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Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)

Primary Purpose

Hepatocellular Carcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Programmed Cell Death 1 (PD-1, PD1), Programmed Cell Death Ligand 1 (PD-L1, PDL1), Checkpoint Inhibitor, Immunotherapy, Adjuvant

Eligibility Criteria

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

Inclusion Criteria:

  • Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.
  • Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation.
  • Has no radiologic evidence of disease prior to enrollment.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.
  • Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1.
  • Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1.
  • Has controlled hepatitis B (Hep B).
  • Has recovered adequately from toxicity and/or complications from the local intervention (surgical resection or local ablation) prior to starting study treatment.
  • If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment).
  • If undergoing surgical resection, has submitted a tumor tissue sample during Screening.
  • Has adequate organ function.

Exclusion Criteria:

  • Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years.
  • Has had esophageal or gastric variceal bleeding within the last 6 months.
  • Has clinically apparent ascites on physical examination.
  • Has had clinically diagnosed hepatic encephalopathy in the last 6 months.
  • Has received local therapy to liver ablation other than with radiofrequency or microwave ablation.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has dual active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection at study entry.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has known active tuberculosis (TB; Bacillus tuberculosis).
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Has received prior systemic anti-cancer therapy for HCC including investigational agents.
  • Is receiving any of the following prohibited concomitant therapies:1) Antineoplastic systemic chemotherapy or biological therapy; 2) Immunotherapy not specified in this protocol; 3) Investigational agents other than pembrolizumab; 4) Radiation therapy; 5) Oncological surgical therapy; or systemic glucocorticoids for any purpose other than to modulate symptoms from an AE that is suspected to have an immunologic etiology.
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.
  • 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 Cycle 1, Day 1.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Has had an allogenic tissue/solid organ transplant.

