210

United States

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205

United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202

United States

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245

United States

Maryland Proton Treatment Center

Baltimore, Maryland, 21201

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044

United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154

United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064

United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Logan Health Medical Center

Kalispell, Montana, 59901

United States

Community Medical Center

Missoula, Montana, 59804

United States

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

Omaha, Nebraska, 68114

United States

Nebraska Methodist Hospital

Omaha, Nebraska, 68114

United States

Oncology Associates PC

Omaha, Nebraska, 68114

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Mount Sinai Union Square

New York, New York, 10003

United States

Mount Sinai Chelsea

New York, New York, 10011

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Stony Brook University Medical Center

Stony Brook, New York, 11794

United States

Randolph Hospital

Asheboro, North Carolina, 27203

United States

Cone Health Cancer Center

Greensboro, North Carolina, 27403

United States

Annie Penn Memorial Hospital

Reidsville, North Carolina, 27320

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

Indu and Raj Soin Medical Center

Beavercreek, Ohio, 45431

United States

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Dayton Physician LLC - Englewood

Dayton, Ohio, 45415

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

Greater Dayton Cancer Center

Kettering, Ohio, 45409

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015

United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

United States

UPMC Memorial

York, Pennsylvania, 17408

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

Avera Cancer Institute at Yankton

Yankton, South Dakota, 57078

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

United States

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, 54701

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Dan P Zandberg, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-27

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2021-04-27

Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma