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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT04671667

Registry updated: 2026-10-20
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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.

Interventions

  • Carboplatin (Drug)
    Given IV
  • Cisplatin (Drug)
    Given IV
  • Computed Tomography (Procedure)
    Undergo CT
  • Intensity-Modulated Radiation Therapy (Radiation)
    Undergo IMRT
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Pembrolizumab (Biological)
    Given IV
  • Proton Beam Radiation Therapy (Radiation)
    Undergo PBRT

Eligibility criteria

Inclusion 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 someone, regardless of 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

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

Locations

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
  • University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
  • Kaiser Permanente-Anaheim — Anaheim, California, United States
  • Kaiser Permanente-Bellflower — Bellflower, California, United States
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
  • Kaiser Permanente-Ontario — Ontario, California, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
  • Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
  • Sutter Roseville Medical Center — Roseville, California, United States
  • California Protons Cancer Therapy Center — San Diego, California, United States
  • Smilow Cancer Center/Yale-New Haven Hospital — New Haven, Connecticut, United States
  • Yale University — New Haven, Connecticut, United States
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
  • Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States
  • MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
  • UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
  • Moffitt Cancer Center-International Plaza — Tampa, Florida, United States
  • Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States
  • Moffitt Cancer Center — Tampa, Florida, United States
  • Moffitt Cancer Center at Wesley Chapel — Wesley Chapel, Florida, United States
  • Emory Proton Therapy Center — Atlanta, Georgia, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
  • Memorial Health University Medical Center — Savannah, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • John H Stroger Jr Hospital of Cook County — Chicago, Illinois, United States
  • University of Illinois — Chicago, Illinois, United States
  • Carle at The Riverfront — Danville, Illinois, United States
  • Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
  • Decatur Memorial Hospital — Decatur, Illinois, United States
  • Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States
  • Carle Physician Group-Effingham — Effingham, Illinois, United States
  • Crossroads Cancer Center — Effingham, Illinois, United States
  • Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
  • Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States
  • Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
  • Loyola University Medical Center — Maywood, Illinois, United States
  • HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois, United States
  • Southern Illinois University School of Medicine — Springfield, Illinois, United States
  • Springfield Clinic — Springfield, Illinois, United States
  • Springfield Memorial Hospital — Springfield, Illinois, United States
  • Carle Cancer Center — Urbana, Illinois, United States
  • The Carle Foundation Hospital — Urbana, Illinois, United States
  • Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
  • Reid Health — Richmond, Indiana, United States
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
  • Heartland Oncology and Hematology LLP — Council Bluffs, Iowa, United States
  • Methodist Jennie Edmundson Hospital — Council Bluffs, Iowa, United States
  • Iowa Methodist Medical Center — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
  • Broadlawns Medical Center — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
  • Iowa Lutheran Hospital — Des Moines, Iowa, United States
  • UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
  • Methodist West Hospital — West Des Moines, Iowa, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
  • University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • The James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
  • UofL Health Medical Center Northeast — Louisville, Kentucky, United States
  • Maryland Proton Treatment Center — Baltimore, Maryland, United States
  • University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
  • Central Maryland Radiation Oncology in Howard County — Columbia, Maryland, United States
  • UM Baltimore Washington Medical Center/Tate Cancer Center — Glen Burnie, Maryland, United States
  • Tufts Medical Center — Boston, Massachusetts, United States
  • University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
  • Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
  • Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States
  • Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
  • Saint Francis Medical Center — Cape Girardeau, Missouri, United States
  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
  • University of Kansas Cancer Center - North — Kansas City, Missouri, United States
