AzTrials
AzTrials

Recurrent Head and Neck Squamous Cell CarcinomaPhase 2NCT04671667

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

A Phase 2 study testing Carboplatin, Cisplatin and Computed Tomography in people with Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 178 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 79 years
What is being tested?
Carboplatin, Cisplatin and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
178 sitesUnited States
Study dates
27 Apr 2021to 30 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 33Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

178 sites in 1 country. Contact the study team or a site near you to ask about taking part.

178 sites in 1 country

United States178 sites, 119 recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Active, not recruiting

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    Dan P. Zandberg

    Recruiting

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Aakash Batra

    Recruiting

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Suspended

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Site Public Contact, 920-364-3604, ResearchDept@thedacare.org

    Matthias Weiss

    Recruiting

  • Randolph Hospital

    Asheboro, North Carolina, 27203

    Suspended

  • Emory Proton Therapy Center

    Atlanta, Georgia, 30308

    Site Public Contact, 404-251-2854, allyson.anderson@emory.edu

    Sujith Baliga

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Sujith Baliga

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Suspended

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201

    Suspended

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Matthew J. Ferris

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Active, not recruiting

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

    Active, not recruiting

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Aakash Batra

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Active, not recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Site Public Contact, 617-636-5000, ContactUsCancerCenter@TuftsMedicalCenter.org

    Francis W. Nugent

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Suspended

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

    Active, not recruiting

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Site Public Contact, 877-668-0683, cancerclinicaltrials@med.unc.edu

    Colette Shen

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Site Public Contact, 843-792-9321, hcc-clinical-trials@musc.edu

    Jennifer L. Harper

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Jochen H. Lorch

    Recruiting

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

    Site Public Contact, 312-864-5204

    Deimante M. Tamkus

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Ameen Salahudeen

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Active, not recruiting

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

    Suspended

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

    Suspended

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Jessica L. Geiger

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

    Site Public Contact, 443-546-1300

    Matthew J. Ferris

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Active, not recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Elizabeth A. Nicolli

    Recruiting

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

    Suspended

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

    Suspended

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Active, not recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Tanmay Sahai

    Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

    Site Public Contact, 570-271-5251, cancerresearch@geisinger.edu

    Rajiv Panikkar

    Recruiting

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

    Site Public Contact, 937-276-8320

    Tarek M. Sabagh

    Recruiting

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

    Active, not recruiting

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Suspended

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Elizabeth A. Nicolli

    Recruiting

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Site Public Contact, 515-282-2200

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

    Suspended

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Active, not recruiting

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

    Active, not recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Tanmay Sahai

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Dan P. Zandberg

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

    Active, not recruiting

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

    Site Public Contact, ecog.rss@jimmy.harvard.edu

    Dan P. Zandberg

    Recruiting

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

    Active, not recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

    Active, not recruiting

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

    Site Public Contact, 410-553-8100

    Matthew J. Ferris

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Brian L. Burnette

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Brian L. Burnette

    Recruiting

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

    Site Public Contact, 937-569-7515

    Tarek M. Sabagh

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Active, not recruiting

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Dan P. Zandberg

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Active, not recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Suspended

  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

    Active, not recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Active, not recruiting

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

    Active, not recruiting

  • Kettering Medical Center

    Kettering, Ohio, 45429

    Active, not recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Active, not recruiting

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

    Active, not recruiting

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

    Site Public Contact, 877-231-4440

    Minh Phan

    Recruiting

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Active, not recruiting

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

    Site Public Contact, 570-523-9200, cancerresearch@geisinger.edu

    Rajiv Panikkar

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    Susanne M. Arnold

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Site Public Contact, 501-686-8274

    Omar T. Atiq

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Aakash Batra

    Recruiting

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

    Site Public Contact, 502-562-3429

    Neal E. Dunlap

    Recruiting

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

    Site Public Contact, 502-852-2755, ctoinfo@louisville.edu

    Neal E. Dunlap

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Tanmay Sahai

    Recruiting

  • Loyola University Medical Center

    Maywood, Illinois, 60153

    Site Public Contact, 708-226-4357

    Joseph I. Clark

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    Stuart J. Wong

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Elizabeth A. Nicolli

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Active, not recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Stuart J. Wong

