MedPath

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)

Phase 3
Active, not recruiting
Conditions
Hepatocellular Carcinoma
Interventions
Registration Number
NCT03867084
Lead Sponsor
Merck Sharp & Dohme LLC
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
950
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 โ‰ฅ4 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.
Read More
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 (โ‰ฅGrade 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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PembrolizumabPembrolizumabParticipants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
PlaceboPlaceboParticipants receive IV placebo on Day 1 of each 21-day cycle for up to 17 cycles.
Primary Outcome Measures
NameTimeMethod
Recurrence-Free Survival (RFS)Up to ~6 years

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)Up to ~8 years

OS is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants who Experience an Adverse Event (AE)Up to ~8 years

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 AEUp to ~1 year

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 ScoreBaseline and time of last patient reported outcome (PRO) assessment (up to ~5 years)

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 ScoreBaseline and time of last PRO assessment (up to ~5 years)

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 ScoreBaseline and time of last PRO assessment (up to ~5 years)

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.

Trial Locations

Locations (249)

UZ Leuven ( Site 0377)

๐Ÿ‡ง๐Ÿ‡ช

Leuven, Vlaams-Brabant, Belgium

City of Hope Medical Center ( Site 0027)

๐Ÿ‡บ๐Ÿ‡ธ

Duarte, California, United States

Fundaciรณn favaloro para la Docencia e Investigaciรณn Mรฉdica ( Site 0808)

๐Ÿ‡ฆ๐Ÿ‡ท

Buenos Aires, Caba, Argentina

The University of Arizona Cancer Center - North Campus ( Site 0039)

๐Ÿ‡บ๐Ÿ‡ธ

Tucson, Arizona, United States

University Medical Center New Orleans ( Site 0014)

๐Ÿ‡บ๐Ÿ‡ธ

New Orleans, Louisiana, United States

Hospital Britanico de Buenos Aires ( Site 0792)

๐Ÿ‡ฆ๐Ÿ‡ท

Buenos Aires, Argentina

University of Massachusetts Worcester ( Site 0017)

๐Ÿ‡บ๐Ÿ‡ธ

Worcester, Massachusetts, United States

Krankenhaus Nord-West GmbH ( Site 0472)

๐Ÿ‡ฉ๐Ÿ‡ช

Frankfurt am Main, Hessen, Germany

Hospital Universitario Austral ( Site 0795)

๐Ÿ‡ฆ๐Ÿ‡ท

Pilar, Buenos Aires, Argentina

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826)

๐Ÿ‡ง๐Ÿ‡ท

Sao Paulo, Brazil

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211)

๐Ÿ‡จ๐Ÿ‡ฆ

Montreal, Quebec, Canada

Universitaetsklinikum Frankfurt ( Site 0467)

๐Ÿ‡ฉ๐Ÿ‡ช

Frankfurt, Hessen, Germany

Baylor Scott & White Medical Center - Temple ( Site 0089)

๐Ÿ‡บ๐Ÿ‡ธ

Temple, Texas, United States

Universitatsklinikum Carl Gustav Carus ( Site 0459)

๐Ÿ‡ฉ๐Ÿ‡ช

Dresden, Sachsen, Germany

Hospital Paulistano ( Site 0829)

๐Ÿ‡ง๐Ÿ‡ท

Sรฃo Paulo, Sao Paulo, Brazil

Erasme Hospital ( Site 0376)

๐Ÿ‡ง๐Ÿ‡ช

Bruxelles, Bruxelles-Capitale, Region De, Belgium

University of New Mexico ( Site 0041)

๐Ÿ‡บ๐Ÿ‡ธ

Albuquerque, New Mexico, United States

Alfred Health ( Site 0230)

๐Ÿ‡ฆ๐Ÿ‡บ

Melbourne, Victoria, Australia

Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802)

๐Ÿ‡ฆ๐Ÿ‡ท

Santa Fe, Argentina

Instituto COI de Pesquisa Educacao e Gestao ( Site 0825)

๐Ÿ‡ง๐Ÿ‡ท

Rio de Janeiro, Brazil

University of Iowa ( Site 0067)

๐Ÿ‡บ๐Ÿ‡ธ

Iowa City, Iowa, United States

Princess Alexandra Hospital ( Site 0228)