Sites / Locations

  • Banner MD Anderson Cancer Center ( Site 0026)
  • The University of Arizona Cancer Center - North Campus ( Site 0039)
  • City of Hope Medical Center ( Site 0027)
  • Smilow Cancer Hospital at Yale New Haven ( Site 0042)
  • Regional Cancer Center ( Site 0054)
  • Indiana University Simon Cancer Center ( Site 0075)
  • University of Iowa ( Site 0067)
  • James Graham Brown Cancer Center ( Site 0088)
  • University of Louisville ( Site 0059)
  • University Medical Center New Orleans ( Site 0014)
  • Massachusetts General Hospital ( Site 0062)
  • Boston Medical Center ( Site 0025)
  • Beth Israel Deaconess Medical Ctr. ( Site 0033)
  • University of Massachusetts Worcester ( Site 0017)
  • Henry Ford Hospital-GI/Hepatology Research ( Site 0047)
  • University of New Mexico ( Site 0041)
  • North Shore-Long Island Jewish Health System ( Site 0068)
  • Miami Valley Hospital South ( Site 0093)
  • University of Cincinnati Medical Center ( Site 0084)
  • ProMedica Flower Hospital ( Site 0090)
  • Stephenson Cancer Center ( Site 0045)
  • Vanderbilt Ingram Cancer Center ( Site 0006)
  • Baylor Scott & White Medical Center - Temple ( Site 0089)
  • Virginia Mason Medical Center ( Site 0028)
  • Hospital Universitario Austral ( Site 0795)
  • Fundación favaloro para la Docencia e Investigación Médica ( Site 0808)
  • Hospital Provincial del Centenario ( Site 0794)
  • Hospital Aleman ( Site 0806)
  • Hospital Italiano ( Site 0793)
  • Hospital Britanico de Buenos Aires ( Site 0792)
  • Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802)
  • Royal Prince Alfred Hospital AW ( Site 0225)
  • Liverpool Hospital ( Site 0226)
  • Princess Alexandra Hospital ( Site 0228)
  • Royal Adelaide Hospital ( Site 0234)
  • Monash Health ( Site 0233)
  • St Vincents Hospital Melbourne ( Site 0227)
  • Alfred Health ( Site 0230)
  • Royal Perth Hospital ( Site 0229)
  • University Hospital Antwerp (UZA) ( Site 0374)
  • Erasme Hospital ( Site 0376)
  • UZ Gent ( Site 0375)
  • UZ Leuven ( Site 0377)
  • CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813)
  • Hospital de Cancer de Pernambuco ( Site 0815)
  • Hospital de Clinicas de Porto Alegre ( Site 0824)
  • Clinica de Oncologia Reichow ( Site 0818)
  • Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820)
  • Hospital Paulistano ( Site 0829)
  • Instituto COI de Pesquisa Educacao e Gestao ( Site 0825)
  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826)
  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828)
  • A.C. Camargo Cancer Center ( Site 0827)
  • Casa de Saude Santa Marcelina ( Site 0821)
  • Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982)
  • Nova Scotia Health Authority QEII-HSC ( Site 0208)
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211)
  • McGill University Health Centre ( Site 0207)
  • Anhui Provincil Hospital South District ( Site 0181)
  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156)
  • Peking University People's Hospital ( Site 0191)
  • Beijing Cancer Hospital ( Site 0155)
  • Fujian Provincial Cancer Hospital ( Site 0165)
  • 900 Hospital of the Joint ( Site 0197)
  • Guangdong General Hospital ( Site 0166)
  • Southern Medical University Nanfang Hospital ( Site 0172)
  • Wuhan Union Hospital ( Site 0173)
  • Hubei Cancer Hospital ( Site 0189)
  • The Third Xiangya Hospital of Central South University ( Site 0167)
  • Hunan Provincial People Hospital ( Site 0192)
  • Hunan Cancer Hospital ( Site 0168)
  • Fudan University Shanghai Cancer Center ( Site 0161)
  • Zhongshan Hospital Fudan University ( Site 0193)
  • Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174)
  • Zhongshan Hospital affiliated to Fudan University ( Site 0153)
  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164)
  • West China Hospital of Sichuan University ( Site 0162)
  • Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157)
  • Zhejiang Cancer Hospital ( Site 0171)
  • Herlev Hospital ( Site 0421)
  • Aarhus Universitets hospital ( Site 0420)
  • Odense Universitets Hospital ( Site 0422)
  • HUS Hopital Hautepierre ( Site 0445)
  • Hopital de la Timone ( Site 0442)
  • CHU Bordeaux Haut-Leveque ( Site 0437)
  • CHU Rangueil ( Site 0441)
