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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)

Primary Purpose

Head and Neck Neoplasms

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Pembrolizumab

Placebo

Cisplatin

Accelerated Fractionation (AFX) Radiotherapy

Standard Fractionation (SFX) Radiotherapy

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Head and Neck Squamous Cell Carcinoma, Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (PD-L1), Programmed Cell Death Receptor Ligand 2 (PD-L2), PD1, PD-1, PDL1, PD-L1, PDL2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UCLA Medical Center ( Site 0273)
University of California San Francisco ( Site 0274)
St. Joseph Heritage Healthcare ( Site 0254)
Smilow Cancer Hospital at Yale New Haven ( Site 0256)
Rush University Medical Center ( Site 0260)
Indiana University ( Site 0264)
Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281)
University of Massachusetts Memorial Medical Center ( Site 0285)
University of Michigan Hospital and Health Systems ( Site 0267)
Barbara Ann Karmanos Cancer Institute ( Site 0272)
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290)
St. Vincent Healthcare Frontier Cancer Center ( Site 0286)
Comprehensive Cancer Centers of Nevada ( Site 8004)
University of Rochester - James P. Wilmot Cancer Center ( Site 0255)
Oncology Hematology Care, Inc. ( Site 8003)
Willamette Valley Cancer Institute and Research Center ( Site 8000)
St. Luke's Cancer Center - Anderson ( Site 0251)
St. Francis Hospital Cancer Center ( Site 1461)
Texas Oncology-Arlington North ( Site 8005)
Texas Oncology-Austin Central ( Site 8002)
Texas Oncology PA ( Site 8001)
University of Virginia Health System ( Site 0261)
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269)
Medical Oncology Associates (Summit Cancer Centers) ( Site 0257)
Liverpool Hospital ( Site 0301)
Blacktown Hospital Western Sydney Local Health District ( Site 0304)
Princess Alexandra Hospital ( Site 0305)
Royal Brisbane and Women s Hospital ( Site 0302)
Royal Adelaide Hospital ( Site 0303)
Peter MacCallum Cancer Centre ( Site 0300)
Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601)
Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603)
Landeskrankenhaus Salzburg ( Site 0600)
Allgemeines Krankenhaus der Stadt Wien ( Site 0602)
Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651)
UZ Gent ( Site 0650)
UZ Leuven Campus Gasthuisberg ( Site 0652)
C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654)
Clinique et Maternite Sainte-Elisabeth ( Site 0653)
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006)
Centro Regional Integrado de Oncologia ( Site 0002)
Liga Norte Riograndense Contra o Cancer ( Site 0005)
Hospital Nossa Senhora da Conceicao ( Site 0001)
Hospital de Clinicas de Porto Alegre ( Site 0011)
Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003)
Instituto do Cancer de Sao Paulo - ICESP ( Site 0004)
Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008)
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010)
Tom Baker Cancer Centre ( Site 0063)
Cross Cancer Institute ( Site 0064)
Juravinski Cancer Centre ( Site 0062)
London Health Sciences Centre ( Site 0055)
The Ottawa Hospital - Cancer Care ( Site 0052)
Princess Margaret Cancer Centre ( Site 0051)
McGill University Health Centre ( Site 0061)
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057)
Hospital Pablo Tobon Uribe ( Site 0151)
Fundacion Valle del Lili ( Site 0150)
Centro Medico Imbanaco de Cali S.A ( Site 0156)
Centro de Investigacion Clinica del Country ( Site 0155)
FN Brno. ( Site 0703)
Fakultni Nemocnice Hradec Kralove ( Site 0705)
Fakultni nemocnice Olomouc ( Site 0701)
Fakultni nemocnice Ostrava ( Site 0702)
Nemocnice Na Bulovce ( Site 0700)
2. LF UK a FN Motol ( Site 0704)
Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760)
Clinique Francois Chenieux ( Site 0757)