๐Ÿ‡ฆ๐Ÿ‡บ

Woollongabba, Queensland, Australia

Hospital Aleman ( Site 0806)

๐Ÿ‡ฆ๐Ÿ‡ท

Buenos Aires, Argentina

Monash Health ( Site 0233)

๐Ÿ‡ฆ๐Ÿ‡บ

Clayton, Victoria, Australia

Hospital Italiano ( Site 0793)

๐Ÿ‡ฆ๐Ÿ‡ท

Buenos Aires, Argentina

Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820)

๐Ÿ‡ง๐Ÿ‡ท

Itajai, Santa Catarina, Brazil

Beijing Cancer Hospital ( Site 0155)

๐Ÿ‡จ๐Ÿ‡ณ

Beijing, Beijing, China

UZ Gent ( Site 0375)

๐Ÿ‡ง๐Ÿ‡ช

Gent, Oost-Vlaanderen, Belgium

Hopital de la Timone ( Site 0442)

๐Ÿ‡ซ๐Ÿ‡ท

Marseille, Bouches-du-Rhone, France

CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813)

๐Ÿ‡ง๐Ÿ‡ท

Curitiba, Parana, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828)

๐Ÿ‡ง๐Ÿ‡ท

Sao Paulo, Brazil

A.C. Camargo Cancer Center ( Site 0827)

๐Ÿ‡ง๐Ÿ‡ท

Sao Paulo, Brazil

Casa de Saude Santa Marcelina ( Site 0821)

๐Ÿ‡ง๐Ÿ‡ท

Sao Paulo, Brazil

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550)

๐Ÿ‡ฎ๐Ÿ‡น

Milano, Italy

Istituto Tumori Giovanni Paolo II ( Site 0543)

๐Ÿ‡ฎ๐Ÿ‡น

Bari, Italy

Universitaetsklinikum Hamburg-Eppendorf ( Site 0469)

๐Ÿ‡ฉ๐Ÿ‡ช

Hamburg, Germany

Staedtisches Klinikum Dresden ( Site 0471)

๐Ÿ‡ฉ๐Ÿ‡ช

Dresden, Sachsen, Germany

Nova Scotia Health Authority QEII-HSC ( Site 0208)

๐Ÿ‡จ๐Ÿ‡ฆ

Halifax, Nova Scotia, Canada

SLK-Kliniken Heilbronn GmbH ( Site 0460)

๐Ÿ‡ฉ๐Ÿ‡ช

Heilbronn, Baden-Wurttemberg, Germany

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547)

๐Ÿ‡ฎ๐Ÿ‡น

Palermo, Sicilia, Italy

Semmelweis University ( Site 0480)

๐Ÿ‡ญ๐Ÿ‡บ

Budapest, Hungary

Toranomon Hospital Kajigaya ( Site 0109)

๐Ÿ‡ฏ๐Ÿ‡ต

Kawasaki, Kanagawa, Japan

Somogy Megyei Kaposi Mรณr Oktatรณ Kรณrhรกz-Oncology center ( Site 0484)

๐Ÿ‡ญ๐Ÿ‡บ

Kaposvรกr, Somogy, Hungary

CHU Montpellier. ( Site 0443)

๐Ÿ‡ซ๐Ÿ‡ท

Montpellier, Herault, France

Rambam Medical Center ( Site 0524)

๐Ÿ‡ฎ๐Ÿ‡ฑ

Haifa, Israel

Sourasky Medical Center ( Site 0522)

๐Ÿ‡ฎ๐Ÿ‡ฑ

Tel Aviv, Israel

Hopital Paul Brousse ( Site 0447)

๐Ÿ‡ซ๐Ÿ‡ท

Villejuif, Val-de-Marne, France

Ehime University Hospital ( Site 0123)

๐Ÿ‡ฏ๐Ÿ‡ต

Toon, Ehime, Japan

Medizinische Hochschule Hannover ( Site 0458)

๐Ÿ‡ฉ๐Ÿ‡ช

Hannover, Niedersachsen, Germany

Universitaetsklinikum Koeln ( Site 0463)

๐Ÿ‡ฉ๐Ÿ‡ช

Koeln, Nordrhein-Westfalen, Germany

SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482)

๐Ÿ‡ญ๐Ÿ‡บ

Szeged, Csongrad, Hungary

Kurume University Hospital ( Site 0119)