  • Hopital Beaujon ( Site 0439)
  • CHU Montpellier. ( Site 0443)
  • Hopital Claude Huriez CHRU LILLE ( Site 0440)
  • Hopital Paul Brousse ( Site 0447)
  • SLK-Kliniken Heilbronn GmbH ( Site 0460)
  • Universitaetsklinikum Tuebingen ( Site 0466)
  • Klinikum rechts der Isar der Technischen Universitaet ( Site 0470)
  • Universitaetsklinikum Wuerzburg ( Site 0468)
  • Krankenhaus Nord-West GmbH ( Site 0472)
  • Universitaetsklinikum Frankfurt ( Site 0467)
  • Medizinische Hochschule Hannover ( Site 0458)
  • Universitaetsklinikum Duesseldorf ( Site 0461)
  • Universitaetsklinikum Koeln ( Site 0463)
  • Staedtisches Klinikum Dresden ( Site 0471)
  • Universitatsklinikum Carl Gustav Carus ( Site 0459)
  • Charite - Campus Virchow Klinikum ( Site 0457)
  • Universitaetsklinikum Hamburg-Eppendorf ( Site 0469)
  • Prince of Wales Hospital ( Site 0268)
  • Pamela Youde Nethersole Eastern Hospital ( Site 0271)
  • Queen Mary Hospital ( Site 0267)
  • Tuen Mun Hospital ( Site 0272)
  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483)
  • SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482)
  • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484)
  • Semmelweis University ( Site 0480)
  • Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481)
  • St Vincent's University Hospital ( Site 0498)
  • Tallaght University Hospital ( Site 0499)
  • Rambam Medical Center ( Site 0524)
  • Haddassah Medical Organization - Ein Kerem ( Site 0519)
  • Rabin Medical Center ( Site 0520)
  • Chaim Sheba Medical Center ( Site 0523)
  • Sourasky Medical Center ( Site 0522)
  • A O U Policlinico di Modena ( Site 0548)
  • Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542)
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547)
  • Istituto Tumori Giovanni Paolo II ( Site 0543)
  • AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541)
  • Azienda Ospedaliero Universitaria Careggi ( Site 0549)
  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550)
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540)
  • Ospedale del Mare ( Site 0545)
  • Azienda Ospedaliero Universitaria Pisana ( Site 0546)
  • Ehime University Hospital ( Site 0123)
  • Kurume University Hospital ( Site 0119)
  • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102)
  • Kanazawa University Hospital ( Site 0111)
  • Kagawa University Hospital ( Site 0121)
  • Kagawa Prefectural Central Hospital ( Site 0122)
  • Toranomon Hospital Kajigaya ( Site 0109)
  • Yokohama City University Medical Center ( Site 0110)
  • Kindai University Hospital ( Site 0116)
  • Saitama Medical University Hospital ( Site 0104)
  • Kyorin University Hospital ( Site 0106)
  • Musashino Red Cross Hospital ( Site 0107)
  • Chiba University Hospital ( Site 0103)
  • National Hospital Organization Kyushu Medical Center ( Site 0118)
  • Hiroshima University Hospital ( Site 0117)
  • University Hospital, Kyoto Prefectural University of Medicine ( Site 0112)
  • Japanese Red Cross Osaka Hospital ( Site 0113)
  • Osaka Metropolitan University Hospital. ( Site 0114)
  • Saga-Ken Medical Centre Koseikan ( Site 0120)
  • Toranomon Hospital ( Site 0108)
  • The University of Tokyo Hospital ( Site 0105)
  • Wakayama Medical University Hospital ( Site 0115)
  • National Cancer Center ( Site 0314)
  • Seoul National University Bundang Hospital ( Site 0313)
  • Seoul National University Hospital ( Site 0312)
  • Severance Hospital Yonsei University Health System ( Site 0309)
  • Asan Medical Center ( Site 0310)
  • Samsung Medical Center ( Site 0311)
  • The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315)
  • Hospital Universiti Sains Malaysia ( Site 0295)
  • Penang Adventist Hospital ( Site 0289)
  • Gleneagles Penang ( Site 0290)
  • Sarawak General Hospital ( Site 0293)
  • Institut Kanser Negara - National Cancer Institute ( Site 0294)
  • University Malaya Medical Centre ( Site 0288)
  • Christchurch Hospital ( Site 0247)
  • Auckland City Hospital ( Site 0246)
  • Oslo Universitetssykehus HF. Ulleval ( Site 0433)
  • Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607)
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620)
  • MTZ Clinical Research Sp. z o. o. ( Site 0608)
  • Copernicus PL Sp. z o.o. ( Site 0603)
