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Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

Primary Purpose

Head and Neck Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab 200 mg
Radiotherapy 60 Gray/day
Radiotherapy 66 Gray/day
Radiotherapy 70 Gray/day
Cisplatin 100 mg/m^2
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
  • Is eligible for primary surgery based on investigator decision and per local practice
  • 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.
  • Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
  • Female participant that is not pregnant or breastfeeding
  • Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST version 1.1
  • Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Has results from testing of HPV status for oropharyngeal cancer defined as p16
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization

Exclusion Criteria:

  • Has Stage T4B and/or N3 LA HNSCC and/or distant metastases
  • 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 (HNC)
  • Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin.
  • Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor
  • Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start
  • Has received a live vaccine within 30 days prior to randomization
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy
  • Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis
  • Has Grade ≥2 audiometric hearing loss
  • Has Grade ≥2 neuropathy
  • Has Grade 3-4 bleeding due to the underlying malignancy
  • Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start
  • Has had previous allogeneic tissue/solid organ transplant
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C (defined as Hepatitis C virus [HCV] ribonucleic acid is detected).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Sites / Locations

  • Moores Cancer Center ( Site 1885)
  • University of Southern California Norris Comprehensive Cancer Center ( Site 1850)
  • Hoag Memoriall Hospital Presbyterian ( Site 2056)
  • UC Davis Health System ( Site 1864)
  • St. Joseph Heritage Healthcare ( Site 1806)
  • University of Colorado Cancer Center ( Site 1838)
  • MedStar Washington Hospital Center ( Site 2062)
  • George Washington University Medical Faculty Associates ( Site 2035)
  • University of Florida ( Site 1832)
  • University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)
  • AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054)
  • Orlando Health Cancer Institute ( Site 2061)
  • Saint Alphonsus Regional Medical Center ( Site 2021)
  • Beacon Cancer Care ( Site 2052)
  • Rush University Medical Center ( Site 1823)
  • NorthShore University HealthSystem ( Site 1812)
  • Loyola University Medical Center [Maywood, IL] ( Site 1817)
  • University of Kansas Cancer Center ( Site 2004)
  • University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069)
  • Ochsner Cancer Institute ( Site 2045)
  • University of Maryland ( Site 2031)
  • Dana Farber Cancer Center ( Site 1873)
  • University of Massachusetts Memorial Medical Center ( Site 1875)
  • Karmanos Cancer Institute ( Site 1870)
  • Henry Ford Health System ( Site 1803)
  • Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)
  • University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058)
  • Washington University School of Medicine ( Site 1800)
  • Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)
  • St. Vincent Healthcare Frontier Cancer Center ( Site 1818)
  • Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)
  • Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)
  • MSKCC-Bergen ( Site 2037)
  • Rutgers Cancer Institute of New Jersey ( Site 2071)
  • Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)
  • The University of New Mexico Comprehensive Cancer Center ( Site 1882)
  • Montefiore Einstein Center ( Site 2028)
  • Erie County Medical Center ( Site 2047)
  • Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)
  • Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)
  • Monter Cancer Center ( Site 2060)
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)
  • Memorial Sloan Kettering Cancer Center ( Site 1857)
  • Weill Cornell Medical College ( Site 2050)
  • Northwell Health Cancer Institute ( Site 2030)
  • Stony Brook University ( Site 2063)
  • Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)
  • Levine Cancer Institute ( Site 2003)
  • Wake Forest Compenhensive Cancer Center ( Site 2029)
  • Sanford Health Roger Maris Cancer Center ( Site 2034)
  • University Hospitals ( Site 2032)
  • The Ohio State University ( Site 2012)
  • Providence Portland Medical Center ( Site 1843)
  • Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)
  • Oregon Health Science University ( Site 1871)
  • St. Luke's University Health Network ( Site 1801)
  • Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)
  • Allegheny General Hospital ( Site 1833)
  • Sanford Cancer Center Oncology Clinic ( Site 1859)
  • Avera Cancer Institute- Research ( Site 2070)
  • Henry Joyce Cancer Clinic ( Site 1827)
  • UT Southwestern Medical Center ( Site 1841)
  • USA Clinical Trials ( Site 2068)
  • University of Utah, Huntsman Cancer Institute ( Site 1855)
  • University of Vermont Medical Center ( Site 2009)
  • UVA Health System - Emily Couric Cancer Center ( Site 1826)
  • Inova Schar Cancer Institute ( Site 2026)
  • Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)
  • Hospital Universitario Austral ( Site 0009)
  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019)
  • Hospital Britanico de Buenos Aires ( Site 0012)
  • Fundacion Estudios Clinicos-Oncology ( Site 0017)
  • Sanatorio Britanico ( Site 0013)
  • Instituto de Oncologia de Rosario ( Site 0002)
  • Hospital Provincial del Centenario ( Site 0008)
  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)