  • University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
  • University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City, Missouri, United States
  • Mercy Hospital Springfield — Springfield, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Mercy Hospital South — St Louis, Missouri, United States
  • Siteman Cancer Center-South County — St Louis, Missouri, United States
  • Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
  • Mercy Hospital Saint Louis — St Louis, Missouri, United States
  • Benefis Sletten Cancer Institute — Great Falls, Montana, United States
  • Logan Health Medical Center — Kalispell, Montana, United States
  • Community Medical Center — Missoula, Montana, United States
  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC — Omaha, Nebraska, United States
  • Nebraska Methodist Hospital — Omaha, Nebraska, United States
  • Oncology Associates PC — Omaha, Nebraska, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial Sloan Kettering Westchester — Harrison, New York, United States
  • Mount Sinai Union Square — New York, New York, United States
  • Mount Sinai Chelsea — New York, New York, United States
  • Mount Sinai Hospital — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • Wilmot Cancer Institute at Webster — Webster, New York, United States
  • Randolph Hospital — Asheboro, North Carolina, United States
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
  • Cone Health Cancer Center — Greensboro, North Carolina, United States
  • Annie Penn Memorial Hospital — Reidsville, North Carolina, United States
  • Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
  • Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
  • Indu and Raj Soin Medical Center — Beavercreek, Ohio, United States
  • Dayton Physicians LLC-Miami Valley South — Centerville, Ohio, United States
  • Miami Valley Hospital South — Centerville, Ohio, United States
  • Cleveland Clinic Foundation — Cleveland, Ohio, United States
  • Premier Blood and Cancer Center — Dayton, Ohio, United States
  • Dayton Physician LLC - Englewood — Dayton, Ohio, United States
  • Miami Valley Hospital North — Dayton, Ohio, United States
  • Atrium Medical Center-Middletown Regional Hospital — Franklin, Ohio, United States
  • Dayton Physicians LLC-Atrium — Franklin, Ohio, United States
  • Miami Valley Cancer Care and Infusion — Greenville, Ohio, United States
  • Greater Dayton Cancer Center — Kettering, Ohio, United States
  • Kettering Medical Center — Kettering, Ohio, United States
  • Upper Valley Medical Center — Troy, Ohio, United States
  • Cancer Centers of Southwest Oklahoma Research — Lawton, Oklahoma, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Clackamas Radiation Oncology Center — Clackamas, Oregon, United States
  • Providence Cancer Institute Clackamas Clinic — Clackamas, Oregon, United States
  • Providence Newberg Medical Center — Newberg, Oregon, United States
  • Providence Portland Medical Center — Portland, Oregon, United States
  • Providence Saint Vincent Medical Center — Portland, Oregon, United States
  • UPMC Altoona — Altoona, Pennsylvania, United States
  • Geisinger Medical Center — Danville, Pennsylvania, United States
  • UPMC Hillman Cancer Center Erie — Erie, Pennsylvania, United States
  • UPMC Cancer Center at UPMC Horizon — Farrell, Pennsylvania, United States
  • IRMC Cancer Center — Indiana, Pennsylvania, United States
  • Geisinger Medical Oncology-Lewisburg — Lewisburg, Pennsylvania, United States
  • UPMC Hillman Cancer Center - New Castle — New Castle, Pennsylvania, United States
  • Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
  • Jefferson Torresdale Hospital — Philadelphia, Pennsylvania, United States
  • Temple University Hospital — Philadelphia, Pennsylvania, United States
  • UPMC-Saint Margaret — Pittsburgh, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC-Shadyside Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC-Passavant Hospital — Pittsburgh, Pennsylvania, United States
  • Geisinger Wyoming Valley/Henry Cancer Center — Wilkes-Barre, Pennsylvania, United States
  • UPMC Memorial — York, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Avera Cancer Institute — Sioux Falls, South Dakota, United States
  • Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
  • Avera Cancer Institute at Yankton — Yankton, South Dakota, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • Aspirus Cancer Care-Antigo-Volm Cancer Center — Antigo, Wisconsin, United States
  • ThedaCare Regional Cancer Center — Appleton, Wisconsin, United States
  • HSHS Sacred Heart Hospital — Eau Claire, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center at Saint Mary's — Green Bay, Wisconsin, United States
  • Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center — Rhinelander, Wisconsin, United States
  • Aspirus Cancer Care - Stevens Point — Stevens Point, Wisconsin, United States
  • Saint Vincent Hospital Cancer Center at Sturgeon Bay — Sturgeon Bay, Wisconsin, United States
  • Aspirus Cancer Care-Wausau — Wausau, Wisconsin, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
  • Aspirus Cancer Care - Wisconsin Rapids — Wisconsin Rapids, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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