  • ID Clinic ( Site 0619)
  • SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606)
  • Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604)
  • Altay Regional Oncology Dispensary ( Site 0919)
  • Siberian Clinical Center of FMBA ( Site 0918)
  • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648)
  • Blokhin National Medical Oncology ( Site 0645)
  • City Clinical Hospital 1 na. NI. Pirogov ( Site 0662)
  • First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661)
  • Hadassah Medical-Clinical Research Department ( Site 0920)
  • National Medical Research Radiological Centre ( Site 0660)
  • Privolzhsky District Medical Center ( Site 0655)
  • Samara Regional Clinical Oncology Center ( Site 0656)
  • Road Hospital JSC Russian railways ( Site 0649)
  • Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665)
  • City Clinical Oncology Center ( Site 0646)
  • Tomsk Scientific Research Institute of Oncology ( Site 0657)
  • Hospital Central de Asturias ( Site 0667)
  • Hospital Universitari Parc Tauli ( Site 0681)
  • Hospital Universitario de Donostia ( Site 0671)
  • Complejo Hospitalario Universitario de Santiago ( Site 0668)
  • Hospital Universitario Puerta de Hierro ( Site 0678)
  • Hospital Universitari Vall d Hebron ( Site 0674)
  • Hospital General Universitario Gregorio Maranon ( Site 0676)
  • Hospital Ramon y Cajal ( Site 0673)
  • Hospital Universitario La Paz ( Site 0677)
  • Hospital Universitario Virgen del Rocio ( Site 0670)
  • Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682)
  • Skane University Hospital ( Site 0692)
  • Karolinska Universitetssjukhuset, Huddinge ( Site 0689)
  • Norrlands Universitetssjukhus ( Site 0687)
  • Sahlgrenska Universitetssjukhuset ( Site 0691)
  • Universitaetsspital Bern ( Site 0710)
  • University Hospital Basel ( Site 0709)
  • Kantonsspital St. Gallen ( Site 0708)
  • CHUV (centre hospitalier universitaire vaudois) ( Site 0712)
  • Kantonsspital Winterthur ( Site 0714)
  • Hopitaux Universitaires de Geneve HUG ( Site 0711)
  • Universitaetsspital Zurich ( Site 0713)
  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335)
  • China Medical University Hospital ( Site 0333)
  • National Cheng Kung University Hospital ( Site 0334)
  • National Taiwan University Hospital ( Site 0330)
  • Taipei Veterans General Hospital ( Site 0331)
  • Chang Gung Medical Foundation. Linkou ( Site 0332)
  • Ramathibodi Hospital. ( Site 0352)
  • Siriraj Hospital ( Site 0351)
  • Maharaj Nakorn Chiangmai Hospital ( Site 0353)
  • Srinagarind Hospital ( Site 0354)
  • Namik Kemal Universitesi Tip Fakultesi ( Site 0738)
  • Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733)
  • Gulhane Egitim ve Arastirma Hastanesi ( Site 0741)
  • Ankara Sehir Hastanesi ( Site 0731)
  • Adnan Menderes University Medical Faculty ( Site 0737)
  • Bezmialem Vakif University School of Medicine ( Site 0732)
  • Acıbadem Maslak Hastanesi ( Site 0742)
  • Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730)
  • Dokuz Eylul Universitesi ( Site 0740)
  • Konya Necmettin Erbakan University Medical Faculty ( Site 0736)
  • Inonu University Faculty of Medicine ( Site 0729)
  • VM Medical Park Hastanesi ( Site 0739)
  • Regional Clinical Onco Dispensary_ State Medical University ( Site 0782)
  • Regional Oncology Center of Kharkiv ( Site 0777)
  • National Cancer Institute of the MoH of Ukraine ( Site 0779)
  • Shalimov s NI of Surgery and Transplantation ( Site 0781)
  • MI Odessa Regional Oncological Centre ( Site 0776)
  • CI City Clinical Hospital # 3 ( Site 0783)
  • Universal Clinic Oberig-Oncology Center ( Site 0786)
  • Medical Center Dobrobut Clinic ( Site 0785)
  • Cambridge University Hospitals NHS Trust ( Site 0755)
  • Weston Park Hospital ( Site 0753)
  • The Beatson West of Scotland Cancer Centre ( Site 0750)
  • Kings College Hospital NHS Foundation Trust ( Site 0758)
  • Belfast City Hospital ( Site 0752)
  • The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757)
  • University Hospital Coventry and Warwickshire NHS Trust ( Site 0754)
  • Leeds Teaching Hospitals NHS Trust ( Site 0751)
  • Nottingham University Hospitals NHS Trust ( Site 0756)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pembrolizumab