  • Hospital Aleman Buenos Aires Argentina ( Site 0004)
  • Instituto de Oncología Angel Roffo ( Site 0003)
  • CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)
  • The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)
  • Royal Brisbane and Women s Hospital ( Site 0050)
  • Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)
  • Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)
  • Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)
  • Medizinische Universität Wien ( Site 1903)
  • Hopital de Jolimont ( Site 0103)
  • UZ Gent ( Site 0101)
  • AZ Nikolaas ( Site 0104)
  • Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)
  • Centro Regional Integrado de Oncologia ( Site 0160)
  • Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)
  • Liga Norte Riograndense Contra o Cancer ( Site 0171)
  • Hospital Nossa Senhora da Conceicao ( Site 0165)
  • Hospital de Base de Sao Jose de Rio Preto ( Site 0153)
  • Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)
  • BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)
  • Cross Cancer Institute ( Site 0201)
  • Sunnybrook Research Institute ( Site 0211)
  • Princess Margaret Cancer Centre ( Site 0202)
  • McGill University Health Centre ( Site 0210)
  • CIUSSS de l'Estrie-CHUS ( Site 0209)
  • Fundacion Arturo Lopez Perez FALP ( Site 0251)
  • Clinica de la Costa S.A.S. ( Site 0307)
  • Centro de Investigacion Clinica del Country ( Site 0304)
  • Oncologos del Occidente S.A. ( Site 0310)
  • Centro Medico Imbanaco de Cali S.A ( Site 0300)
  • Centre Antoine Lacassagne ( Site 0351)
  • Hopital de la Timone ( Site 0356)
  • Institut Claudius Regaud IUCT Oncopole ( Site 0355)
  • Institut Gustave Roussy ( Site 0353)
  • Institut Sainte Catherine ( Site 0352)
  • Hopital Europeen Georges Pompidou ( Site 0358)
  • Institut Curie ( Site 0350)
  • Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)
  • Universitaetsklinikum Ulm ( Site 0402)
  • Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)
  • Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)
  • Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)
  • Universitaetsklinikum Frankfurt ( Site 0403)
  • Klinikum Kassel GmbH ( Site 0404)
  • Universitaetsklinikum Koeln ( Site 0413)
  • Universitätsklinikum Schleswig-Holstein ( Site 0411)
  • SRH Wald-Klinikum Gera GmbH ( Site 0406)
  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)
  • Universitaetsklinikum Hamburg Eppendorf ( Site 0407)
  • Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)
  • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450)
  • Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453)
  • Orszagos Onkologiai Intezet ( Site 0454)
  • St. James s Hospital ( Site 0500)
  • Rambam Health Care Campus-Oncology Division ( Site 0550)
  • Hadassah Medical Center. Ein Kerem ( Site 0554)
  • Rabin Medical Center ( Site 0552)
  • Chaim Sheba Medical Center. ( Site 0553)
  • Sourasky Medical Center ( Site 0551)
  • Aichi Cancer Center Hospital ( Site 0658)
  • National Cancer Center Hospital East ( Site 0661)
  • Hyogo Cancer Center ( Site 0656)
  • Kagawa University Hospital ( Site 0651)
  • Yokohama City University Hospital ( Site 0657)
  • Chiba Cancer Center ( Site 0652)
  • National Hospital Organization Kyushu Cancer Center ( Site 0660)
  • Hiroshima University Hospital ( Site 0655)
  • National Cancer Center Hospital ( Site 0650)
  • Tokyo Medical and Dental University Hospital ( Site 0654)
  • Tokyo Medical University Hospital ( Site 0659)
  • Chonnam National University Hwasun Hospital ( Site 0705)
  • National Cancer Center ( Site 0702)
  • The Catholic University of Korea St. Vincent s Hospital ( Site 0704)
  • Seoul National University Bundang Hospital ( Site 0703)
  • Severance Hospital, Yonsei University Health System ( Site 0701)
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
  • Szpitale Pomorskie Sp. z o.o. ( Site 0935)
  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)
  • Hospital de Braga ( Site 0951)
  • CHLN Hospital Santa Maria ( Site 0952)
  • Hospital CUF Descobertas ( Site 0953)
  • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)
  • N.N. Blokhin NMRCO ( Site 1005)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)
  • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)
  • Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)
  • ICO L Hospitalet ( Site 1208)
  • Hospital Clinico Universitario de Santiago ( Site 1207)
  • Hospital Vall D Hebron ( Site 1200)
  • Hospital Universitario La Paz ( Site 1201)
  • Hospital Universitario Virgen del Rocio ( Site 1206)
  • Universitaetsspital Zurich ( Site 1923)
  • Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)
  • Hopitaux Universitaires de Geneve HUG ( Site 1920)
  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)
  • Taichung Veterans General Hospital ( Site 1301)
  • National Cheng Kung University Hospital ( Site 1302)
  • National Taiwan University Hospital ( Site 1300)
  • Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)
  • Clinical oncology dispensary of Dnipro ( Site 1706)
  • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)
  • Ukrainian Center of Tomotherapy ( Site 1708)
  • PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)
  • Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)
  • National Cancer Institute of the MoH of Ukraine ( Site 1702)
  • LISOD. Hospital ( Site 1707)
  • Kyiv City Clinical Oncology Centre ( Site 1701)
  • Addenbrooke's Hospital ( Site 1610)
  • Castle Hill Hospital ( Site 1601)
  • Guy s & St Thomas NHS Foundation Trust ( Site 1604)
  • Royal Marsden Hospital - Fulham Road London ( Site 1609)
  • Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)
  • Weston Park Hospital ( Site 1607)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembro Neoadjuvant+Pembro SOC Adjuvant