    Recruiting

  • Community Medical Center

    Missoula, Montana, 59804

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Active, not recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Site Public Contact, 800-811-8480

    Jennifer H. Choe

    Recruiting

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Dan P. Zandberg

    Recruiting

  • Smilow Cancer Center/Yale-New Haven Hospital

    New Haven, Connecticut, 06510

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting

  • Mount Sinai Union Square

    New York, New York, 10003

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Richard L. Bakst

    Recruiting

  • Mount Sinai Chelsea

    New York, New York, 10011

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Richard L. Bakst

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Richard L. Bakst

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Active, not recruiting

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

    Active, not recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    Stuart J. Wong

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Minh Phan

    Recruiting

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114

    Site Public Contact, 402-334-4773

    Yungpo B. Su

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Site Public Contact, 402-354-5144

    Yungpo B. Su

    Recruiting

  • Oncology Associates PC

    Omaha, Nebraska, 68114

    Suspended

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

    Site Public Contact, 800-398-3996, clinical.trials@kp.org

    Aakash Batra

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Active, not recruiting

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

    Active, not recruiting

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

    Active, not recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Jennifer M. Johnson

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Site Public Contact, 215-728-4790

    Thomas J. Galloway

    Recruiting

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Jennifer M. Johnson

    Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

    Active, not recruiting

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

    Site Public Contact, 412-784-4900

    Dan P. Zandberg

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Dan P. Zandberg

    Recruiting

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

    Active, not recruiting

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

    Site Public Contact, 412-367-6454

    Dan P. Zandberg

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Elizabeth A. Nicolli

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Alison K. Conlin

    Recruiting

  • Annie Penn Memorial Hospital

    Reidsville, North Carolina, 27320

    Site Public Contact, 336-832-0836, stacey.phelps@conehealth.com

    Vinay K. Gudena

    Recruiting

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Reid Health

    Richmond, Indiana, 47374

    Active, not recruiting

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

    Site Public Contact, ctoclinops@vcu.edu

    Erin R. Alesi

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Erin R. Alesi

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    Monaliben Patel

    Recruiting

  • Sutter Cancer Centers Radiation Oncology Services-Roseville

    Roseville, California, 95661

    Active, not recruiting

  • Sutter Roseville Medical Center

    Roseville, California, 95661

    Active, not recruiting

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

    Active, not recruiting

  • California Protons Cancer Therapy Center

    San Diego, California, 92121

    Active, not recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

    Suspended

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

    Site Public Contact, 605-322-3095, OncRegulatory@avera.org

    Benjamin M. Solomon

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Daniel Almquist

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

    Suspended

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Active, not recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Active, not recruiting

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

    Active, not recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Site Public Contact, 800-862-2215

    Amna Sher

    Recruiting

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Brian L. Burnette

    Recruiting

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Kedar Kirtane

    Recruiting

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Kedar Kirtane

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Kedar Kirtane

    Recruiting

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Rafi Kabarriti

    Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Rafi Kabarriti

    Recruiting

  • Upper Valley Medical Center

    Troy, Ohio, 45373

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Tarek M. Sabagh

    Recruiting

  • Smilow Cancer Hospital Care Center-Trumbull

    Trumbull, Connecticut, 06611

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Active, not recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Tanmay Sahai

    Recruiting

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

    Suspended

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Jochen H. Lorch

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Site Public Contact, 202-877-8839

    Cristina Merkhofer

    Recruiting

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385

    Site Public Contact, 203-785-5702, canceranswers@yale.edu

    Aarti Bhatia

    Recruiting

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Site Public Contact, 515-241-3305