Placebo

Arm Description

Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.

Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.

Outcomes

Primary Outcome Measures

Recurrence-Free Survival (RFS)
RFS is defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death), whichever occurs first.
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Percentage of Participants who Experience an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Percentage of Participants who Discontinue Study Treatment Due to an AE
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients, including a combined GHS/QoL (Items 29 and 30) scale. Per protocol, the change from baseline in the combined GHS/QoL score (range: 0-100) will be reported. Higher overall GHS/QoL scores indicate higher GHS/QoL.
Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported.
Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score
The EQ-5D-5L measured health-related outcomes, assessing 5 health state dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) on a 5-point scale from 1 (no problem) to 5 (extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health.

Full Information

First Posted
March 6, 2019
Last Updated
September 6, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03867084
Brief Title
Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)
Official Title
A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
October 31, 2027 (Anticipated)
Study Completion Date
August 31, 2029 (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 study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Programmed Cell Death 1 (PD-1, PD1), Programmed Cell Death Ligand 1 (PD-L1, PDL1), Checkpoint Inhibitor, Immunotherapy, Adjuvant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
950 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
IV infusion of Pembrolizumab 200 mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV infusion of 0.9% normal saline.
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS)
Description
RFS is defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death), whichever occurs first.
Time Frame
Up to ~6 years
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to ~8 years
Secondary Outcome Measure Information:
Title
Percentage of Participants who Experience an Adverse Event (AE)
Description
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Time Frame
Up to ~8 years
Title
Percentage of Participants who Discontinue Study Treatment Due to an AE
Description
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
Time Frame
Up to ~1 year
Title
Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients, including a combined GHS/QoL (Items 29 and 30) scale. Per protocol, the change from baseline in the combined GHS/QoL score (range: 0-100) will be reported. Higher overall GHS/QoL scores indicate higher GHS/QoL.
Time Frame
Baseline and time of last patient reported outcome (PRO) assessment (up to ~5 years)
Title
Change from Baseline in EORTC QLQ-Hepatocellular Carcinoma Module (EORTC QLQ-HCC18) Scale Score
Description
The EORTC QLQ-HCC18 is an HCC-specific questionnaire, administered in addition to the EORTC QLQ-C30, with scores ranging from 0-100. Higher scores indicate more severe symptoms/problems. Change from baseline in the EORTC QLQ-HCC18 scale score will be reported.
Time Frame
Baseline and time of last PRO assessment (up to ~5 years)
Title
Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Health Utility Score
Description
The EQ-5D-5L measured health-related outcomes, assessing 5 health state dimensions (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) on a 5-point scale from 1 (no problem) to 5 (extreme problems). The EQ-5D-5L also includes a graded (0 to 100) vertical visual analog scale on which the participant rates their general state of health.
Time Frame
Baseline and time of last PRO assessment (up to ~5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a diagnosis of HCC by radiological criteria and/or pathological confirmation. Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation. Has no radiologic evidence of disease prior to enrollment. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1. Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1. Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1. Has controlled hepatitis B (Hep B). Has recovered adequately from toxicity and/or complications from the local intervention (surgical resection or local ablation) prior to starting study treatment. If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment). If undergoing surgical resection, has submitted a tumor tissue sample during Screening. Has adequate organ function. Exclusion Criteria: Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years. Has had esophageal or gastric variceal bleeding within the last 6 months. Has clinically apparent ascites on physical examination. Has had clinically diagnosed hepatic encephalopathy in the last 6 months. Has received local therapy to liver ablation other than with radiofrequency or microwave ablation. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. Has an active infection requiring systemic therapy. Has dual active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection at study entry. Has a known history of human immunodeficiency virus (HIV) infection. Has known active tuberculosis (TB; Bacillus tuberculosis). Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). Has received prior systemic anti-cancer therapy for HCC including investigational agents. Is receiving any of the following prohibited concomitant therapies:1) Antineoplastic systemic chemotherapy or biological therapy; 2) Immunotherapy not specified in this protocol; 3) Investigational agents other than pembrolizumab; 4) Radiation therapy; 5) Oncological surgical therapy; or systemic glucocorticoids for any purpose other than to modulate symptoms from an AE that is suspected to have an immunologic etiology. Has received a live vaccine within 30 days prior to the first dose of study treatment. 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 Cycle 1, Day 1. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. Has an active autoimmune disease that has required systemic treatment in past 2 years. Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. Has had an allogenic tissue/solid organ transplant.
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
Banner MD Anderson Cancer Center ( Site 0026)
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
The University of Arizona Cancer Center - North Campus ( Site 0039)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
City of Hope Medical Center ( Site 0027)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Smilow Cancer Hospital at Yale New Haven ( Site 0042)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Regional Cancer Center ( Site 0054)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Indiana University Simon Cancer Center ( Site 0075)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa ( Site 0067)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
James Graham Brown Cancer Center ( Site 0088)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville ( Site 0059)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University Medical Center New Orleans ( Site 0014)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Massachusetts General Hospital ( Site 0062)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Medical Center ( Site 0025)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Ctr. ( Site 0033)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Massachusetts Worcester ( Site 0017)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Hospital-GI/Hepatology Research ( Site 0047)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