No Neoadjuvant+SOC Adjuvant

Arm Description

Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles as a neoadjuvant prior to surgery. Following surgical resection, high risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 every 3 weeks (Q3W) for fifteen 21-day cycles plus standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 Q3W for fifteen 21-day cycles plus standard of care radiotherapy as adjuvant therapy.

Participants receive no neoadjuvant prior to surgery. Following surgical resection, high risk participants receive standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive standard of care radiotherapy as adjuvant therapy.

Outcomes

Primary Outcome Measures

Event-free Survival (EFS)
EFS is the time from the date of randomization to the date of first record of any of the following events: radiographic disease progression; local or distant progression or recurrence as assessed with imaging or biopsy as indicated; or death due to any cause. Radiographic disease progression during neoadjuvant phase that precludes surgery will be considered an event; a secondary malignancy will not be considered an event.

Secondary Outcome Measures

Major Pathological Response (mPR)
The percentage of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Pathological Complete Response (pCR)
Pathological complete response (pCR) is measured as the percentage of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.
Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL)
Change from baseline in the combined score of global health status (GHS)/quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 29 and 30. Participant responses to questions regarding overall health/QoL will be scored on a 7-point scale (1=Very poor to 7=Excellent) with a higher score indicating better overall health status.
Change From Baseline in Global Health Status/Physical Functioning Scales
Change from baseline in the combined score of physical functioning scale using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 1 through 5. Participant responses to questions regarding their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much) with a higher score indicating worse physical functioning.
Change from Baseline in Swallowing, Speech, and Pain Symptoms
Change from baseline in the combined score of swallowing, speech, and pain symptoms using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H&N35) items 31-38, 46, and 53-54. Participant responses to questions regarding problems with swallowing, speech and pain in the mouth will be scored on a 4-point scale (1=Not at all to 4=Very much) with a higher score indicating more problems.
Percentage of Participants Experiencing An Adverse Event (AEs)
Percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy
Percentage of Participants Discontinuing Study Drug Due to AEs
Percentage of participants discontinuing study drug due to an AE

