Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 79 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 defined as anyone, regardless of
sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has achieved menarche at some point, 2) has not undergone a
hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal
(amenorrhea following cancer therapy does not rule out childbearing potential) for
at least 24 consecutive months (i.e., has had menses at any time in the preceding 24
consecutive months)

- Patient must not expect to conceive or father children by using by using accepted
and effective method(s) of contraception or by abstaining from sexual intercourse
while on study treatment, and continue for 120 days after the last dose of study
treatment

- Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 28 days prior to protocol
randomization)

- Platelets >= 100,000/mcL (obtained =< 28 days prior to protocol randomization)

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained =< 28
days prior to protocol randomization)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT])
=< 3.0 x institutional ULN (obtained =< 28 days prior to protocol randomization)

- Creatinine clearance > 30 ml/min using the Cockcroft-Gault formula (obtained =< 28
days prior to protocol randomization)

- Patient must not have a current active infection that requires systemic treatment at
time of randomization

- Patient must not have a history of non-infectious pneumonitis requiring steroids
within 3 years prior to randomization

- Patient must not have a history of solid organ transplant or stem cell transplant

- Patient must not be on immunosuppressive medication within 7 days prior to
randomization, EXCEPT for the following: a) intranasal, inhaled, topical steroids,
or local steroid injection (e.g., intra-articular injection); b) systemic
corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent; c)
steroids as premedication for hypersensitivity reactions (e.g., CT scan
premedication)

- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional classification. Patients
with New York Heart Association class III or IV heart failure are not eligible

- Patient must not have received a live vaccine within 30 days prior to the first dose
of study drug. Examples of live vaccines include, but are not limited to, the
following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever,
rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza
vaccines for injection are generally killed virus vaccines and are allowed; however,
intranasal influenza vaccines (e.g., FluMist [registered trademark]) are live
attenuated vaccines and are not allowed

- Patient must not have severe hypersensitivity (>= grade 3) to pembrolizumab and/or
any of its excipients

- Patient must not have an active autoimmune disease that has required systemic
treatment in past 2 years (i.e., with use of disease modifying agents,
corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine,
insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary
insufficiency) is not considered a form of systemic treatment and is allowed

- Patient must not have a known psychiatric or substance abuse disorder that would
interfere with the participant's ability to cooperate with the requirements of the
study

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial as
long as they have not been HIV-infected with a history of Kaposi sarcoma and/or
multicentric Castleman disease

- Patient must not have a known history of hepatitis B (defined as hepatitis B surface
antigen [HBsAg] reactive) or known active hepatitis C virus (defined as HCV
ribonucleic acid [RNA] [qualitative] is detected) infection

- NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by
a local health authority