๐Ÿ‡ฏ๐Ÿ‡ต

Kurume, Fukuoka, Japan

Kagawa Prefectural Central Hospital ( Site 0122)

๐Ÿ‡ฏ๐Ÿ‡ต

Takamatsu, Kagawa, Japan

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540)

๐Ÿ‡ฎ๐Ÿ‡น

Milano, Italy

Haddassah Medical Organization - Ein Kerem ( Site 0519)

๐Ÿ‡ฎ๐Ÿ‡ฑ

Jerusalem, Israel

Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102)

๐Ÿ‡ฏ๐Ÿ‡ต

Sapporo, Hokkaido, Japan

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483)

๐Ÿ‡ญ๐Ÿ‡บ

Kecskemรฉt, Bacs-Kiskun, Hungary

Gulhane Egitim ve Arastirma Hastanesi ( Site 0741)

๐Ÿ‡น๐Ÿ‡ท

Ankara, Turkey

Tallaght University Hospital ( Site 0499)

๐Ÿ‡ฎ๐Ÿ‡ช

Dublin, Ireland

Yokohama City University Medical Center ( Site 0110)

๐Ÿ‡ฏ๐Ÿ‡ต

Yokohama, Kanagawa, Japan

Kagawa University Hospital ( Site 0121)

๐Ÿ‡ฏ๐Ÿ‡ต

Kita-gun, Kagawa, Japan

Rabin Medical Center ( Site 0520)

๐Ÿ‡ฎ๐Ÿ‡ฑ

Petah Tikva, Israel

Kanazawa University Hospital ( Site 0111)

๐Ÿ‡ฏ๐Ÿ‡ต

Kanazawa, Ishikawa, Japan

University Hospital, Kyoto Prefectural University of Medicine ( Site 0112)

๐Ÿ‡ฏ๐Ÿ‡ต

Kyoto, Japan

Toranomon Hospital ( Site 0108)

๐Ÿ‡ฏ๐Ÿ‡ต

Tokyo, Japan

Seoul National University Bundang Hospital ( Site 0313)

๐Ÿ‡ฐ๐Ÿ‡ท

Seongnam-si, Kyonggi-do, Korea, Republic of

ID Clinic ( Site 0619)

๐Ÿ‡ต๐Ÿ‡ฑ

Myslowice, Slaskie, Poland

University Hospital Coventry and Warwickshire NHS Trust ( Site 0754)

๐Ÿ‡ฌ๐Ÿ‡ง

Coventry, United Kingdom

Namik Kemal Universitesi Tip Fakultesi ( Site 0738)

๐Ÿ‡น๐Ÿ‡ท

Tekirdag, Tekirdas, Turkey

Universal Clinic Oberig-Oncology Center ( Site 0786)

๐Ÿ‡บ๐Ÿ‡ฆ

Kyiv, Ukraine

Kings College Hospital NHS Foundation Trust ( Site 0758)

๐Ÿ‡ฌ๐Ÿ‡ง

London, London, City Of, United Kingdom

Leeds Teaching Hospitals NHS Trust ( Site 0751)

๐Ÿ‡ฌ๐Ÿ‡ง

Leeds, United Kingdom

Acฤฑbadem Maslak Hastanesi ( Site 0742)

๐Ÿ‡น๐Ÿ‡ท

Istanbul, Turkey

Medical Center Dobrobut Clinic ( Site 0785)

๐Ÿ‡บ๐Ÿ‡ฆ

Kyiv, Ukraine

Gรถztepe Prof. Dr. Sรผleyman Yalรงฤฑn ลžehir Hastanesi-oncology ( Site 0730)

๐Ÿ‡น๐Ÿ‡ท

Istanbul, Turkey

Dokuz Eylul Universitesi ( Site 0740)

๐Ÿ‡น๐Ÿ‡ท

Izmir, Turkey

Nottingham University Hospitals NHS Trust ( Site 0756)

๐Ÿ‡ฌ๐Ÿ‡ง

Nottingham, United Kingdom

The Beatson West of Scotland Cancer Centre ( Site 0750)

๐Ÿ‡ฌ๐Ÿ‡ง

Glasgow, Glasgow City, United Kingdom

Banner MD Anderson Cancer Center ( Site 0026)

๐Ÿ‡บ๐Ÿ‡ธ

Gilbert, Arizona, United States

Regional Cancer Center ( Site 0054)