Full Information

First Posted
November 6, 2018
Last Updated
October 6, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03765918
Brief Title
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Official Title
A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 17, 2018 (Actual)
Primary Completion Date
September 10, 2025 (Anticipated)
Study Completion Date
September 10, 2026 (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
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
704 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembro Neoadjuvant+Pembro SOC Adjuvant
Arm Type
Experimental
Arm Description
Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles as a neoadjuvant prior to surgery. Following surgical resection, high risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 every 3 weeks (Q3W) for fifteen 21-day cycles plus standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive 200 mg pembrolizumab by IV infusion administered on Day 1 Q3W for fifteen 21-day cycles plus standard of care radiotherapy as adjuvant therapy.
Arm Title
No Neoadjuvant+SOC Adjuvant
Arm Type
Active Comparator
Arm Description
Participants receive no neoadjuvant prior to surgery. Following surgical resection, high risk participants receive standard of care radiotherapy plus cisplatin 100 mg/m^2 by IV infusion on Day 1 Q3W for three 21-day cycles as adjuvant therapy. Following surgical resection, low risk participants receive standard of care radiotherapy as adjuvant therapy.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab 200 mg
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
200 mg administered by intravenous (IV) infusion on Day 1 of each 21-day cycle
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy 60 Gray/day
Intervention Description
Low risk participants administered 2 Gray/day in 30 fractions. Administered using intensity modulated radiation therapy.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy 66 Gray/day
Intervention Description
High risk participants administered 2 Gray/day in 33 fractions. Administered using intensity modulated radiation therapy.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy 70 Gray/day
Intervention Description
Participants with gross residual disease administered 2 Gray/day in 35 fractions. Administered using intensity modulated radiation therapy.
Intervention Type
Drug
Intervention Name(s)
Cisplatin 100 mg/m^2
Other Intervention Name(s)
Platinol®, Platinol-AQ®
Intervention Description
100 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle
Primary Outcome Measure Information:
Title
Event-free Survival (EFS)
Description
EFS is the time from the date of randomization to the date of first record of any of the following events: radiographic disease progression; local or distant progression or recurrence as assessed with imaging or biopsy as indicated; or death due to any cause. Radiographic disease progression during neoadjuvant phase that precludes surgery will be considered an event; a secondary malignancy will not be considered an event.
Time Frame
Up to ~80 months
Secondary Outcome Measure Information:
Title
Major Pathological Response (mPR)
Description
The percentage of participants with a major pathological response (mPR) as assessed by the Central Pathologist at the time of definitive surgery. mPR is defined as ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all the sampled regional lymph nodes.
Time Frame
Up to ~64 months
Title
Overall Survival (OS)
Description
OS is the time from randomization to death due to any cause.
Time Frame
Up to ~92 months
Title
Pathological Complete Response (pCR)
Description
Pathological complete response (pCR) is measured as the percentage of participants with a pathological complete response as assessed by the central pathologist at the time of definitive surgery. pCR is defined as having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes.
Time Frame
Up to ~64 months
Title
Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL)
Description
Change from baseline in the combined score of global health status (GHS)/quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 29 and 30. Participant responses to questions regarding overall health/QoL will be scored on a 7-point scale (1=Very poor to 7=Excellent) with a higher score indicating better overall health status.
Time Frame
Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months)
Title
Change From Baseline in Global Health Status/Physical Functioning Scales
Description
Change from baseline in the combined score of physical functioning scale using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) items 1 through 5. Participant responses to questions regarding their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much) with a higher score indicating worse physical functioning.
Time Frame
Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months)
Title
Change from Baseline in Swallowing, Speech, and Pain Symptoms
Description
Change from baseline in the combined score of swallowing, speech, and pain symptoms using the European Organization for Research and Treatment of Cancer Head and Neck Questionnaire (EORTC QLQ-H&N35) items 31-38, 46, and 53-54. Participant responses to questions regarding problems with swallowing, speech and pain in the mouth will be scored on a 4-point scale (1=Not at all to 4=Very much) with a higher score indicating more problems.
Time Frame
Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months)
Title
Percentage of Participants Experiencing An Adverse Event (AEs)
Description
Percentage of participants experiencing any sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study therapy
Time Frame
From time of first dose of study treatment until the end of follow-up (up to ~92 months)
