Could immunotherapy replace Chemo-Radiation after head and neck cancer surgery?

NCT ID NCT04671667

Recruiting now Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 9 times

Summary

This phase II trial is testing whether the immunotherapy drug pembrolizumab (Keytruda) alone can work better than the usual combination of chemotherapy and radiation after surgery for head and neck cancer that has come back or is a new primary tumor. About 188 adults aged 18-79 with high-risk features (like positive margins or cancer spread to lymph nodes) will be randomly assigned to receive either pembrolizumab or standard chemo-radiation. The study will compare overall survival, side effects, and disease-free survival to see if a gentler immunotherapy-only approach is effective.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: pembrolizumab (immunotherapy drug)
What this could lead to: If successful, this could offer a less toxic, immunotherapy-only option after surgery for recurrent head and neck cancer, potentially improving survival without the side effects of chemotherapy and radiation.
What could go wrong: This is a mid-stage trial with only 188 participants, so results may not apply to everyone. Pembrolizumab can cause immune-related side effects, and it may not work as well as the standard chemo-radiation approach.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma hypopharynx squamous cell carcinoma laryngeal squamous cell carcinoma oral cavity squamous cell carcinoma oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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

Contacts and locations

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Locations

Annie Penn Memorial Hospital
RECRUITING

Reidsville, North Carolina, 27320, United States
Aspirus Cancer Care - Stevens Point
RECRUITING

Stevens Point, Wisconsin, 54481, United States
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING

Wisconsin Rapids, Wisconsin, 54494, United States
Aspirus Cancer Care-Antigo-Volm Cancer Center
RECRUITING

Antigo, Wisconsin, 54409, United States
Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
RECRUITING

Rhinelander, Wisconsin, 54501, United States
Aspirus Cancer Care-Wausau
RECRUITING

Wausau, Wisconsin, 54401, United States
Atrium Medical Center-Middletown Regional Hospital
RECRUITING

Franklin, Ohio, 45005-1066, United States

Contact Email: •••••@•••••
Avera Cancer Institute
RECRUITING

Sioux Falls, South Dakota, 57105, United States

Contact Email: •••••@•••••
Avera Cancer Institute at Yankton
RECRUITING

Yankton, South Dakota, 57078, United States

Contact Email: •••••@•••••
Benefis Sletten Cancer Institute
RECRUITING

Great Falls, Montana, 59405, United States

Contact Email: •••••@•••••
Broadlawns Medical Center
RECRUITING

Des Moines, Iowa, 50314, United States
California Protons Cancer Therapy Center
ACTIVE_NOT_RECRUITING

San Diego, California, 92121, United States
Cancer Care Specialists of Illinois - Decatur
SUSPENDED

Decatur, Illinois, 62526, United States
Cancer Centers of Southwest Oklahoma Research
RECRUITING

Lawton, Oklahoma, 73505, United States
Carle Cancer Center
RECRUITING

Urbana, Illinois, 61801, United States

Contact Email: •••••@•••••
Carle Physician Group-Effingham
RECRUITING

Effingham, Illinois, 62401, United States

Contact Email: •••••@•••••
Carle Physician Group-Mattoon/Charleston
RECRUITING

Mattoon, Illinois, 61938, United States

Contact Email: •••••@•••••
Carle at The Riverfront
RECRUITING

Danville, Illinois, 61832, United States

Contact Email: •••••@•••••
Central Maryland Radiation Oncology in Howard County
RECRUITING

Columbia, Maryland, 21044, United States
Clackamas Radiation Oncology Center
SUSPENDED

Clackamas, Oregon, 97015, United States
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States

Contact Email: •••••@•••••
Community Medical Center
RECRUITING

Missoula, Montana, 59804, United States

Contact Email: •••••@•••••
Cone Health Cancer Center
RECRUITING

Greensboro, North Carolina, 27403, United States
Crossroads Cancer Center
RECRUITING

Effingham, Illinois, 62401, United States
Dayton Physician LLC - Englewood
ACTIVE_NOT_RECRUITING

Dayton, Ohio, 45415, United States
Dayton Physicians LLC-Atrium
ACTIVE_NOT_RECRUITING

Franklin, Ohio, 45005, United States
Dayton Physicians LLC-Miami Valley South
ACTIVE_NOT_RECRUITING

Centerville, Ohio, 45459, United States
Decatur Memorial Hospital
RECRUITING

Decatur, Illinois, 62526, United States
Drexel Town Square Health Center
RECRUITING

Oak Creek, Wisconsin, 53154, United States
Emory Proton Therapy Center
RECRUITING

Atlanta, Georgia, 30308, United States
Emory University Hospital Midtown
RECRUITING

Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
SUSPENDED

Atlanta, Georgia, 30322, United States
Fox Chase Cancer Center
RECRUITING

Philadelphia, Pennsylvania, 19111, United States
Froedtert Menomonee Falls Hospital
RECRUITING

Menomonee Falls, Wisconsin, 53051, United States
Froedtert West Bend Hospital/Kraemer Cancer Center
RECRUITING

West Bend, Wisconsin, 53095, United States
Geisinger Medical Center
RECRUITING

Danville, Pennsylvania, 17822, United States

Contact Email: •••••@•••••
Geisinger Medical Oncology-Lewisburg
RECRUITING

Lewisburg, Pennsylvania, 17837, United States

Contact Email: •••••@•••••
Geisinger Wyoming Valley/Henry Cancer Center
RECRUITING

Wilkes-Barre, Pennsylvania, 18711, United States

Contact Email: •••••@•••••
Greater Dayton Cancer Center
ACTIVE_NOT_RECRUITING

Kettering, Ohio, 45409, United States
HSHS Sacred Heart Hospital
ACTIVE_NOT_RECRUITING

Eau Claire, Wisconsin, 54701, United States
HSHS Saint Elizabeth's Hospital
RECRUITING

O'Fallon, Illinois, 62269, United States
Heartland Oncology and Hematology LLP
RECRUITING

Council Bluffs, Iowa, 51503, United States
Huntsman Cancer Institute/University of Utah
ACTIVE_NOT_RECRUITING

Salt Lake City, Utah, 84112, United States
IRMC Cancer Center
RECRUITING

Indiana, Pennsylvania, 15701, United States
Indu and Raj Soin Medical Center
ACTIVE_NOT_RECRUITING

Beavercreek, Ohio, 45431, United States
Iowa Lutheran Hospital
SUSPENDED

Des Moines, Iowa, 50316, United States
Iowa Methodist Medical Center
RECRUITING

Des Moines, Iowa, 50309, United States
Jefferson Torresdale Hospital
RECRUITING

Philadelphia, Pennsylvania, 19114, United States

Contact Email: •••••@•••••
John H Stroger Jr Hospital of Cook County
RECRUITING

Chicago, Illinois, 60612, United States
Kaiser Permanente Los Angeles Medical Center
RECRUITING

Los Angeles, California, 90027, United States

Contact Email: •••••@•••••
Kaiser Permanente-Anaheim
RECRUITING

Anaheim, California, 92806, United States

Contact Email: •••••@•••••
Kaiser Permanente-Bellflower
RECRUITING

Bellflower, California, 90706, United States

Contact Email: •••••@•••••
Kaiser Permanente-Ontario
RECRUITING

Ontario, California, 91761, United States

Contact Email: •••••@•••••
Kettering Medical Center
ACTIVE_NOT_RECRUITING

Kettering, Ohio, 45429, United States
Logan Health Medical Center
RECRUITING

Kalispell, Montana, 59901, United States

Contact Email: •••••@•••••
Loyola University Medical Center
RECRUITING

Maywood, Illinois, 60153, United States
Maryland Proton Treatment Center
SUSPENDED

Baltimore, Maryland, 21201, United States
MedStar Washington Hospital Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Medical University of South Carolina
RECRUITING

Charleston, South Carolina, 29425, United States
Memorial Health University Medical Center
SUSPENDED

Savannah, Georgia, 31404, United States
Memorial Sloan Kettering Basking Ridge
RECRUITING

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Bergen
RECRUITING

Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Memorial Sloan Kettering Commack
RECRUITING

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth
RECRUITING

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau
RECRUITING

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester
RECRUITING

Harrison, New York, 10604, United States
Mercy Hospital Saint Louis
RECRUITING

St Louis, Missouri, 63141, United States
Mercy Hospital South
RECRUITING

St Louis, Missouri, 63128, United States
Mercy Hospital Springfield
SUSPENDED

Springfield, Missouri, 65804, United States
Methodist Jennie Edmundson Hospital
RECRUITING

Council Bluffs, Iowa, 51503, United States
Methodist West Hospital
SUSPENDED

West Des Moines, Iowa, 50266-7700, United States
Miami Valley Cancer Care and Infusion
RECRUITING

Greenville, Ohio, 45331, United States
Miami Valley Hospital North
RECRUITING

Dayton, Ohio, 45415, United States

Contact Email: •••••@•••••
Miami Valley Hospital South
RECRUITING

Centerville, Ohio, 45459, United States

Contact Email: •••••@•••••
Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612, United States