Institut Claudius Regaud ( Site 0754)
Institut De Cancerologie De Lorraine ( Site 0758)
Institut Gustave Roussy ( Site 0759)
Universitätsklinikum Erlangen ( Site 0801)
SRH Waldklinikum Gera GmbH ( Site 0802)
Universitares Cancer Center Hamburg - UCCH ( Site 0811)
Medizinische Hochschule Hannover ( Site 0807)
Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803)
Klinikum der Universitaet Munchen ( Site 0810)
Universitaetsklinik Ulm ( Site 0804)
Rambam MC ( Site 0903)
Hadassah Ein Karem Jerusalem ( Site 0902)
Rabin Medical Center ( Site 0904)
Sheba MC ( Site 0901)
Tel Aviv Sourasky Medical Center ( Site 0900)
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954)
Azienda Ospedaliero Universitaria Careggi ( Site 0955)
Istituto Nazionale Tumori ( Site 0950)
Istituto Europeo di Oncologia ( Site 0953)
Azienda Ospedaliera San Paolo ( Site 0952)
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951)
Istituto Oncologico Veneto ( Site 0957)
Fondazione IRCCS - Policlinico San Matteo ( Site 0960)
National Cancer Center Hospital East ( Site 0350)
Hokkaido University Hospital ( Site 0351)
Hyogo Cancer Center ( Site 0354)
Kagawa University Hospital ( Site 0359)
Miyagi Cancer Center ( Site 0353)
Chiba Cancer Center ( Site 0358)
Hiroshima University Hospital ( Site 0352)
Osaka International Cancer Institute ( Site 0355)
Medical Hospital, Tokyo Medical And Dental University ( Site 0356)
The Cancer Institute Hospital of JFCR ( Site 0357)
Chungbuk National University Hospital ( Site 0454)
Seoul National University Bundang Hospital ( Site 0453)
Chungnam National University Hospital ( Site 0455)
Severance Hospital Yonsei University Health System ( Site 0452)
Samsung Medical Center ( Site 0450)
Noordwest Ziekenhuisgroep NWZ ( Site 1350)
VU Medisch Centrum ( Site 1352)
UMCG ( Site 1351)
UMC St. Radboud ( Site 1356)
Erasmus University Medical Center ( Site 1354)
Capital & Coast District Health Board - Wellington Hospital ( Site 0400)
Dolnoslaskie Centrum Onkologii. ( Site 1001)
Mazowiecki Szpital Onkologiczny ( Site 1015)
Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005)
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007)
Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010)
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008)
Zachodniopomorskie Centrum Onkologii ( Site 1013)
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000)
H.U. Vall de Hebron ( Site 1052)
Hospital Duran i Reynals ( Site 1053)
Hospital Doce de Octubre ( Site 1054)
Hospital Universitario Ramon y Cajal ( Site 1055)
Hospital Clinico San Carlos ( Site 1051)
Hospital Universitario Virgen de la Victoria ( Site 1056)
Hospital Gral Universitario de Valencia ( Site 1050)
Chang Gung Medical Foundation - Kaohsiung ( Site 0501)
Taichung Veterans General Hospital ( Site 0506)
National Cheng Kung University Hospital ( Site 0503)
National Taiwan University Hospital ( Site 0500)
MacKay Memorial Hospital ( Site 0505)
Taipei Veterans General Hospital ( Site 0504)
Linkou Chang Gung Memorial Hospital ( Site 0502)
Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102)
Ankara Sehir Hastanesi ( Site 1108)
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100)
Medipol Universite Hastanesi ( Site 1104)
Medical Park Izmir Hastanesi ( Site 1109)
Kocaeli Universitesi Tip Fakultesi ( Site 1106)
Inonu Universitesi Tip Fakultesi ( Site 1101)
Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206)
University Hospital of North Staffordshire ( Site 1202)
Ipswich Hospital ( Site 1207)
St Bartholomew s Hospital ( Site 1205)
The Royal Marsden Foundation Trust ( Site 1200)
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204)
Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208)
University Hospital Southampton NHS Foundation Trust ( Site 1203)
Royal Marsden NHS Foundation Trust ( Site 1201)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab + Cisplatin + CRT