Title
Percentage of Participants Discontinuing Study Drug Due to AEs
Description
Percentage of participants discontinuing study drug due to an AE
Time Frame
From time of first dose of study treatment until the end of treatment (up to 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries. Is eligible for primary surgery based on investigator decision and per local practice 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. Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy Female participant that is not pregnant or breastfeeding Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST version 1.1 Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated Has results from testing of HPV status for oropharyngeal cancer defined as p16 Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization Exclusion Criteria: Has Stage T4B and/or N3 LA HNSCC and/or distant metastases 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 (HNC) Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin. Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start Has received a live vaccine within 30 days prior to randomization Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis Has Grade ≥2 audiometric hearing loss Has Grade ≥2 neuropathy Has Grade 3-4 bleeding due to the underlying malignancy Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start Has had previous allogeneic tissue/solid organ transplant Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs Has an active autoimmune disease that has required systemic treatment in past 2 years Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis Has an active infection requiring systemic therapy Has a known history of human immunodeficiency virus (HIV) infection Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C (defined as Hepatitis C virus [HCV] ribonucleic acid is detected). Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
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
Moores Cancer Center ( Site 1885)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0698
Country
United States
Facility Name
University of Southern California Norris Comprehensive Cancer Center ( Site 1850)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Hoag Memoriall Hospital Presbyterian ( Site 2056)
City
Newport Beach
State/Province
California
ZIP/Postal Code
92688
Country
United States
Facility Name
UC Davis Health System ( Site 1864)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
St. Joseph Heritage Healthcare ( Site 1806)
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
University of Colorado Cancer Center ( Site 1838)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MedStar Washington Hospital Center ( Site 2062)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
George Washington University Medical Faculty Associates ( Site 2035)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Florida ( Site 1832)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Orlando Health Cancer Institute ( Site 2061)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center ( Site 2021)
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Beacon Cancer Care ( Site 2052)
City
Post Falls
State/Province
Idaho
ZIP/Postal Code
83854
Country
United States
Facility Name
Rush University Medical Center ( Site 1823)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
NorthShore University HealthSystem ( Site 1812)
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Loyola University Medical Center [Maywood, IL] ( Site 1817)
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Cancer Center ( Site 2004)
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Ochsner Cancer Institute ( Site 2045)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland ( Site 2031)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana Farber Cancer Center ( Site 1873)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center ( Site 1875)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Karmanos Cancer Institute ( Site 1870)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System ( Site 1803)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Washington University School of Medicine ( Site 1800)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
St. Vincent Healthcare Frontier Cancer Center ( Site 1818)
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
MSKCC-Bergen ( Site 2037)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 2071)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
The University of New Mexico Comprehensive Cancer Center ( Site 1882)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Montefiore Einstein Center ( Site 2028)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Erie County Medical Center ( Site 2047)
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Monter Cancer Center ( Site 2060)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center ( Site 1857)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College ( Site 2050)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Northwell Health Cancer Institute ( Site 2030)
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Stony Brook University ( Site 2063)
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
Levine Cancer Institute ( Site 2003)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Wake Forest Compenhensive Cancer Center ( Site 2029)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27357
Country
United States
Facility Name
Sanford Health Roger Maris Cancer Center ( Site 2034)
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