    Seema Harichand-Herdt

    Recruiting

  • Aspirus Cancer Care-Wausau

    Wausau, Wisconsin, 54401

    Site Public Contact, 877-405-6866

    Andrew J. Huang

    Recruiting

  • Wilmot Cancer Institute at Webster

    Webster, New York, 14580

    Site Public Contact, WCICTOresearch@urmc.rochester.edu

    Monaliben Patel

    Recruiting

  • Moffitt Cancer Center at Wesley Chapel

    Wesley Chapel, Florida, 33544

    Site Public Contact, 800-679-0775, ClinicalTrials@moffitt.org

    Kedar Kirtane

    Recruiting

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

    Site Public Contact, 414-805-0505

    Stuart J. Wong

    Recruiting

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

    Suspended

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Active, not recruiting

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

    Site Public Contact, 570-271-5251, HemonCCTrials@geisinger.edu

    Rajiv Panikkar

    Recruiting

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

    Site Public Contact, 715-422-7718

    Andrew J. Huang

    Recruiting

  • Avera Cancer Institute at Yankton

    Yankton, South Dakota, 57078

    Site Public Contact, 605-655-1800, OncRegulatory@avera.org

    Benjamin M. Solomon

    Recruiting

  • UPMC Memorial

    York, Pennsylvania, 17408

    Site Public Contact, 717-724-6760

    Dan P. Zandberg

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate overall survival (OS) of adjuvant pembrolizumab for 12 months compared to adjuvant reirradiation plus concurrent platinum chemotherapy in high risk head and neck squamous cell carcinoma (HNSCC) patients.

SECONDARY OBJECTIVES:

  1. To evaluate the following endpoints in both arms: disease free survival (DFS), locoregional control, rates of distant metastasis, toxicity.

II. To evaluate whether high PD-L1 expression (defined as Combined Positive Score [CPS] >= 20) is predictive of increased efficacy in the experimental group compared to control.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM B: Patients receive cisplatin or carboplatin intravenously (IV) on day 1. Treatment repeats every 7 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy (PBRT) once daily (QD) for a total of 30 fractions in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity.

Patients in all arms undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial.

After completion of study treatment, patients are followed up at 30 days, and then every 6 months for up to 5 years from the date of registration.

Being tested
Carboplatin, Cisplatin, Computed Tomography, Intensity-Modulated Radiation Therapy, Magnetic Resonance Imaging
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

  • Proton Beam Radiation TherapyRadiation

    Also called External beam radiation therapy protons (procedure), External Beam Radiotherapy (protons), PBRT, Proton

    Undergo PBRT

Study groups in NCT04671667
Study groupRoleWhat they receive
Arm B (cisplatin, carboplatin, IMRT, PBRT)Active comparatorPatients receive cisplatin or carboplatin IV on day 1. Treatment repeats every 7 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo IMRT or PBRT QD for a total of 30 fractions in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial.
Receives: Drug: Carboplatin; Drug: Cisplatin; Procedure: Computed Tomography; Radiation: Intensity-Modulated Radiation Therapy; Procedure: Magnetic Resonance Imaging; Radiation: Proton Beam Radiation Therapy
Arm C (pembrolizumab)ExperimentalPatients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial.
Receives: Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Kaplan-Meier estimates will be used to estimate the OS distributions. A log-rank test with one-sided 10% type I error will be used for the comparison.

    Measured: From randomization to date of death from any cause, measured at 2 years

  2. Incidence of adverse events

    Assessed using Common Terminology Criteria for Adverse Events. An 80% confidence interval around the hazard ratio of the two experimental arms will be calculated. Toxicity will be compared between the two treatment arms. Toxicity will be examined by arm and compared using the Fisher's exact test.

    Measured: Up to 5 years from date of registration

Secondary outcomes (2)

  1. Disease free survival

    Measured: From the date of randomization to the date of recurrence, second primary tumor from the head and neck region, or death, assessed up to 5 years from date of registration

  2. PD-L1 expression

    Defined as Combined Positive Score >= 20 as a predictive marker of efficacy.

    Measured: Up to 5 years from date of registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start27 Apr 2021
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04671667
Sponsor's protocol ID
NCI-2020-13174
Other IDs
NCI-2020-13174, EA3191, EA3191, U10CA180820
Status last verified
Sep 2026
First submitted
16 Dec 2020
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Cisplatin and Computed Tomography in people with Recurrent Head and Neck Squamous Cell Carcinoma and Recurrent Hypopharyngeal Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 178 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From randomization to date of death from any cause, measured at 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04671667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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