Placebo + Cisplatin + CRT

Arm Description

Participants receive a priming dose of pembrolizumab before initiation of CRT (either accelerated or standard fractionation radiotherapy regimen). During CRT, participants receive 2 doses of pembrolizumab and up to 3 cycles of Cisplatin (2 cycles during accelerated and 3 cycles during standard fractionation radiotherapy). Participants also receive up to an additional 14 cycles of pembrolizumab alone as maintenance therapy for a total of 17 cycles of pembrolizumab. If cisplatin and/or radiation therapy is discontinued, the participant may continue on treatment with pembrolizumab.

Participants receive placebo before initiation of CRT (either accelerated or standard fractionation radiotherapy regimen). During CRT, participants receive 2 doses of placebo and up to 3 cycles of Cisplatin (2 cycles during accelerated and 3 cycles during standard fractionation radiotherapy). Participants also receive up to an additional 14 cycles of placebo alone for a total of 17 cycles of placebo. If cisplatin and/or radiation therapy is discontinued, the participant may continue on treatment with placebo.

Outcomes

Primary Outcome Measures

Event-free Survival (EFS)

EFS is the time from date of randomization to the date of first record of any of the following events: death due to any cause; progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR) or biopsy as indicated for locoregional progression or recurrence or distant metastasis. As well as the first record of the following types of surgery: salvage surgery for persistent or residual disease at the primary tumor site requiring surgical removal when invasive cancer is present on final pathology; neck dissection or surgery (performed for clinical or radiological disease progression per RECIST 1.1) ≤ 20 weeks from end of CRT when invasive cancer is present; or neck dissection or surgery >20 weeks from end of CRT when invasive cancer is present. From product-limit (Kaplan-Meier) method for censored data.

Secondary Outcome Measures

Overall Survival (OS)

OS is the time from randomization to death due to any cause, from product-limit (Kaplan-Meier) method for censored data. The hypothesis was that pembrolizumab in combination with CRT is superior to placebo in combination with CRT; but based on the protocol, because the statistical criterion for success in the primary EFS hypothesis was not met, the OS hypothesis was not tested

Number of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with the study drug. An AE is any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy.

Number of Participants Discontinuing Study Drug Due to an AE

Change From Baseline in Global Health Status/Quality of Life (GHS/QoL)

The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) contains 30 items and measures five functional dimensions (physical, role, emotional, cognitive and social), three symptom items (fatigue, nausea/vomiting, and pain), six single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact), and a global health and QoL scale. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100, so that a higher score indicates a better overall GHS. A change from baseline of 10 points on the 100-point EORTC QLQ-C30 scale is considered as clinically relevant. Based on a constrained longitudinal data analysis (cLDA) model with the patient reported outcomes (PRO) scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of human papilloma virus (HPV) status and overall cancer stage.

Change From Baseline in Swallowing, Speech, and Pain Symptoms

EORTC QLQ Head and Neck Questionnaire (H&N35) consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality), Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Change from baseline in swallowing, speech, and pain symptoms was measured. A change from baseline of 10 points on the 100-point EORTC QLQ-H&N35 is considered as clinically relevant. Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.

Change From Baseline in Physical Functioning

Participant responded to 5 questions from the EORTC QLQ-C30 about their physical functioning scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100, where a higher score indicates a better quality of life. A change from baseline of 10 points on the 100-point scale is considered as clinically relevant. Based on a cLDA model with the PRO scores as the response variable with covariates for treatment, time, treatment by time interaction, and stratification factors of HPV status and overall cancer stage.

Full Information

NCT ID

NCT03040999

First Posted

February 1, 2017

Last Updated

May 12, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03040999

Brief Title

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)

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 5, 2017 (Actual)

Primary Completion Date

May 31, 2022 (Actual)

Study Completion Date

June 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Neoplasms

Keywords

Head and Neck Squamous Cell Carcinoma, Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (PD-L1), Programmed Cell Death Receptor Ligand 2 (PD-L2), PD1, PD-1, PDL1, PD-L1, PDL2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

804 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pembrolizumab + Cisplatin + CRT

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Cisplatin + CRT

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

KEYTRUDA®

Intervention Description

Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Normal saline or dextrose solution administered as an IV infusion Q3W

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol®, Platinol®-AQ

Intervention Description

100 mg/m^2 administered as an IV infusion Q3W

Intervention Type

Radiation

Intervention Name(s)

Accelerated Fractionation (AFX) Radiotherapy

Intervention Description

70 Gray (Gy) given in 35 fractions over 6 weeks

Intervention Type

Radiation

Intervention Name(s)

Standard Fractionation (SFX) Radiotherapy

Intervention Description

70 Gy given in 35 fractions over 7 weeks

Primary Outcome Measure Information:

Title

Event-free Survival (EFS)

Description

Time Frame

Up to approximately 62 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

Up to approximately 62 months

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

From time of first dose of study treatment until 90 days after last dose (up to approximately 19 months)

Title

Number of Participants Discontinuing Study Drug Due to an AE

Description

Time Frame

From time of first dose of study treatment until the end of treatment (up to approximately 16 months)

Title

Change From Baseline in Global Health Status/Quality of Life (GHS/QoL)

