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
NCT04671667
This study is recruiting at 120 US sites in 27 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- 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
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- National Cancer Institute (NCI)
- Last updated on ClinicalTrials.gov
- October 14, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arkansas · 1
- University of Arkansas for Medical Sciences · Little Rock, AR
California · 6
- Kaiser Permanente-Anaheim · Anaheim, CA
- Kaiser Permanente-Bellflower · Bellflower, CA
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, CA
- Kaiser Permanente Los Angeles Medical Center · Los Angeles, CA
- Kaiser Permanente-Ontario · Ontario, CA
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, CA
Connecticut · 4
- Smilow Cancer Center/Yale-New Haven Hospital · New Haven, CT
- Yale University · New Haven, CT
- Smilow Cancer Hospital Care Center-Trumbull · Trumbull, CT
- Smilow Cancer Hospital Care Center - Waterford · Waterford, CT
District of Columbia · 1
- MedStar Washington Hospital Center · Washington D.C., DC
Florida · 8
- UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, FL
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, FL
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL
- UM Sylvester Comprehensive Cancer Center at Plantation · Plantation, FL
- Moffitt Cancer Center · Tampa, FL
- Moffitt Cancer Center - McKinley Campus · Tampa, FL
- Moffitt Cancer Center-International Plaza · Tampa, FL
- Moffitt Cancer Center at Wesley Chapel · Wesley Chapel, FL
Georgia · 2
- Emory Proton Therapy Center · Atlanta, GA
- Emory University Hospital Midtown · Atlanta, GA
Illinois · 17
- John H Stroger Jr Hospital of Cook County · Chicago, IL
- Northwestern University · Chicago, IL
- University of Illinois · Chicago, IL
- Carle at The Riverfront · Danville, IL
- Decatur Memorial Hospital · Decatur, IL
- Northwestern Medicine Cancer Center Kishwaukee · DeKalb, IL
- Carle Physician Group-Effingham · Effingham, IL
- Crossroads Cancer Center · Effingham, IL
- Northwestern Medicine Cancer Center Delnor · Geneva, IL
- Carle Physician Group-Mattoon/Charleston · Mattoon, IL
- Loyola University Medical Center · Maywood, IL
- HSHS Saint Elizabeth's Hospital · O'Fallon, IL
- Southern Illinois University School of Medicine · Springfield, IL
- Springfield Clinic · Springfield, IL
- Springfield Memorial Hospital · Springfield, IL
- Carle Cancer Center · Urbana, IL
- Northwestern Medicine Cancer Center Warrenville · Warrenville, IL
Iowa · 7
- UI Health Care Mission Cancer and Blood - Ankeny Clinic · Ankeny, IA
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic · Clive, IA
- Broadlawns Medical Center · Des Moines, IA
- Iowa Methodist Medical Center · Des Moines, IA
- UI Health Care Mission Cancer and Blood - Des Moines Clinic · Des Moines, IA
- UI Health Care Mission Cancer and Blood - Laurel Clinic · Des Moines, IA
- UI Health Care Mission Cancer and Blood - Waukee Clinic · Waukee, IA
Kentucky · 3
- University of Kentucky/Markey Cancer Center · Lexington, KY
- The James Graham Brown Cancer Center at University of Louisville · Louisville, KY
- UofL Health Medical Center Northeast · Louisville, KY
Maryland · 3
- University of Maryland/Greenebaum Cancer Center · Baltimore, MD
- Central Maryland Radiation Oncology in Howard County · Columbia, MD
- UM Baltimore Washington Medical Center/Tate Cancer Center · Glen Burnie, MD
Massachusetts · 1
- Tufts Medical Center · Boston, MA
Minnesota · 1
- Sanford Joe Lueken Cancer Center · Bemidji, MN
Missouri · 2