๐Ÿ‡บ๐Ÿ‡ธ

Fort Myers, Florida, United States

Royal Prince Alfred Hospital AW ( Site 0225)

๐Ÿ‡ฆ๐Ÿ‡บ

Camperdown, New South Wales, Australia

Royal Adelaide Hospital ( Site 0234)

๐Ÿ‡ฆ๐Ÿ‡บ

Adelaide, South Australia, Australia

St Vincents Hospital Melbourne ( Site 0227)

๐Ÿ‡ฆ๐Ÿ‡บ

Fitzroy, Victoria, Australia

Royal Perth Hospital ( Site 0229)

๐Ÿ‡ฆ๐Ÿ‡บ

Perth, Western Australia, Australia

Hospital de Clinicas de Porto Alegre ( Site 0824)

๐Ÿ‡ง๐Ÿ‡ท

Porto Alegre, Rio Grande Do Sul, Brazil

University Hospital Basel ( Site 0709)

๐Ÿ‡จ๐Ÿ‡ญ

Basel, Basel-Stadt, Switzerland

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156)

๐Ÿ‡จ๐Ÿ‡ณ

Beijing, Beijing, China

Guangdong General Hospital ( Site 0166)

๐Ÿ‡จ๐Ÿ‡ณ

Guangzhou, Guangdong, China

Wuhan Union Hospital ( Site 0173)

๐Ÿ‡จ๐Ÿ‡ณ

Wuhan, Hubei, China

Fujian Provincial Cancer Hospital ( Site 0165)

๐Ÿ‡จ๐Ÿ‡ณ

Fuzhou, Fujian, China

900 Hospital of the Joint ( Site 0197)

๐Ÿ‡จ๐Ÿ‡ณ

Fuzhou, Fujian, China

Hunan Cancer Hospital ( Site 0168)

๐Ÿ‡จ๐Ÿ‡ณ

Changsha, Hunan, China

Fudan University Shanghai Cancer Center ( Site 0161)

๐Ÿ‡จ๐Ÿ‡ณ

Shanghai, Shanghai, China

Zhongshan Hospital Fudan University ( Site 0193)

๐Ÿ‡จ๐Ÿ‡ณ

Shanghai, Shanghai, China

Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174)

๐Ÿ‡จ๐Ÿ‡ณ

Shanghai, Shanghai, China

Zhongshan Hospital affiliated to Fudan University ( Site 0153)

๐Ÿ‡จ๐Ÿ‡ณ

Shanghai, Shanghai, China

West China Hospital of Sichuan University ( Site 0162)

๐Ÿ‡จ๐Ÿ‡ณ

Chengdu, Sichuan, China

Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157)

๐Ÿ‡จ๐Ÿ‡ณ

Urumqi, Xinjiang, China

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164)

๐Ÿ‡จ๐Ÿ‡ณ

XI An, Shanxi, China

Zhejiang Cancer Hospital ( Site 0171)

๐Ÿ‡จ๐Ÿ‡ณ

Hangzhou, Zhejiang, China

Herlev Hospital ( Site 0421)

๐Ÿ‡ฉ๐Ÿ‡ฐ

Herlev, Hovedstaden, Denmark

Aarhus Universitets hospital ( Site 0420)

๐Ÿ‡ฉ๐Ÿ‡ฐ

Aarhus N, Midtjylland, Denmark

Odense Universitets Hospital ( Site 0422)

๐Ÿ‡ฉ๐Ÿ‡ฐ

Odense C, Syddanmark, Denmark

Indiana University Simon Cancer Center ( Site 0075)

๐Ÿ‡บ๐Ÿ‡ธ

Indianapolis, Indiana, United States

University of Cincinnati Medical Center ( Site 0084)

๐Ÿ‡บ๐Ÿ‡ธ

Cincinnati, Ohio, United States

Stephenson Cancer Center ( Site 0045)

๐Ÿ‡บ๐Ÿ‡ธ

Oklahoma City, Oklahoma, United States

Massachusetts General Hospital ( Site 0062)

๐Ÿ‡บ๐Ÿ‡ธ

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Ctr. ( Site 0033)

๐Ÿ‡บ๐Ÿ‡ธ

Boston, Massachusetts, United States

Henry Ford Hospital-GI/Hepatology Research ( Site 0047)

