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

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

  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Hypopharyngeal Squamous Cell Carcinoma
  • Recurrent Laryngeal Squamous Cell Carcinoma
  • Recurrent Oral Cavity Squamous Cell Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma

Eligibility

Eligible Ages
Between 18 Years and 79 Years
Eligible Sex
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 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

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
    • Pembrolizumab Biosimilar RPH-075
    • Pembrolizumab Biosimilar SB27
    • QL2107
    • RPH 075
    • RPH-075
    • RPH075
    • SB 27
    • SB-27
    • SB27
    • SCH 900475
    • SCH-900475
    • SCH900475

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Site Public Contact
501-686-8274

Kaiser Permanente-Anaheim
Anaheim 5323810, California 5332921 92806
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Bellflower
Bellflower 5327422, California 5332921 90706
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine 5359777, California 5332921 92612
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

Kaiser Permanente Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90027
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Ontario
Ontario 5379439, California 5332921 91761
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange 5379513, California 5332921 92868
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

California Protons Cancer Therapy Center
San Diego 5391811, California 5332921 92121
Contact:
Site Public Contact
858-299-5982

Smilow Cancer Center/Yale-New Haven Hospital
New Haven 4839366, Connecticut 4831725 06510
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Yale University
New Haven 4839366, Connecticut 4831725 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center-Trumbull
Trumbull 4844459, Connecticut 4831725 06611
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

Smilow Cancer Hospital Care Center - Waterford
Waterford 8480031, Connecticut 4831725 06385
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables 4151871, Florida 4155751 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach 4153071, Florida 4155751 33442
Contact:
Site Public Contact
305-243-2647

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami 4164138, Florida 4155751 33136
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Plantation
Plantation 4168782, Florida 4155751 33324
Contact:
Site Public Contact
305-243-2647

Moffitt Cancer Center - McKinley Campus
Tampa 4174757, Florida 4155751 33612
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Contact:
Site Public Contact
800-679-0775
ClinicalTrials@moffitt.org

Emory Proton Therapy Center
Atlanta 4180439, Georgia 4197000 30308
Contact:
Site Public Contact
404-251-2854
allyson.anderson@emory.edu

Emory University Hospital Midtown
Atlanta 4180439, Georgia 4197000 30308
Contact:
Site Public Contact
888-946-7447

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

John H Stroger Jr Hospital of Cook County
Chicago 4887398, Illinois 4896861 60612
Contact:
Site Public Contact
312-864-5204

University of Illinois
Chicago 4887398, Illinois 4896861 60612
Contact:
Site Public Contact
312-355-3046

Carle at The Riverfront
Danville 4889426, Illinois 4896861 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Decatur Memorial Hospital
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Kishwaukee
DeKalb 4889553, Illinois 4896861 60115
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Effingham
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern Medicine Cancer Center Delnor
Geneva 4893591, Illinois 4896861 60134
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

Carle Physician Group-Mattoon/Charleston
Mattoon 4244099, Illinois 4896861 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Loyola University Medical Center
Maywood 4901514, Illinois 4896861 60153
Contact:
Site Public Contact
708-226-4357

HSHS Saint Elizabeth's Hospital
O'Fallon 4245926, Illinois 4896861 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
800-444-7541

Springfield Memorial Hospital
Springfield 4250542, Illinois 4896861 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Northwestern Medicine Cancer Center Warrenville
Warrenville 4915525, Illinois 4896861 60555
Contact:
Site Public Contact
630-352-5360
Donald.Smith3@nm.org

UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny 4846960, Iowa 4862182 50023
Contact:
Site Public Contact
515-241-3305

Heartland Oncology and Hematology LLP
Council Bluffs 4852832, Iowa 4862182 51503
Contact:
Site Public Contact
712-322-4136

Methodist Jennie Edmundson Hospital
Council Bluffs 4852832, Iowa 4862182 51503
Contact:
Site Public Contact
402-354-7939
kathryn.bartz@nmhs.org

Iowa Methodist Medical Center
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-6727

UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-3305

Broadlawns Medical Center
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-282-2200

UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee 4880981, Iowa 4862182 50263
Contact:
Site Public Contact
515-241-3305

University of Kentucky/Markey Cancer Center
Lexington 4297983, Kentucky 6254925 40536
Contact:
Site Public Contact
859-257-3379

The James Graham Brown Cancer Center at University of Louisville
Louisville 4299276, Kentucky 6254925 40202
Contact:
Site Public Contact
502-562-3429

UofL Health Medical Center Northeast
Louisville 4299276, Kentucky 6254925 40245
Contact:
Site Public Contact
502-852-2755
ctoinfo@louisville.edu

University of Maryland/Greenebaum Cancer Center
Baltimore 4347778, Maryland 4361885 21201
Contact:
Site Public Contact
800-888-8823

Central Maryland Radiation Oncology in Howard County
Columbia 4352053, Maryland 4361885 21044
Contact:
Site Public Contact
443-546-1300

UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie 4356188, Maryland 4361885 21061
Contact:
Site Public Contact
410-553-8100

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Contact:
Site Public Contact
617-636-5000
ContactUsCancerCenter@TuftsMedicalCenter.org

Sanford Joe Lueken Cancer Center
Bemidji 5017822, Minnesota 5037779 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
Contact:
Site Public Contact
601-815-6700

Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066

Benefis Sletten Cancer Institute
Great Falls 5655240, Montana 5667009 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Logan Health Medical Center
Kalispell 5660340, Montana 5667009 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula 5666639, Montana 5667009 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
Omaha 5074472, Nebraska 5073708 68114
Contact:
Site Public Contact
402-334-4773

Nebraska Methodist Hospital
Omaha 5074472, Nebraska 5073708 68114
Contact:
Site Public Contact
402-354-5144

University of New Mexico Cancer Center
Albuquerque 5454711, New Mexico 5481136 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Mount Sinai Union Square
New York 5128581, New York 5128638 10003
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Mount Sinai Chelsea
New York 5128581, New York 5128638 10011
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Mount Sinai Hospital
New York 5128581, New York 5128638 10029
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

University of Rochester
Rochester 5134086, New York 5128638 14642
Contact:
Site Public Contact
585-275-5830

Stony Brook University Medical Center
Stony Brook 5139865, New York 5128638 11794
Contact:
Site Public Contact
800-862-2215

Montefiore Medical Center-Einstein Campus
The Bronx 5110266, New York 5128638 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center - Moses Campus
The Bronx 5110266, New York 5128638 10467
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Wilmot Cancer Institute at Webster
Webster 5143495, New York 5128638 14580
Contact:
Site Public Contact
WCICTOresearch@urmc.rochester.edu

Cone Health Cancer Center
Greensboro 4469146, North Carolina 4482348 27403
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Annie Penn Memorial Hospital
Reidsville 4487682, North Carolina 4482348 27320
Contact:
Site Public Contact
336-832-0836
stacey.phelps@conehealth.com

Sanford Bismarck Medical Center
Bismarck 5688025, North Dakota 5690763 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo 5059163, North Dakota 5690763 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Miami Valley Hospital South
Centerville 4508204, Ohio 5165418 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Premier Blood and Cancer Center
Dayton 4509884, Ohio 5165418 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital North
Dayton 4509884, Ohio 5165418 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin 4512203, Ohio 5165418 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville 5156493, Ohio 5165418 45331
Contact:
Site Public Contact
937-569-7515

Upper Valley Medical Center
Troy 5174358, Ohio 5165418 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Cancer Centers of Southwest Oklahoma Research
Lawton 4540737, Oklahoma 4544379 73505
Contact:
Site Public Contact
877-231-4440

University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Providence Newberg Medical Center
Newberg 5742726, Oregon 5744337 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland 5746545, Oregon 5744337 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

UPMC Altoona
Altoona 5178195, Pennsylvania 6254927 16601
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

UPMC Hillman Cancer Center Erie
Erie 5188843, Pennsylvania 6254927 16505
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Cancer Center at UPMC Horizon
Farrell 5189377, Pennsylvania 6254927 16121
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Geisinger Medical Oncology-Lewisburg
Lewisburg 5197842, Pennsylvania 6254927 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

UPMC Hillman Cancer Center - New Castle
New Castle 5203127, Pennsylvania 6254927 16105
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111
Contact:
Site Public Contact
215-728-4790

Jefferson Torresdale Hospital
Philadelphia 4560349, Pennsylvania 6254927 19114
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

UPMC-Saint Margaret
Pittsburgh 5206379, Pennsylvania 6254927 15215
Contact:
Site Public Contact
412-784-4900

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh 5206379, Pennsylvania 6254927 15232
Contact:
Site Public Contact
412-647-8073

UPMC-Passavant Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15237
Contact:
Site Public Contact
412-367-6454

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

UPMC Memorial
York 4562407, Pennsylvania 6254927 17408
Contact:
Site Public Contact
717-724-6760

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Site Public Contact
843-792-9321
hcc-clinical-trials@musc.edu

Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105
Contact:
Site Public Contact
605-322-3095
OncRegulatory@avera.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Avera Cancer Institute at Yankton
Yankton 5233053, South Dakota 5769223 57078
Contact:
Site Public Contact
605-322-3095
OncRegulatory@avera.org

Vanderbilt University/Ingram Cancer Center
Nashville 4644585, Tennessee 4662168 37232
Contact:
Site Public Contact
800-811-8480

VCU Massey Cancer Center at Stony Point
Richmond 4781708, Virginia 6254928 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

VCU Massey Comprehensive Cancer Center
Richmond 4781708, Virginia 6254928 23298
Contact:
Site Public Contact
804-628-6430
CTOclinops@vcu.edu

ThedaCare Regional Cancer Center
Appleton 5244080, Wisconsin 5279468 54911
Contact:
Site Public Contact
920-364-3604
ResearchDept@thedacare.org

Saint Vincent Hospital Cancer Center Green Bay
Green Bay 5254962, Wisconsin 5279468 54301
Contact:
Site Public Contact
920-433-8889
WI_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay 5254962, Wisconsin 5279468 54303
Contact:
Site Public Contact
920-433-8889
wi_research_admin@hshs.org

Froedtert Menomonee Falls Hospital
Menomonee Falls 5262630, Wisconsin 5279468 53051
Contact:
Site Public Contact
262-257-5100

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Site Public Contact
414-805-3666

Drexel Town Square Health Center
Oak Creek 5265228, Wisconsin 5279468 53154
Contact:
Site Public Contact
414-805-0505

Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Contact:
Site Public Contact
920-433-8889
wi_research_admin@hshs.org

Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend 5278422, Wisconsin 5279468 53095
Contact:
Site Public Contact
414-805-0505

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.