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm B (cisplatin, carboplatin, IMRT, PBRT)
Patients 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.
  • Drug: Carboplatin
    Given IV
    Other names:
    • Blastocarb
    • Carboplat
    • Carboplatin Hexal
    • Carboplatino
    • Carboplatinum
    • Carbosin
    • Carbosol
    • Carbotec
    • CBDCA
    • Displata
    • Ercar
    • JM-8
    • JM8
    • Nealorin
    • Novoplatinum
    • Paraplatin
    • Paraplatin AQ
    • Paraplatine
    • Platinwas
    • Ribocarbo
  • Drug: Cisplatin
    Given IV
    Other names:
    • Abiplatin
    • Blastolem
    • Briplatin
    • CDDP
    • Cis-diammine-dichloroplatinum
    • Cis-diamminedichloridoplatinum
    • Cis-diamminedichloro Platinum (II)
    • Cis-diamminedichloroplatinum
    • Cis-dichloroammine Platinum (II)
    • Cis-platinous Diamine Dichloride
    • Cis-platinum
    • Cis-platinum II
    • Cis-platinum II Diamine Dichloride
    • Cismaplat
    • Cisplatina
    • Cisplatinum
    • Cisplatyl
    • Citoplatino
    • Citosin
    • Cysplatyna
    • DDP
    • Lederplatin
    • Metaplatin
    • Neoplatin
    • Peyrone's Chloride
    • Peyrone's Salt
    • Placis
    • Plastistil
    • Platamine
    • Platiblastin
    • Platiblastin-S
    • Platinex
    • Platinol
    • Platinol- AQ
    • Platinol-AQ
    • Platinol-AQ VHA Plus
    • Platinoxan
    • Platinum
    • Platinum Diamminodichloride
    • Platiran
    • Platistin
    • Platosin
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other names:
    • IMRT
    • Intensity modulated radiation therapy (procedure)
    • Intensity Modulated RT
    • Intensity-Modulated Radiotherapy
    • Radiation, Intensity-Modulated Radiotherapy
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Radiation: Proton Beam Radiation Therapy
    Undergo PBRT
    Other names:
    • External beam radiation therapy protons (procedure)
    • External Beam Radiotherapy (protons)
    • PBRT
    • Proton
    • Proton EBRT
    • Proton External Beam Radiotherapy
    • Proton Radiation Therapy
    • PROTON Therapy
    • Radiation, Proton Beam
Experimental
Arm C (pembrolizumab)
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 also undergo CT or MRI throughout the trial.
  • Procedure: Computed Tomography
    Undergo CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other names:
    • Magnetic Resonance
    • Magnetic Resonance Imaging (MRI)
    • Magnetic resonance imaging (procedure)
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR
    • MR Imaging
    • MRI
    • MRI Scan
    • MRIs
    • NMR Imaging
    • NMRI
    • Nuclear Magnetic Resonance Imaging
    • sMRI
    • Structural MRI
  • Biological: Pembrolizumab
    Given IV
    Other names:
    • BCD-201
    • GME 751
    • GME751
    • Keytruda
    • Lambrolizumab
    • MK 3475
    • MK-3475
    • MK3475
    • Pembrolizumab Biosimilar BCD-201
    • Pembrolizumab Biosimilar GME751
    • Pembrolizumab Biosimilar QL2107
    • QL2107
    • SCH 900475
    • SCH-900475
    • SCH900475

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut 06510
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Yale University
New Haven, Connecticut 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Site Public Contact
202-877-8839

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
Contact:
Site Public Contact
305-243-2647

Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Emory Proton Therapy Center
Atlanta, Georgia 30308
Contact:
Site Public Contact
404-251-2854
allyson.anderson@emory.edu

Emory University Hospital Midtown
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612
Contact:
Site Public Contact
312-864-5204

Carle at The Riverfront
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Reid Health
Richmond, Indiana 47374
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-282-2921

Heartland Oncology and Hematology LLP
Council Bluffs, Iowa 51503
Contact:
Site Public Contact
712-322-4136

Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa 51503
Contact:
Site Public Contact
402-354-7939
kathryn.bartz@nmhs.org

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

Mission Cancer and Blood - Des Moines
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305

Broadlawns Medical Center
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200

University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300

UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Site Public Contact
617-636-5000
ContactUsCancerCenter@TuftsMedicalCenter.org

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Site Public Contact
601-815-6700

Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula, Montana 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-334-4773

Nebraska Methodist Hospital
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5144

Oncology Associates PC
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5860
info@oa-oc.com

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Mount Sinai Union Square
New York, New York 10003
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Mount Sinai Chelsea
New York, New York 10011
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Mount Sinai Hospital
New York, New York 10029
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Stony Brook University Medical Center
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215

Cone Health Cancer Center
Greensboro, North Carolina 27403
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Annie Penn Memorial Hospital
Reidsville, North Carolina 27320
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Premier Blood and Cancer Center
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320

Dayton Physician LLC - Englewood
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515

Greater Dayton Cancer Center
Kettering, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
Contact:
Site Public Contact
877-231-4440

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

UPMC Altoona
Altoona, Pennsylvania 16601
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
Contact:
Site Public Contact
215-728-4790

Jefferson Torresdale Hospital
Philadelphia, Pennsylvania 19114
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073

UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

UPMC Memorial
York, Pennsylvania 17408
Contact:
Site Public Contact
717-724-6760

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Avera Cancer Institute
Sioux Falls, South Dakota 57105
Contact:
Site Public Contact
605-322-3095
OncRegulatory@avera.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
CTOclinops@vcu.edu

ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Contact:
Site Public Contact
920-364-3604
ResearchDept@thedacare.org

HSHS Sacred Heart Hospital
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

More Details

NCT ID
NCT04671667
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVE: I. 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: I. 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.

Notice

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