๐Ÿ‡บ๐Ÿ‡ธ

Detroit, Michigan, United States

Vanderbilt Ingram Cancer Center ( Site 0006)

๐Ÿ‡บ๐Ÿ‡ธ

Nashville, Tennessee, United States

Virginia Mason Medical Center ( Site 0028)

๐Ÿ‡บ๐Ÿ‡ธ

Seattle, Washington, United States

CHU Bordeaux Haut-Leveque ( Site 0437)

๐Ÿ‡ซ๐Ÿ‡ท

Pessac, Gironde, France

Hopital Beaujon ( Site 0439)

๐Ÿ‡ซ๐Ÿ‡ท

Clichy, Hauts-de-Seine, France

St Vincent's University Hospital ( Site 0498)

๐Ÿ‡ฎ๐Ÿ‡ช

Dublin, Ireland

A O U Policlinico di Modena ( Site 0548)

๐Ÿ‡ฎ๐Ÿ‡น

Modena, Abruzzo, Italy

HUS Hopital Hautepierre ( Site 0445)

๐Ÿ‡ซ๐Ÿ‡ท

Strasbourg, Bas-Rhin, France

Hopital Claude Huriez CHRU LILLE ( Site 0440)

๐Ÿ‡ซ๐Ÿ‡ท

Lille, Nord, France

Hospital Provincial del Centenario ( Site 0794)

๐Ÿ‡ฆ๐Ÿ‡ท

Rosario, Santa Fe, Argentina

Belfast City Hospital ( Site 0752)

๐Ÿ‡ฌ๐Ÿ‡ง

Belfast, Northern Ireland, United Kingdom

Hospital de Cancer de Pernambuco ( Site 0815)

๐Ÿ‡ง๐Ÿ‡ท

Recife, Pernambuco, Brazil

Clinica de Oncologia Reichow ( Site 0818)

๐Ÿ‡ง๐Ÿ‡ท

Blumenau, Santa Catarina, Brazil

Kantonsspital Winterthur ( Site 0714)

๐Ÿ‡จ๐Ÿ‡ญ

Winterthur, Zurich, Switzerland

China Medical University Hospital ( Site 0333)

๐Ÿ‡จ๐Ÿ‡ณ

Taichung, Taiwan

Institut Kanser Negara - National Cancer Institute ( Site 0294)

๐Ÿ‡ฒ๐Ÿ‡พ

Putrajaya Wilayah Persekutuan, Wilayah Persekutuan Putrajaya, Malaysia

Regional Oncology Center of Kharkiv ( Site 0777)

๐Ÿ‡บ๐Ÿ‡ฆ

Kharkiv, Kharkivska Oblast, Ukraine

Universitaetsspital Zurich ( Site 0713)

๐Ÿ‡จ๐Ÿ‡ญ

Zurich, Switzerland

Weston Park Hospital ( Site 0753)

๐Ÿ‡ฌ๐Ÿ‡ง

Sheffield, Derbyshire, United Kingdom

MI Odessa Regional Oncological Centre ( Site 0776)

๐Ÿ‡บ๐Ÿ‡ฆ

Odesa, Odeska Oblast, Ukraine

The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757)

๐Ÿ‡ฌ๐Ÿ‡ง

Birkenhead, Wirral, United Kingdom

Cambridge University Hospitals NHS Trust ( Site 0755)

๐Ÿ‡ฌ๐Ÿ‡ง

Cambridge, Cambridgeshire, United Kingdom

Shalimov s NI of Surgery and Transplantation ( Site 0781)

๐Ÿ‡บ๐Ÿ‡ฆ

Kyiv, Kyivska Oblast, Ukraine

CI City Clinical Hospital # 3 ( Site 0783)

๐Ÿ‡บ๐Ÿ‡ฆ

Zaporizhzhia, Zaporizka Oblast, Ukraine

AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541)

๐Ÿ‡ฎ๐Ÿ‡น

Bologna, Italy

Azienda Ospedaliero Universitaria Careggi ( Site 0549)

๐Ÿ‡ฎ๐Ÿ‡น

Firenze, Italy

Ospedale del Mare ( Site 0545)

๐Ÿ‡ฎ๐Ÿ‡น

Napoli, Italy

Ankara Sehir Hastanesi ( Site 0731)