University of New Mexico ( Site 0041)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
North Shore-Long Island Jewish Health System ( Site 0068)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Miami Valley Hospital South ( Site 0093)
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
University of Cincinnati Medical Center ( Site 0084)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
ProMedica Flower Hospital ( Site 0090)
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Stephenson Cancer Center ( Site 0045)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center ( Site 0006)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor Scott & White Medical Center - Temple ( Site 0089)
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Virginia Mason Medical Center ( Site 0028)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Hospital Universitario Austral ( Site 0795)
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
B1629AHJ
Country
Argentina
Facility Name
Fundación favaloro para la Docencia e Investigación Médica ( Site 0808)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1096AAS
Country
Argentina
Facility Name
Hospital Provincial del Centenario ( Site 0794)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Hospital Aleman ( Site 0806)
City
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Facility Name
Hospital Italiano ( Site 0793)
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires ( Site 0792)
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802)
City
Santa Fe
ZIP/Postal Code
S3000BPJ
Country
Argentina
Facility Name
Royal Prince Alfred Hospital AW ( Site 0225)
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Liverpool Hospital ( Site 0226)
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Princess Alexandra Hospital ( Site 0228)
City
Woollongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital ( Site 0234)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Health ( Site 0233)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
St Vincents Hospital Melbourne ( Site 0227)
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Alfred Health ( Site 0230)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Perth Hospital ( Site 0229)
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
University Hospital Antwerp (UZA) ( Site 0374)
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
02650
Country
Belgium
Facility Name
Erasme Hospital ( Site 0376)
City
Bruxelles
State/Province
Bruxelles-Capitale, Region De
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Gent ( Site 0375)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven ( Site 0377)
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80810-050
Country
Brazil
Facility Name
Hospital de Cancer de Pernambuco ( Site 0815)
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50040-000
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre ( Site 0824)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Clinica de Oncologia Reichow ( Site 0818)
City
Blumenau
State/Province
Santa Catarina
ZIP/Postal Code
89010-340
Country
Brazil
Facility Name
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820)
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Hospital Paulistano ( Site 0829)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Instituto COI de Pesquisa Educacao e Gestao ( Site 0825)
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
A.C. Camargo Cancer Center ( Site 0827)
City
Sao Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Facility Name
Casa de Saude Santa Marcelina ( Site 0821)
City
Sao Paulo
ZIP/Postal Code
08270120
Country
Brazil
Facility Name
Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982)
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Nova Scotia Health Authority QEII-HSC ( Site 0208)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
McGill University Health Centre ( Site 0207)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Anhui Provincil Hospital South District ( Site 0181)
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230036
Country
China
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Peking University People's Hospital ( Site 0191)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Beijing Cancer Hospital ( Site 0155)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Fujian Provincial Cancer Hospital ( Site 0165)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
900 Hospital of the Joint ( Site 0197)
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Guangdong General Hospital ( Site 0166)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Southern Medical University Nanfang Hospital ( Site 0172)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Wuhan Union Hospital ( Site 0173)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hubei Cancer Hospital ( Site 0189)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
The Third Xiangya Hospital of Central South University ( Site 0167)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Hunan Provincial People Hospital ( Site 0192)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Hunan Cancer Hospital ( Site 0168)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Fudan University Shanghai Cancer Center ( Site 0161)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Zhongshan Hospital Fudan University ( Site 0193)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
Zhongshan Hospital affiliated to Fudan University ( Site 0153)
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
210000
Country
China
Facility Name
The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164)
City
XI An
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital of Sichuan University ( Site 0162)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157)
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
Zhejiang Cancer Hospital ( Site 0171)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Herlev Hospital ( Site 0421)
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Aarhus Universitets hospital ( Site 0420)
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Odense Universitets Hospital ( Site 0422)
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
HUS Hopital Hautepierre ( Site 0445)
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital de la Timone ( Site 0442)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13005
Country
France
Facility Name
CHU Bordeaux Haut-Leveque ( Site 0437)
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Rangueil ( Site 0441)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital Beaujon ( Site 0439)
City
Clichy
State/Province
Hauts-de-Seine
ZIP/Postal Code
92118
Country
France
Facility Name
CHU Montpellier. ( Site 0443)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Claude Huriez CHRU LILLE ( Site 0440)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Paul Brousse ( Site 0447)
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
SLK-Kliniken Heilbronn GmbH ( Site 0460)
City
Heilbronn
State/Province
Baden-Wurttemberg
ZIP/Postal Code
74078
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen ( Site 0466)
City
Tuebingen
State/Province
Baden-Wurttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitaet ( Site 0470)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Wuerzburg ( Site 0468)
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Krankenhaus Nord-West GmbH ( Site 0472)
