Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:April 5, 2017
End Date:June 29, 2023
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)

The purpose of this study is to determine the efficacy and safety of pembrolizumab given
concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in
participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The
primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in
combination with CRT with respect to event-free survival (EFS) per Response Evaluation
Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).


Inclusion Criteria:

- Has a pathologically proven new diagnosis of oropharyngeal p16 positive, oropharyngeal
p16 negative, or larynx/hypopharynx/oral cavity (independent of p16) squamous cell
carcinoma. Participants with oral cavity tumors need to have unresectable disease.
Participants with multiple synchronous tumors are not eligible for the study.

- Has provided tissue for Programmed Cell Death Receptor Ligand 1 (PD-L1) biomarker
analysis from a core or excisional biopsy. If an excisional or incisional biopsy has
been performed, participants remain eligible for the study provided the residual
disease meets the staging criteria required for the trial (e.g., excisional biopsy of
a lymph node with residual T4 primary). Prior surgical debulking, including
tonsillectomy, for the head and neck cancer under study is not allowed.

- Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed
by computed tomography scan or magnetic resonance imaging, based on RECIST version 1.1

- Is eligible for definitive CRT and not considered for primary surgery based on
investigator decision

- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed
within 10 days prior to receiving the first dose of study therapy

- Female participants of childbearing potential must have a negative urine or serum
pregnancy test within 72 hours prior to receiving the first dose of study therapy

- Female and male participants of reproductive potential must agree to use adequate
contraception throughout the study period and for up to 180 days after the last dose
of study therapy

Exclusion Criteria:

- Is currently participating or has participated in a study with an investigational
agent or using an investigational device within 4 weeks of the first dose of study
therapy

- Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1),
anti-PD-L1, anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an
agent directed to another co-inhibitory T-cell receptor or has previously participated
in clinical studies with pembrolizumab

- Has received a live vaccine within 30 days prior to the first dose of study therapy

- Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as
nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer

- Has had prior systemic therapy, targeted therapy, radiotherapy treatment or radical
surgery for head and neck cancer under study

- Has not recovered from major surgery prior to starting study therapy

- Has known active Hepatitis B or C

- Has known history of Human Immunodeficiency Virus (HIV)

- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of study
therapy

- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis

- Has an active autoimmune disease that has required systemic treatment in the past 2
years. Replacement therapy is not considered a form of systemic treatment.

- Has history of a diagnosed and/or treated hematologic or primary solid tumor
malignancy, unless in remission for at least 5 years prior to randomization

- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis

- Has had previous allogeneic tissue/solid organ transplant

- Has active infection requiring systemic therapy

- Has a history of severe hypersensitivity reaction to pembrolizumab, Cisplatin or
radiotherapy or their analogs

- Is pregnant or breast feeding or expecting to conceive or father children throughout
the study period and for up to 180 days after the last dose of study therapy
We found this trial at
24
sites
1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Phone: 434-244-4673
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Phone: 313-576-8994
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 317-278-0779
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Ann Arbor, Michigan 48109
Phone: 734-936-5281
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Arlington, Texas 76012
Phone: 281-863-6660
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Austin, Texas 78731
Phone: 281-863-6685
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Baton Rouge, Louisiana 70809
Phone: 225-215-1129
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Billings, Montana 59102
Phone: 406-238-6290
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Phone: 312-942-8004
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Phone: 281-863-6685
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Easton, Pennsylvania 18045
Phone: 484-503-4156
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Eugene, Oregon 97401
Phone: 281-863-6685
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Greenville, South Carolina 29607
Phone: 864-603-6214
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Phone: 702-952-1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Longview, Texas 75601
Phone: 281-863-6685
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Phone: 310-794-6500
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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New Haven, Connecticut 06520
Phone: 203-737-7981
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Rochester, New York 14642
Phone: 585-275-5823
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San Francisco, California 94143
Phone: 415-502-3081
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Santa Rosa, California 95403
Phone: 707-521-3830
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Seattle, Washington 98109
Phone: 206-288-2048
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6001 North Mayfair Street
Spokane, Washington 99208
Phone: 509-462-2273
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2055 South Fremont Avenue
Springfield, Missouri 65804
Phone: 417-820-8099
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Worcester, Massachusetts 01655
Phone: 508-856-3216
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