๐Ÿ‡น๐Ÿ‡ท

Ankara, Turkey

Kindai University Hospital ( Site 0116)

๐Ÿ‡ฏ๐Ÿ‡ต

Osakasayama, Osaka, Japan

Saga-Ken Medical Centre Koseikan ( Site 0120)

๐Ÿ‡ฏ๐Ÿ‡ต

Saga, Japan

The University of Tokyo Hospital ( Site 0105)

๐Ÿ‡ฏ๐Ÿ‡ต

Tokyo, Japan

Boston Medical Center ( Site 0025)

๐Ÿ‡บ๐Ÿ‡ธ

Boston, Massachusetts, United States

North Shore-Long Island Jewish Health System ( Site 0068)

๐Ÿ‡บ๐Ÿ‡ธ

Lake Success, New York, United States

Miami Valley Hospital South ( Site 0093)

๐Ÿ‡บ๐Ÿ‡ธ

Centerville, Ohio, United States

Liverpool Hospital ( Site 0226)

๐Ÿ‡ฆ๐Ÿ‡บ

Liverpool, New South Wales, Australia

University Hospital Antwerp (UZA) ( Site 0374)

๐Ÿ‡ง๐Ÿ‡ช

Edegem, Antwerpen, Belgium

Southern Medical University Nanfang Hospital ( Site 0172)

๐Ÿ‡จ๐Ÿ‡ณ

Guangzhou, Guangdong, China

Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982)

๐Ÿ‡ง๐Ÿ‡ฌ

Plovdiv, Bulgaria

Peking University People's Hospital ( Site 0191)

๐Ÿ‡จ๐Ÿ‡ณ

Beijing, Beijing, China

Anhui Provincil Hospital South District ( Site 0181)

๐Ÿ‡จ๐Ÿ‡ณ

Hefei, Anhui, China

McGill University Health Centre ( Site 0207)

๐Ÿ‡จ๐Ÿ‡ฆ

Montreal, Quebec, Canada

The Third Xiangya Hospital of Central South University ( Site 0167)

๐Ÿ‡จ๐Ÿ‡ณ

Changsha, Hunan, China

Hunan Provincial People Hospital ( Site 0192)

๐Ÿ‡จ๐Ÿ‡ณ

Changsha, Hunan, China

Hubei Cancer Hospital ( Site 0189)

๐Ÿ‡จ๐Ÿ‡ณ

Wuhan, Hubei, China

CHU Rangueil ( Site 0441)

๐Ÿ‡ซ๐Ÿ‡ท

Toulouse, Haute-Garonne, France

Universitaetsklinikum Wuerzburg ( Site 0468)

๐Ÿ‡ฉ๐Ÿ‡ช

Wuerzburg, Bayern, Germany

Klinikum rechts der Isar der Technischen Universitaet ( Site 0470)

๐Ÿ‡ฉ๐Ÿ‡ช

Muenchen, Bayern, Germany

Universitaetsklinikum Duesseldorf ( Site 0461)

๐Ÿ‡ฉ๐Ÿ‡ช

Duesseldorf, Nordrhein-Westfalen, Germany

Charite - Campus Virchow Klinikum ( Site 0457)

๐Ÿ‡ฉ๐Ÿ‡ช

Berlin, Germany

Universitaetsklinikum Tuebingen ( Site 0466)

๐Ÿ‡ฉ๐Ÿ‡ช

Tuebingen, Baden-Wurttemberg, Germany

Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481)

๐Ÿ‡ญ๐Ÿ‡บ

Debrecen, Hungary

Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542)

๐Ÿ‡ฎ๐Ÿ‡น

Torino, Piemonte, Italy

Chaim Sheba Medical Center ( Site 0523)

๐Ÿ‡ฎ๐Ÿ‡ฑ

Ramat Gan, Israel

Azienda Ospedaliero Universitaria Pisana ( Site 0546)

๐Ÿ‡ฎ๐Ÿ‡น

Pisa, Italy

Musashino Red Cross Hospital ( Site 0107)

๐Ÿ‡ฏ๐Ÿ‡ต

Musashino, Tokyo, Japan

Saitama Medical University Hospital ( Site 0104)

๐Ÿ‡ฏ๐Ÿ‡ต

Iruma-gun, Saitama, Japan

Kyorin University Hospital ( Site 0106)