Description

Time Frame

Prior to the first dose of study treatment (Baseline) and up to Week 45

Title

Change From Baseline in Swallowing, Speech, and Pain Symptoms

Description

Time Frame

Prior to the first dose of study treatment (Baseline) and up to Week 45

Title

Change From Baseline in Physical Functioning

Description

Time Frame

Prior to the first dose of study treatment (Baseline) and up to Week 45

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

UCLA Medical Center ( Site 0273)

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

University of California San Francisco ( Site 0274)

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

St. Joseph Heritage Healthcare ( Site 0254)

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

Smilow Cancer Hospital at Yale New Haven ( Site 0256)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Rush University Medical Center ( Site 0260)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Indiana University ( Site 0264)

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Mary Bird Perkins Cancer Center at St. Tammany Parish Hospital ( Site 0281)

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

University of Massachusetts Memorial Medical Center ( Site 0285)

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

University of Michigan Hospital and Health Systems ( Site 0267)

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Barbara Ann Karmanos Cancer Institute ( Site 0272)

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 0290)

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65804

Country

United States

Facility Name

St. Vincent Healthcare Frontier Cancer Center ( Site 0286)

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada ( Site 8004)

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89169

Country

United States

Facility Name

University of Rochester - James P. Wilmot Cancer Center ( Site 0255)

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Oncology Hematology Care, Inc. ( Site 8003)

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Willamette Valley Cancer Institute and Research Center ( Site 8000)

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

St. Luke's Cancer Center - Anderson ( Site 0251)

City

Easton

State/Province

Pennsylvania

ZIP/Postal Code

18045

Country

United States

Facility Name

St. Francis Hospital Cancer Center ( Site 1461)

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Texas Oncology-Arlington North ( Site 8005)

City

Arlington

State/Province

Texas

ZIP/Postal Code

76014

Country

United States

Facility Name

Texas Oncology-Austin Central ( Site 8002)

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Texas Oncology PA ( Site 8001)

City

Longview

State/Province

Texas

ZIP/Postal Code

75601

Country

United States

Facility Name

University of Virginia Health System ( Site 0261)

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0269)

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Medical Oncology Associates (Summit Cancer Centers) ( Site 0257)

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Facility Name

Liverpool Hospital ( Site 0301)

City

Liverpool

State/Province

New South Wales (Australia)

ZIP/Postal Code

2170

Country

Australia

Facility Name

Blacktown Hospital Western Sydney Local Health District ( Site 0304)

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

Princess Alexandra Hospital ( Site 0305)

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Royal Brisbane and Women s Hospital ( Site 0302)

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Royal Adelaide Hospital ( Site 0303)

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Peter MacCallum Cancer Centre ( Site 0300)

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Landeskrankenhaus - Universitatsklinikum Graz ( Site 0601)

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Krankenhaus der Barmherzigen Schwestern Linz ( Site 0603)

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Landeskrankenhaus Salzburg ( Site 0600)

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Allgemeines Krankenhaus der Stadt Wien ( Site 0602)

City

Vienna/Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Cliniques Universitaires Saint Luc - Bruxelles ( Site 0651)

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZ Gent ( Site 0650)

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Leuven Campus Gasthuisberg ( Site 0652)

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

C.H.U. Sart Tilman-Service d'Oncologie Medicale ( Site 0654)

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Clinique et Maternite Sainte-Elisabeth ( Site 0653)

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0006)

City

Salvador

State/Province

Bahia

ZIP/Postal Code

40050-410

Country

Brazil

Facility Name

Centro Regional Integrado de Oncologia ( Site 0002)

City

Fortaleza

State/Province

Ceara

ZIP/Postal Code

60336-045

Country

Brazil

Facility Name

Liga Norte Riograndense Contra o Cancer ( Site 0005)

City

Natal

State/Province

Rio Grande Do Norte

ZIP/Postal Code

59075-740

Country

Brazil

Facility Name

Hospital Nossa Senhora da Conceicao ( Site 0001)

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Hospital de Clinicas de Porto Alegre ( Site 0011)

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0003)

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Instituto do Cancer de Sao Paulo - ICESP ( Site 0004)

City

Sao Paulo

State/Province

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Hospital das Clinicas da FMUSP de Ribeirao Preto ( Site 0008)

City

Ribeirao Preto

ZIP/Postal Code

14048-900

Country

Brazil

Facility Name

Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0010)