University Hospitals ( Site 2032)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University ( Site 2012)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Providence Portland Medical Center ( Site 1843)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health Science University ( Site 1871)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's University Health Network ( Site 1801)
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny General Hospital ( Site 1833)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Sanford Cancer Center Oncology Clinic ( Site 1859)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Avera Cancer Institute- Research ( Site 2070)
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Henry Joyce Cancer Clinic ( Site 1827)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
UT Southwestern Medical Center ( Site 1841)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
USA Clinical Trials ( Site 2068)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah, Huntsman Cancer Institute ( Site 1855)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
University of Vermont Medical Center ( Site 2009)
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
UVA Health System - Emily Couric Cancer Center ( Site 1826)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Schar Cancer Institute ( Site 2026)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Hospital Universitario Austral ( Site 0009)
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Facility Name
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires ( Site 0012)
City
Ciudad de Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Fundacion Estudios Clinicos-Oncology ( Site 0017)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Sanatorio Britanico ( Site 0013)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
Instituto de Oncologia de Rosario ( Site 0002)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Hospital Provincial del Centenario ( Site 0008)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)
City
Buenos Aires
ZIP/Postal Code
1012
Country
Argentina
Facility Name
Hospital Aleman Buenos Aires Argentina ( Site 0004)
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Instituto de Oncología Angel Roffo ( Site 0003)
City
Buenos Aires
ZIP/Postal Code
C1417DTB
Country
Argentina
Facility Name
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)
City
San Juan
ZIP/Postal Code
J5402DIL
Country
Argentina
Facility Name
The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane and Women s Hospital ( Site 0050)
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien ( Site 1903)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hopital de Jolimont ( Site 0103)
City
Haine Saint Paul
State/Province
Hainaut
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Gent ( Site 0101)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Nikolaas ( Site 0104)
City
Sint-Niklaas
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Centro Regional Integrado de Oncologia ( Site 0160)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60336-232
Country
Brazil
Facility Name
Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)
City
Ipatinga
State/Province
Minas Gerais
ZIP/Postal Code
35162-189
Country
Brazil
Facility Name
Liga Norte Riograndense Contra o Cancer ( Site 0171)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao ( Site 0165)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91359-200
Country
Brazil
Facility Name
Hospital de Base de Sao Jose de Rio Preto ( Site 0153)
City
Sao Jose do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)
City
Rio de Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Cross Cancer Institute ( Site 0201)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Sunnybrook Research Institute ( Site 0211)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0202)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Centre ( Site 0210)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CIUSSS de l'Estrie-CHUS ( Site 0209)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Fundacion Arturo Lopez Perez FALP ( Site 0251)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Clinica de la Costa S.A.S. ( Site 0307)
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Centro de Investigacion Clinica del Country ( Site 0304)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Oncologos del Occidente S.A. ( Site 0310)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
661002
Country
Colombia
Facility Name
Centro Medico Imbanaco de Cali S.A ( Site 0300)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Centre Antoine Lacassagne ( Site 0351)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital de la Timone ( Site 0356)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13385
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0355)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy ( Site 0353)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Institut Sainte Catherine ( Site 0352)
City
Avignon
State/Province
Vaucluse
ZIP/Postal Code
84918
Country
France
Facility Name
Hopital Europeen Georges Pompidou ( Site 0358)
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Institut Curie ( Site 0350)
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm ( Site 0402)
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89075
Country
Germany
Facility Name
Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt ( Site 0403)
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum Kassel GmbH ( Site 0404)
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34125
Country
Germany
Facility Name
Universitaetsklinikum Koeln ( Site 0413)
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein ( Site 0411)
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH ( Site 0406)
City
Gera
State/Province
Thuringen
ZIP/Postal Code
07548
Country
Germany
Facility Name