- Mercy Hospital Saint Louis · St Louis, MO
- Mercy Hospital South · St Louis, MO
Montana · 3
- Benefis Sletten Cancer Institute · Great Falls, MT
- Logan Health Medical Center · Kalispell, MT
- Community Medical Center · Missoula, MT
Nebraska · 1
- Nebraska Methodist Hospital · Omaha, NE
New York · 8
- Mount Sinai Chelsea · New York, NY
- Mount Sinai Hospital · New York, NY
- Mount Sinai Union Square · New York, NY
- University of Rochester · Rochester, NY
- Stony Brook University Medical Center · Stony Brook, NY
- Montefiore Medical Center - Moses Campus · The Bronx, NY
- Montefiore Medical Center-Einstein Campus · The Bronx, NY
- Wilmot Cancer Institute at Webster · Webster, NY
North Carolina · 3
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC
- Cone Health Cancer Center · Greensboro, NC
- Annie Penn Memorial Hospital · Reidsville, NC
North Dakota · 2
- Sanford Bismarck Medical Center · Bismarck, ND
- Sanford Roger Maris Cancer Center · Fargo, ND
Ohio · 7
- Miami Valley Hospital South · Centerville, OH
- Cleveland Clinic Foundation · Cleveland, OH
- Miami Valley Hospital North · Dayton, OH
- Premier Blood and Cancer Center · Dayton, OH
- Atrium Medical Center-Middletown Regional Hospital · Franklin, OH
- Miami Valley Cancer Care and Infusion · Greenville, OH
- Upper Valley Medical Center · Troy, OH
Oklahoma · 2
- Cancer Centers of Southwest Oklahoma Research · Lawton, OK
- University of Oklahoma Health Sciences Center · Oklahoma City, OK
Oregon · 3
- Providence Newberg Medical Center · Newberg, OR
- Providence Portland Medical Center · Portland, OR
- Providence Saint Vincent Medical Center · Portland, OR
Pennsylvania · 15
- UPMC Altoona · Altoona, PA
- Geisinger Medical Center · Danville, PA
- UPMC Hillman Cancer Center Erie · Erie, PA
- UPMC Cancer Center at UPMC Horizon · Farrell, PA
- IRMC Cancer Center · Indiana, PA
- Geisinger Medical Oncology-Lewisburg · Lewisburg, PA
- UPMC Hillman Cancer Center - New Castle · New Castle, PA
- Fox Chase Cancer Center · Philadelphia, PA
- Jefferson Torresdale Hospital · Philadelphia, PA
- Thomas Jefferson University Hospital · Philadelphia, PA
- UPMC Hillman Cancer Center · Pittsburgh, PA
- UPMC-Passavant Hospital · Pittsburgh, PA
- UPMC-Saint Margaret · Pittsburgh, PA
- Geisinger Wyoming Valley/Henry Cancer Center · Wilkes-Barre, PA
- UPMC Memorial · York, PA
South Carolina · 1
- Medical University of South Carolina · Charleston, SC
South Dakota · 3
- Avera Cancer Institute · Sioux Falls, SD
- Sanford USD Medical Center - Sioux Falls · Sioux Falls, SD
- Avera Cancer Institute at Yankton · Yankton, SD
Tennessee · 1
- Vanderbilt University/Ingram Cancer Center · Nashville, TN
Virginia · 2
- VCU Massey Cancer Center at Stony Point · Richmond, VA
- VCU Massey Comprehensive Cancer Center · Richmond, VA
Wisconsin · 13
- Aspirus Cancer Care-Antigo-Volm Cancer Center · Antigo, WI
- ThedaCare Regional Cancer Center · Appleton, WI
- Saint Vincent Hospital Cancer Center at Saint Mary's · Green Bay, WI
- Saint Vincent Hospital Cancer Center Green Bay · Green Bay, WI
- Froedtert Menomonee Falls Hospital · Menomonee Falls, WI
- Medical College of Wisconsin · Milwaukee, WI
- Drexel Town Square Health Center · Oak Creek, WI
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center · Rhinelander, WI
- Aspirus Cancer Care - Stevens Point · Stevens Point, WI
- Saint Vincent Hospital Cancer Center at Sturgeon Bay · Sturgeon Bay, WI
- Aspirus Cancer Care-Wausau · Wausau, WI
- Froedtert West Bend Hospital/Kraemer Cancer Center · West Bend, WI
- Aspirus Cancer Care - Wisconsin Rapids · Wisconsin Rapids, WI
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.