Contact Email: •••••@•••••
Moffitt Cancer Center - McKinley Campus
RECRUITING

Tampa, Florida, 33612, United States

Contact Email: •••••@•••••
Moffitt Cancer Center at Wesley Chapel
RECRUITING

Wesley Chapel, Florida, 33544, United States

Contact Email: •••••@•••••
Moffitt Cancer Center-International Plaza
RECRUITING

Tampa, Florida, 33607, United States

Contact Email: •••••@•••••
Montefiore Medical Center - Moses Campus
RECRUITING

The Bronx, New York, 10467, United States
Montefiore Medical Center-Einstein Campus
RECRUITING

The Bronx, New York, 10461, United States
Mount Sinai Chelsea
RECRUITING

New York, New York, 10011, United States
Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
Mount Sinai Union Square
RECRUITING

New York, New York, 10003, United States
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
SUSPENDED

Omaha, Nebraska, 68114, United States
Nebraska Methodist Hospital
RECRUITING

Omaha, Nebraska, 68114, United States
Northwestern Medicine Cancer Center Delnor
RECRUITING

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Kishwaukee
RECRUITING

DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Warrenville
RECRUITING

Warrenville, Illinois, 60555, United States
Northwestern Medicine Lake Forest Hospital
ACTIVE_NOT_RECRUITING

Lake Forest, Illinois, 60045, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States

Contact Email: •••••@•••••
Oncology Associates PC
SUSPENDED

Omaha, Nebraska, 68114, United States
Premier Blood and Cancer Center
RECRUITING

Dayton, Ohio, 45409, United States
Providence Cancer Institute Clackamas Clinic
SUSPENDED

Clackamas, Oregon, 97015, United States
Providence Newberg Medical Center
RECRUITING

Newberg, Oregon, 97132, United States

Contact Email: •••••@•••••
Providence Portland Medical Center
RECRUITING

Portland, Oregon, 97213, United States

Contact Email: •••••@•••••
Providence Saint Vincent Medical Center
RECRUITING

Portland, Oregon, 97225, United States

Contact Email: •••••@•••••
Randolph Hospital
SUSPENDED

Asheboro, North Carolina, 27203, United States
Reid Health
ACTIVE_NOT_RECRUITING

Richmond, Indiana, 47374, United States
Saint Francis Medical Center
SUSPENDED

Cape Girardeau, Missouri, 63703, United States
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING

Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
RECRUITING

Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
RECRUITING

Sturgeon Bay, Wisconsin, 54235-1495, United States
Sanford Bismarck Medical Center
RECRUITING

Bismarck, North Dakota, 58501, United States

Contact Email: •••••@•••••
Sanford Joe Lueken Cancer Center
RECRUITING

Bemidji, Minnesota, 56601, United States

Contact Email: •••••@•••••
Sanford Roger Maris Cancer Center
RECRUITING

Fargo, North Dakota, 58122, United States

Contact Email: •••••@•••••
Sanford USD Medical Center - Sioux Falls
RECRUITING

Sioux Falls, South Dakota, 57117-5134, United States

Contact Email: •••••@•••••
Siteman Cancer Center at Christian Hospital
ACTIVE_NOT_RECRUITING

St Louis, Missouri, 63136, United States
Siteman Cancer Center at Saint Peters Hospital
ACTIVE_NOT_RECRUITING

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
ACTIVE_NOT_RECRUITING

Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center-South County
ACTIVE_NOT_RECRUITING

St Louis, Missouri, 63129, United States
Smilow Cancer Center/Yale-New Haven Hospital
RECRUITING

New Haven, Connecticut, 06510, United States

Contact Email: •••••@•••••
Smilow Cancer Hospital Care Center - Waterford
RECRUITING

Waterford, Connecticut, 06385, United States

Contact Email: •••••@•••••
Smilow Cancer Hospital Care Center-Trumbull
RECRUITING

Trumbull, Connecticut, 06611, United States

Contact Email: •••••@•••••
Southern Illinois University School of Medicine
RECRUITING

Springfield, Illinois, 62702, United States
Springfield Clinic
RECRUITING

Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
RECRUITING

Springfield, Illinois, 62781, United States
Stony Brook University Medical Center
RECRUITING

Stony Brook, New York, 11794, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
ACTIVE_NOT_RECRUITING

Roseville, California, 95661, United States
Sutter Roseville Medical Center
ACTIVE_NOT_RECRUITING

Roseville, California, 95661, United States
Temple University Hospital
ACTIVE_NOT_RECRUITING

Philadelphia, Pennsylvania, 19140, United States
The Carle Foundation Hospital
SUSPENDED

Urbana, Illinois, 61801, United States
The James Graham Brown Cancer Center at University of Louisville
RECRUITING

Louisville, Kentucky, 40202, United States
ThedaCare Regional Cancer Center
RECRUITING