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitaetsklinikum Hamburg Eppendorf ( Site 0407)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)
City
Pecs
State/Province
Baranya
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450)
City
Szolnok
State/Province
Jasz-Nagykun-Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453)
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet ( Site 0454)
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
St. James s Hospital ( Site 0500)
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Facility Name
Rambam Health Care Campus-Oncology Division ( Site 0550)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Medical Center. Ein Kerem ( Site 0554)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center ( Site 0552)
City
Petah Tikva
ZIP/Postal Code
4963211
Country
Israel
Facility Name
Chaim Sheba Medical Center. ( Site 0553)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0551)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Aichi Cancer Center Hospital ( Site 0658)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 0661)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hyogo Cancer Center ( Site 0656)
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kagawa University Hospital ( Site 0651)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Yokohama City University Hospital ( Site 0657)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Chiba Cancer Center ( Site 0652)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center ( Site 0660)
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Hiroshima University Hospital ( Site 0655)
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 0650)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital ( Site 0654)
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Tokyo Medical University Hospital ( Site 0659)
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital ( Site 0705)
City
Hwasun Gun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
National Cancer Center ( Site 0702)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Vincent s Hospital ( Site 0704)
City
Gyeonggi-do
State/Province
Kyonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0703)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System ( Site 0701)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Szpitale Pomorskie Sp. z o.o. ( Site 0935)
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-159
Country
Poland
Facility Name
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44101
Country
Poland
Facility Name
Hospital de Braga ( Site 0951)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
CHLN Hospital Santa Maria ( Site 0952)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital CUF Descobertas ( Site 0953)
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Facility Name
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
N.N. Blokhin NMRCO ( Site 1005)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)
City
Yaroslavl
State/Province
Yaroslavskaya Oblast
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
ICO L Hospitalet ( Site 1208)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago ( Site 1207)
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Vall D Hebron ( Site 1200)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 1201)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio ( Site 1206)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Universitaetsspital Zurich ( Site 1923)
City
Zuerich
State/Province
Aargau
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve HUG ( Site 1920)
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Taichung Veterans General Hospital ( Site 1301)
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 1302)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 1300)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)
City
Dnipropetrovsk
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Clinical oncology dispensary of Dnipro ( Site 1706)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49055
Country
Ukraine
Facility Name
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Ukrainian Center of Tomotherapy ( Site 1708)
City
Kropyvnitskiy
State/Province
Kirovohradska Oblast
ZIP/Postal Code
25011
Country
Ukraine
Facility Name
PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)
City
Kropyvnytskyi
State/Province
Kirovohradska Oblast
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)
City
Kapitanivka Village
State/Province
Kyivska Oblast
ZIP/Postal Code
08111
Country
Ukraine
Facility Name
National Cancer Institute of the MoH of Ukraine ( Site 1702)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
LISOD. Hospital ( Site 1707)
City
Pliuty
State/Province
Kyiv
ZIP/Postal Code
08720
Country
Ukraine
Facility Name
Kyiv City Clinical Oncology Centre ( Site 1701)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Addenbrooke's Hospital ( Site 1610)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Castle Hill Hospital ( Site 1601)
City
Cottingham-Hull
State/Province
Kingston Upon Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Guy s & St Thomas NHS Foundation Trust ( Site 1604)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Fulham Road London ( Site 1609)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)
City
London
State/Province
London, City Of
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Weston Park Hospital ( Site 1607)
City
Sheffield
ZIP/Postal Code
S10 2SJ
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
Links:
URL
http://merckclinicaltrials.com
Description
Merck Clinical Trial Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-689&&kw=3475-689
Description
Plain Language Summary

Learn more about this trial

Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)

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