City

Rio de Janeiro

ZIP/Postal Code

20230-130

Country

Brazil

Facility Name

Tom Baker Cancer Centre ( Site 0063)

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Cross Cancer Institute ( Site 0064)

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Juravinski Cancer Centre ( Site 0062)

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

London Health Sciences Centre ( Site 0055)

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

The Ottawa Hospital - Cancer Care ( Site 0052)

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Princess Margaret Cancer Centre ( Site 0051)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X5

Country

Canada

Facility Name

McGill University Health Centre ( Site 0061)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0057)

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Hospital Pablo Tobon Uribe ( Site 0151)

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Fundacion Valle del Lili ( Site 0150)

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760032

Country

Colombia

Facility Name

Centro Medico Imbanaco de Cali S.A ( Site 0156)

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760042

Country

Colombia

Facility Name

Centro de Investigacion Clinica del Country ( Site 0155)

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

FN Brno. ( Site 0703)

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Fakultni Nemocnice Hradec Kralove ( Site 0705)

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc ( Site 0701)

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Fakultni nemocnice Ostrava ( Site 0702)

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Nemocnice Na Bulovce ( Site 0700)

City

Praha 8

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

2. LF UK a FN Motol ( Site 0704)

City

Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Centre Jean Bernard Laboratoire Mahe Meziani ( Site 0760)

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Clinique Francois Chenieux ( Site 0757)

City

Limoges

ZIP/Postal Code

87039

Country

France

Facility Name

Institut Claudius Regaud ( Site 0754)

City

Toulouse Cedex 09

ZIP/Postal Code

31059

Country

France

Facility Name

Institut De Cancerologie De Lorraine ( Site 0758)

City

Vandoeuvre les Nancy

ZIP/Postal Code

54500

Country

France

Facility Name

Institut Gustave Roussy ( Site 0759)

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Universitätsklinikum Erlangen ( Site 0801)

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

SRH Waldklinikum Gera GmbH ( Site 0802)

City

Gera

ZIP/Postal Code

07548

Country

Germany

Facility Name

Universitares Cancer Center Hamburg - UCCH ( Site 0811)

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Medizinische Hochschule Hannover ( Site 0807)

City

Hannover

ZIP/Postal Code

30325

Country

Germany

Facility Name

Universitaetsklinikum Schleswig-Holstein-Campus Luebeck ( Site 0803)

City

Luebeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

Klinikum der Universitaet Munchen ( Site 0810)

City

Munchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Universitaetsklinik Ulm ( Site 0804)

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

Rambam MC ( Site 0903)

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah Ein Karem Jerusalem ( Site 0902)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Rabin Medical Center ( Site 0904)

City

Petah Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Sheba MC ( Site 0901)

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Tel Aviv Sourasky Medical Center ( Site 0900)

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0954)

City

Modena

State/Province

ZIP/Postal Code

41124

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Careggi ( Site 0955)

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Istituto Nazionale Tumori ( Site 0950)

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Istituto Europeo di Oncologia ( Site 0953)

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Azienda Ospedaliera San Paolo ( Site 0952)

City

Milano

ZIP/Postal Code

20142

Country

Italy

Facility Name

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0951)

City

Napoli

ZIP/Postal Code

80121

Country

Italy

Facility Name

Istituto Oncologico Veneto ( Site 0957)

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Fondazione IRCCS - Policlinico San Matteo ( Site 0960)

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

National Cancer Center Hospital East ( Site 0350)

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Hokkaido University Hospital ( Site 0351)

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Hyogo Cancer Center ( Site 0354)

City

Akashi

State/Province

Hyogo

ZIP/Postal Code

673-8558

Country

Japan

Facility Name

Kagawa University Hospital ( Site 0359)

City

Kita-gun

State/Province

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

Miyagi Cancer Center ( Site 0353)

City

Natori

State/Province

Miyagi

ZIP/Postal Code

981-1293

Country

Japan

Facility Name

Chiba Cancer Center ( Site 0358)

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

Hiroshima University Hospital ( Site 0352)

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

Osaka International Cancer Institute ( Site 0355)

City

Osaka

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

Medical Hospital, Tokyo Medical And Dental University ( Site 0356)

City

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

Facility Name

The Cancer Institute Hospital of JFCR ( Site 0357)

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Chungbuk National University Hospital ( Site 0454)

City

Cheongju si

State/Province

Chungcheongbuk Do

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital ( Site 0453)

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Chungnam National University Hospital ( Site 0455)