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60488
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt ( Site 0467)
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Medizinische Hochschule Hannover ( Site 0458)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf ( Site 0461)
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitaetsklinikum Koeln ( Site 0463)
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Staedtisches Klinikum Dresden ( Site 0471)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus ( Site 0459)
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Charite - Campus Virchow Klinikum ( Site 0457)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf ( Site 0469)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Prince of Wales Hospital ( Site 0268)
City
Hong Kong
ZIP/Postal Code
000
Country
Hong Kong
Facility Name
Pamela Youde Nethersole Eastern Hospital ( Site 0271)
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital ( Site 0267)
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital ( Site 0272)
City
Tuen Mun
Country
Hong Kong
Facility Name
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483)
City
Kecskemét
State/Province
Bacs-Kiskun
ZIP/Postal Code
6000
Country
Hungary
Facility Name
SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484)
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Semmelweis University ( Site 0480)
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
St Vincent's University Hospital ( Site 0498)
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Tallaght University Hospital ( Site 0499)
City
Dublin
ZIP/Postal Code
D24 NR0A
Country
Ireland
Facility Name
Rambam Medical Center ( Site 0524)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Haddassah Medical Organization - Ein Kerem ( Site 0519)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center ( Site 0520)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center ( Site 0523)
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Sourasky Medical Center ( Site 0522)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
A O U Policlinico di Modena ( Site 0548)
City
Modena
State/Province
Abruzzo
ZIP/Postal Code
41025
Country
Italy
Facility Name
Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542)
City
Torino
State/Province
Piemonte
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547)
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
Facility Name
Istituto Tumori Giovanni Paolo II ( Site 0543)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541)
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Careggi ( Site 0549)
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550)
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540)
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale del Mare ( Site 0545)
City
Napoli
ZIP/Postal Code
80147
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana ( Site 0546)
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ehime University Hospital ( Site 0123)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kurume University Hospital ( Site 0119)
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Kanazawa University Hospital ( Site 0111)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kagawa University Hospital ( Site 0121)
City
Kita-gun
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital ( Site 0122)
City
Takamatsu
State/Province
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Toranomon Hospital Kajigaya ( Site 0109)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
213-8587
Country
Japan
Facility Name
Yokohama City University Medical Center ( Site 0110)
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kindai University Hospital ( Site 0116)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Saitama Medical University Hospital ( Site 0104)
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Kyorin University Hospital ( Site 0106)
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Musashino Red Cross Hospital ( Site 0107)
City
Musashino
State/Province
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Chiba University Hospital ( Site 0103)
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center ( Site 0118)
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Hiroshima University Hospital ( Site 0117)
City
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine ( Site 0112)
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital ( Site 0113)
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Osaka Metropolitan University Hospital. ( Site 0114)
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Saga-Ken Medical Centre Koseikan ( Site 0120)
City
Saga
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Toranomon Hospital ( Site 0108)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The University of Tokyo Hospital ( Site 0105)
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Wakayama Medical University Hospital ( Site 0115)
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
National Cancer Center ( Site 0314)
City
Goyang-si
State/Province
Kyonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital ( Site 0313)
City
Seongnam-si
State/Province
Kyonggi-do
ZIP/Postal Code
13605
Country
Korea, Republic of
Facility Name
Seoul National University Hospital ( Site 0312)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 0309)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 0310)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 0311)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Hospital Universiti Sains Malaysia ( Site 0295)
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Penang Adventist Hospital ( Site 0289)
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10350
Country
Malaysia
Facility Name
Gleneagles Penang ( Site 0290)
City
Penang
State/Province
Pulau Pinang
ZIP/Postal Code
10050
Country
Malaysia
Facility Name
Sarawak General Hospital ( Site 0293)
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Institut Kanser Negara - National Cancer Institute ( Site 0294)
City
Putrajaya Wilayah Persekutuan
State/Province
Wilayah Persekutuan Putrajaya
ZIP/Postal Code
62250
Country
Malaysia
Facility Name
University Malaya Medical Centre ( Site 0288)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Christchurch Hospital ( Site 0247)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Auckland City Hospital ( Site 0246)
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Oslo Universitetssykehus HF. Ulleval ( Site 0433)
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607)
City
Szklarska Poreba
State/Province
Dolnoslaskie
ZIP/Postal Code
58-580
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620)
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-081
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o. o. ( Site 0608)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Copernicus PL Sp. z o.o. ( Site 0603)
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-219
Country
Poland
Facility Name
ID Clinic ( Site 0619)
City
Myslowice
State/Province
Slaskie
ZIP/Postal Code
41-400
Country
Poland
Facility Name
SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606)
City
Olsztyn
State/Province
Warminsko-mazurskie
ZIP/Postal Code
10-228
Country
Poland
Facility Name
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604)
City
Koszalin
State/Province
Zachodniopomorskie
ZIP/Postal Code
75-581
Country
Poland
Facility Name
Altay Regional Oncology Dispensary ( Site 0919)
City
Barnaul
State/Province
Altayskiy Kray