Appleton, Wisconsin, 54911, United States

Contact Email: •••••@•••••
Thomas Jefferson University Hospital
RECRUITING

Philadelphia, Pennsylvania, 19107, United States

Contact Email: •••••@•••••
Tufts Medical Center
RECRUITING

Boston, Massachusetts, 02111, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITING

Orange, California, 92868, United States

Contact Email: •••••@•••••
UC San Diego Moores Cancer Center
ACTIVE_NOT_RECRUITING

La Jolla, California, 92093, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITING

Irvine, California, 92612, United States

Contact Email: •••••@•••••
UF Health Cancer Institute - Gainesville
ACTIVE_NOT_RECRUITING

Gainesville, Florida, 32610, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING

Ankeny, Iowa, 50023, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING

Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING

Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING

Waukee, Iowa, 50263, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING

Clive, Iowa, 50325, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
RECRUITING

Glen Burnie, Maryland, 21061, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITING

Plantation, Florida, 33324, United States
UNC Lineberger Comprehensive Cancer Center
RECRUITING

Chapel Hill, North Carolina, 27599, United States

Contact Email: •••••@•••••
UPMC Altoona
RECRUITING

Altoona, Pennsylvania, 16601, United States
UPMC Cancer Center at UPMC Horizon
RECRUITING

Farrell, Pennsylvania, 16121, United States
UPMC Hillman Cancer Center
RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
UPMC Hillman Cancer Center - New Castle
RECRUITING

New Castle, Pennsylvania, 16105, United States
UPMC Hillman Cancer Center Erie
RECRUITING

Erie, Pennsylvania, 16505, United States

Contact Email: •••••@•••••
UPMC Memorial
RECRUITING

York, Pennsylvania, 17408, United States
UPMC-Passavant Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Margaret
RECRUITING

Pittsburgh, Pennsylvania, 15215, United States
UPMC-Shadyside Hospital
ACTIVE_NOT_RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
University of Alabama at Birmingham Cancer Center
ACTIVE_NOT_RECRUITING

Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences
RECRUITING

Little Rock, Arkansas, 72205, United States
University of Illinois
RECRUITING

Chicago, Illinois, 60612, United States
University of Kansas Cancer Center
ACTIVE_NOT_RECRUITING

Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center - Lee's Summit
ACTIVE_NOT_RECRUITING

Lee's Summit, Missouri, 64064, United States
University of Kansas Cancer Center - North
ACTIVE_NOT_RECRUITING

Kansas City, Missouri, 64154, United States
University of Kansas Cancer Center at North Kansas City Hospital
ACTIVE_NOT_RECRUITING

North Kansas City, Missouri, 64116, United States
University of Kansas Cancer Center-Overland Park
ACTIVE_NOT_RECRUITING

Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Indian Creek Campus
ACTIVE_NOT_RECRUITING

Overland Park, Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center
ACTIVE_NOT_RECRUITING

Westwood, Kansas, 66205, United States
University of Kentucky/Markey Cancer Center
RECRUITING

Lexington, Kentucky, 40536, United States
University of Maryland/Greenebaum Cancer Center
RECRUITING

Baltimore, Maryland, 21201, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING

Miami, Florida, 33136, United States
University of Michigan Rogel Cancer Center
SUSPENDED

Ann Arbor, Michigan, 48109, United States
University of Mississippi Medical Center
SUSPENDED

Jackson, Mississippi, 39216, United States
University of New Mexico Cancer Center
ACTIVE_NOT_RECRUITING

Albuquerque, New Mexico, 87106, United States
University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Rochester
RECRUITING

Rochester, New York, 14642, United States
UofL Health Medical Center Northeast
RECRUITING

Louisville, Kentucky, 40245, United States

Contact Email: •••••@•••••
Upper Valley Medical Center
RECRUITING

Troy, Ohio, 45373, United States

Contact Email: •••••@•••••
VCU Massey Cancer Center at Stony Point
RECRUITING

Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
RECRUITING

Richmond, Virginia, 23298, United States
Vanderbilt University/Ingram Cancer Center
RECRUITING

Nashville, Tennessee, 37232, United States
Washington University School of Medicine
ACTIVE_NOT_RECRUITING

St Louis, Missouri, 63110, United States
Wayne State University/Karmanos Cancer Institute
ACTIVE_NOT_RECRUITING

Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center
ACTIVE_NOT_RECRUITING

Farmington Hills, Michigan, 48334, United States
Wilmot Cancer Institute at Webster
RECRUITING

Webster, New York, 14580, United States

Contact Email: •••••@•••••
Yale University
RECRUITING

New Haven, Connecticut, 06520, United States

Contact Email: •••••@•••••

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