๐Ÿ‡ฏ๐Ÿ‡ต

Mitaka, Tokyo, Japan

Chiba University Hospital ( Site 0103)

๐Ÿ‡ฏ๐Ÿ‡ต

Chiba, Japan

National Hospital Organization Kyushu Medical Center ( Site 0118)

๐Ÿ‡ฏ๐Ÿ‡ต

Fukuoka, Japan

Hiroshima University Hospital ( Site 0117)

๐Ÿ‡ฏ๐Ÿ‡ต

Hiroshima, Japan

Japanese Red Cross Osaka Hospital ( Site 0113)

๐Ÿ‡ฏ๐Ÿ‡ต

Osaka, Japan

Osaka Metropolitan University Hospital. ( Site 0114)

๐Ÿ‡ฏ๐Ÿ‡ต

Osaka, Japan

Severance Hospital Yonsei University Health System ( Site 0309)

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Asan Medical Center ( Site 0310)

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Wakayama Medical University Hospital ( Site 0115)

๐Ÿ‡ฏ๐Ÿ‡ต

Wakayama, Japan

Samsung Medical Center ( Site 0311)

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

National Cancer Center ( Site 0314)

๐Ÿ‡ฐ๐Ÿ‡ท

Goyang-si, Kyonggi-do, Korea, Republic of

Seoul National University Hospital ( Site 0312)

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315)

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Hospital Universiti Sains Malaysia ( Site 0295)

๐Ÿ‡ฒ๐Ÿ‡พ

Kubang Kerian, Kelantan, Malaysia

Penang Adventist Hospital ( Site 0289)

๐Ÿ‡ฒ๐Ÿ‡พ

George Town, Pulau Pinang, Malaysia

Gleneagles Penang ( Site 0290)

๐Ÿ‡ฒ๐Ÿ‡พ

Penang, Pulau Pinang, Malaysia

Sarawak General Hospital ( Site 0293)

๐Ÿ‡ฒ๐Ÿ‡พ

Kuching, Sarawak, Malaysia

University Malaya Medical Centre ( Site 0288)

๐Ÿ‡ฒ๐Ÿ‡พ

Kuala Lumpur, Malaysia

Auckland City Hospital ( Site 0246)

๐Ÿ‡ณ๐Ÿ‡ฟ

Auckland, New Zealand

Christchurch Hospital ( Site 0247)

๐Ÿ‡ณ๐Ÿ‡ฟ

Christchurch, Canterbury, New Zealand

MTZ Clinical Research Sp. z o. o. ( Site 0608)

๐Ÿ‡ต๐Ÿ‡ฑ

Warsaw, Mazowieckie, Poland

Oslo Universitetssykehus HF. Ulleval ( Site 0433)

๐Ÿ‡ณ๐Ÿ‡ด

Oslo, Norway

Copernicus PL Sp. z o.o. ( Site 0603)

๐Ÿ‡ต๐Ÿ‡ฑ

Gdansk, Pomorskie, Poland

Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607)

๐Ÿ‡ต๐Ÿ‡ฑ

Szklarska Poreba, Dolnoslaskie, Poland

Siberian Clinical Center of FMBA ( Site 0918)

๐Ÿ‡ท๐Ÿ‡บ

Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation

Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604)

๐Ÿ‡ต๐Ÿ‡ฑ

Koszalin, Zachodniopomorskie, Poland

Altay Regional Oncology Dispensary ( Site 0919)

๐Ÿ‡ท๐Ÿ‡บ

Barnaul, Altayskiy Kray, Russian Federation

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648)

๐Ÿ‡ท๐Ÿ‡บ

Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation

Blokhin National Medical Oncology ( Site 0645)

๐Ÿ‡ท๐Ÿ‡บ

Moscow, Moskva, Russian Federation

National Medical Research Radiological Centre ( Site 0660)

๐Ÿ‡ท๐Ÿ‡บ

Moscow, Moskva, Russian Federation

City Clinical Hospital 1 na. NI. Pirogov ( Site 0662)

๐Ÿ‡ท๐Ÿ‡บ

Moscow, Moskva, Russian Federation

Hadassah Medical-Clinical Research Department ( Site 0920)

๐Ÿ‡ท๐Ÿ‡บ

Moscow, Moskva, Russian Federation

First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661)