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Siberian Clinical Center of FMBA ( Site 0918)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Blokhin National Medical Oncology ( Site 0645)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
City Clinical Hospital 1 na. NI. Pirogov ( Site 0662)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
119881
Country
Russian Federation
Facility Name
Hadassah Medical-Clinical Research Department ( Site 0920)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121205
Country
Russian Federation
Facility Name
National Medical Research Radiological Centre ( Site 0660)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Privolzhsky District Medical Center ( Site 0655)
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603109
Country
Russian Federation
Facility Name
Samara Regional Clinical Oncology Center ( Site 0656)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443031
Country
Russian Federation
Facility Name
Road Hospital JSC Russian railways ( Site 0649)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
City Clinical Oncology Center ( Site 0646)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Tomsk Scientific Research Institute of Oncology ( Site 0657)
City
Tomsk
State/Province
Tomskaya Oblast
ZIP/Postal Code
634028
Country
Russian Federation
Facility Name
Hospital Central de Asturias ( Site 0667)
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitari Parc Tauli ( Site 0681)
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Universitario de Donostia ( Site 0671)
City
San Sebastian
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago ( Site 0668)
City
Santiago de Compostela
State/Province
La Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro ( Site 0678)
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitari Vall d Hebron ( Site 0674)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 0676)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Ramon y Cajal ( Site 0673)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 0677)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio ( Site 0670)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682)
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Skane University Hospital ( Site 0692)
City
Malmo
State/Province
Skane Lan
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset, Huddinge ( Site 0689)
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Norrlands Universitetssjukhus ( Site 0687)
City
Umea
State/Province
Vasterbottens Lan
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset ( Site 0691)
City
Goteborg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
Universitaetsspital Bern ( Site 0710)
City
Bern
State/Province
Aargau
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
University Hospital Basel ( Site 0709)
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4056
Country
Switzerland
Facility Name
Kantonsspital St. Gallen ( Site 0708)
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
CHUV (centre hospitalier universitaire vaudois) ( Site 0712)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital Winterthur ( Site 0714)
City
Winterthur
State/Province
Zurich
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve HUG ( Site 0711)
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Universitaetsspital Zurich ( Site 0713)
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335)
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
China Medical University Hospital ( Site 0333)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 0334)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 0330)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital ( Site 0331)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang Gung Medical Foundation. Linkou ( Site 0332)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Ramathibodi Hospital. ( Site 0352)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Siriraj Hospital ( Site 0351)
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiangmai Hospital ( Site 0353)
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital ( Site 0354)
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Namik Kemal Universitesi Tip Fakultesi ( Site 0738)
City
Tekirdag
State/Province
Tekirdas
ZIP/Postal Code
59100
Country
Turkey
Facility Name
Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733)
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Facility Name
Gulhane Egitim ve Arastirma Hastanesi ( Site 0741)
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Ankara Sehir Hastanesi ( Site 0731)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Adnan Menderes University Medical Faculty ( Site 0737)
City
Aydin
ZIP/Postal Code
09010
Country
Turkey
Facility Name
Bezmialem Vakif University School of Medicine ( Site 0732)
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Acıbadem Maslak Hastanesi ( Site 0742)
City
Istanbul
ZIP/Postal Code
34457
Country
Turkey
Facility Name
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Facility Name
Dokuz Eylul Universitesi ( Site 0740)
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Konya Necmettin Erbakan University Medical Faculty ( Site 0736)
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Inonu University Faculty of Medicine ( Site 0729)
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
VM Medical Park Hastanesi ( Site 0739)
City
Mersin
ZIP/Postal Code
33440
Country
Turkey
Facility Name
Regional Clinical Onco Dispensary_ State Medical University ( Site 0782)
City
Chernivtsi
State/Province
Chernivetska Oblast
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
Regional Oncology Center of Kharkiv ( Site 0777)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61000
Country
Ukraine
Facility Name
National Cancer Institute of the MoH of Ukraine ( Site 0779)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Shalimov s NI of Surgery and Transplantation ( Site 0781)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03126
Country
Ukraine
Facility Name
MI Odessa Regional Oncological Centre ( Site 0776)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
CI City Clinical Hospital # 3 ( Site 0783)
City
Zaporizhzhia
State/Province
Zaporizka Oblast
ZIP/Postal Code
69032
Country
Ukraine
Facility Name
Universal Clinic Oberig-Oncology Center ( Site 0786)
City
Kyiv
ZIP/Postal Code
03057
Country
Ukraine
Facility Name
Medical Center Dobrobut Clinic ( Site 0785)
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
Cambridge University Hospitals NHS Trust ( Site 0755)
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Weston Park Hospital ( Site 0753)
City
Sheffield
State/Province
Derbyshire
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre ( Site 0750)
City
Glasgow
State/Province
Glasgow City
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Kings College Hospital NHS Foundation Trust ( Site 0758)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Belfast City Hospital ( Site 0752)
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757)
City
Birkenhead
State/Province
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
University Hospital Coventry and Warwickshire NHS Trust ( Site 0754)
City
Coventry
ZIP/Postal Code
CV3 2DX
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust ( Site 0751)
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust ( Site 0756)
City
Nottingham
ZIP/Postal Code
NG5 1PB
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
35421228
Citation
Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-937&&kw=3475-937
Description
Plain Language Summary

Learn more about this trial

Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)

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