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Severance Hospital Yonsei University Health System ( Site 0452)

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Samsung Medical Center ( Site 0450)

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Noordwest Ziekenhuisgroep NWZ ( Site 1350)

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

VU Medisch Centrum ( Site 1352)

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

UMCG ( Site 1351)

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

UMC St. Radboud ( Site 1356)

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Erasmus University Medical Center ( Site 1354)

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Capital & Coast District Health Board - Wellington Hospital ( Site 0400)

City

Wellington

State/Province

Newtown

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Dolnoslaskie Centrum Onkologii. ( Site 1001)

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

53-413

Country

Poland

Facility Name

Mazowiecki Szpital Onkologiczny ( Site 1015)

City

Wieliszew

State/Province

Mazowieckie

ZIP/Postal Code

05-135

Country

Poland

Facility Name

Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1005)

City

Bielsko-Biala

ZIP/Postal Code

43-300

Country

Poland

Facility Name

Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1007)

City

Gdynia

ZIP/Postal Code

81-519

Country

Poland

Facility Name

Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie ( Site 1010)

City

Gliwice

ZIP/Postal Code

44-101

Country

Poland

Facility Name

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1008)

City

Krakow

ZIP/Postal Code

31-826

Country

Poland

Facility Name

Zachodniopomorskie Centrum Onkologii ( Site 1013)

City

Szczecin

ZIP/Postal Code

71-730

Country

Poland

Facility Name

Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 1000)

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

H.U. Vall de Hebron ( Site 1052)

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Duran i Reynals ( Site 1053)

City

Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital Doce de Octubre ( Site 1054)

City

Madrid

ZIP/Postal Code

28024

Country

Spain

Facility Name

Hospital Universitario Ramon y Cajal ( Site 1055)

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Clinico San Carlos ( Site 1051)

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario Virgen de la Victoria ( Site 1056)

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Gral Universitario de Valencia ( Site 1050)

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Chang Gung Medical Foundation - Kaohsiung ( Site 0501)

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Taichung Veterans General Hospital ( Site 0506)

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

National Cheng Kung University Hospital ( Site 0503)

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

National Taiwan University Hospital ( Site 0500)

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

MacKay Memorial Hospital ( Site 0505)

City

Taipei

ZIP/Postal Code

105

Country

Taiwan

Facility Name

Taipei Veterans General Hospital ( Site 0504)

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Linkou Chang Gung Memorial Hospital ( Site 0502)

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1103)

City

Adana

ZIP/Postal Code

01250

Country

Turkey

Facility Name

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1102)

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Ankara Sehir Hastanesi ( Site 1108)

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

Facility Name

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 1100)

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Medipol Universite Hastanesi ( Site 1104)

City

Istanbul

ZIP/Postal Code

34214

Country

Turkey

Facility Name

Medical Park Izmir Hastanesi ( Site 1109)

City

Izmir

ZIP/Postal Code

35520

Country

Turkey

Facility Name

Kocaeli Universitesi Tip Fakultesi ( Site 1106)

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Inonu Universitesi Tip Fakultesi ( Site 1101)

City

Malatya

ZIP/Postal Code

44280

Country

Turkey

Facility Name

Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 1206)

City

Norwich

State/Province

Norfolk

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

University Hospital of North Staffordshire ( Site 1202)

City

Stoke-On-Trent

State/Province

Staffordshire

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

Facility Name

Ipswich Hospital ( Site 1207)

City

Ipswich

State/Province

Suffolk

ZIP/Postal Code

IP4 5PD

Country

United Kingdom

Facility Name

St Bartholomew s Hospital ( Site 1205)

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

The Royal Marsden Foundation Trust ( Site 1200)

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1204)

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Lancashire Teaching Hospitals NHS Foundation Trust ( Site 1208)

City

Preston

ZIP/Postal Code

PR2 9HT

Country

United Kingdom

Facility Name

University Hospital Southampton NHS Foundation Trust ( Site 1203)

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Royal Marsden NHS Foundation Trust ( Site 1201)

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

32490686

Citation

Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Figueiredo Lima IP, Pointreau Y, M Hughes BG, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncol. 2020 Jun;16(18):1235-1243. doi: 10.2217/fon-2020-0184. Epub 2020 Jun 3.

Results Reference

derived

Links:

URL

http://merckoncologyclinicaltrials.com

Description

Merck Oncology Clinical Trial Information

Learn more about this trial

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)

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