๐Ÿ‡ท๐Ÿ‡บ

Moscow, Moskva, Russian Federation

Privolzhsky District Medical Center ( Site 0655)

๐Ÿ‡ท๐Ÿ‡บ

Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation

Samara Regional Clinical Oncology Center ( Site 0656)

๐Ÿ‡ท๐Ÿ‡บ

Samara, Samarskaya Oblast, Russian Federation

Road Hospital JSC Russian railways ( Site 0649)

๐Ÿ‡ท๐Ÿ‡บ

Saint Petersburg, Sankt-Peterburg, Russian Federation

Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665)

๐Ÿ‡ท๐Ÿ‡บ

Saint Petersburg, Sankt-Peterburg, Russian Federation

City Clinical Oncology Center ( Site 0646)

๐Ÿ‡ท๐Ÿ‡บ

Saint Petersburg, Sankt-Peterburg, Russian Federation

Hospital Universitario de Donostia ( Site 0671)

๐Ÿ‡ช๐Ÿ‡ธ

San Sebastian, Gipuzkoa, Spain

Hospital Central de Asturias ( Site 0667)

๐Ÿ‡ช๐Ÿ‡ธ

Oviedo, Asturias, Spain

Tomsk Scientific Research Institute of Oncology ( Site 0657)

๐Ÿ‡ท๐Ÿ‡บ

Tomsk, Tomskaya Oblast, Russian Federation

Hospital Universitario Puerta de Hierro ( Site 0678)

๐Ÿ‡ช๐Ÿ‡ธ

Majadahonda, Madrid, Spain

Complejo Hospitalario Universitario de Santiago ( Site 0668)

๐Ÿ‡ช๐Ÿ‡ธ

Santiago de Compostela, La Coruna, Spain

Hospital Universitari Vall d Hebron ( Site 0674)

๐Ÿ‡ช๐Ÿ‡ธ

Barcelona, Spain

Hospital Ramon y Cajal ( Site 0673)

๐Ÿ‡ช๐Ÿ‡ธ

Madrid, Spain

Hospital General Universitario Gregorio Maranon ( Site 0676)

๐Ÿ‡ช๐Ÿ‡ธ

Madrid, Spain

Hospital Universitario La Paz ( Site 0677)

๐Ÿ‡ช๐Ÿ‡ธ

Madrid, Spain

Hospital Universitario Virgen del Rocio ( Site 0670)

๐Ÿ‡ช๐Ÿ‡ธ

Sevilla, Spain

Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682)

๐Ÿ‡ช๐Ÿ‡ธ

Zaragoza, Spain

Skane University Hospital ( Site 0692)

๐Ÿ‡ธ๐Ÿ‡ช

Malmo, Skane Lan, Sweden

Karolinska Universitetssjukhuset, Huddinge ( Site 0689)

๐Ÿ‡ธ๐Ÿ‡ช

Stockholm, Stockholms Lan, Sweden

Norrlands Universitetssjukhus ( Site 0687)

๐Ÿ‡ธ๐Ÿ‡ช

Umea, Vasterbottens Lan, Sweden

Universitaetsspital Bern ( Site 0710)

๐Ÿ‡จ๐Ÿ‡ญ

Bern, Aargau, Switzerland

CHUV (centre hospitalier universitaire vaudois) ( Site 0712)

๐Ÿ‡จ๐Ÿ‡ญ

Lausanne, Vaud, Switzerland

Kantonsspital St. Gallen ( Site 0708)

๐Ÿ‡จ๐Ÿ‡ญ

St. Gallen, Sankt Gallen, Switzerland

Sahlgrenska Universitetssjukhuset ( Site 0691)

๐Ÿ‡ธ๐Ÿ‡ช

Goteborg, Vastra Gotalands Lan, Sweden

National Cheng Kung University Hospital ( Site 0334)

๐Ÿ‡จ๐Ÿ‡ณ

Tainan, Taiwan

Hopitaux Universitaires de Geneve HUG ( Site 0711)

๐Ÿ‡จ๐Ÿ‡ญ

Geneve, Switzerland

National Taiwan University Hospital ( Site 0330)

๐Ÿ‡จ๐Ÿ‡ณ

Taipei, Taiwan

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335)

๐Ÿ‡จ๐Ÿ‡ณ

Kaohsiung, Taiwan

Taipei Veterans General Hospital ( Site 0331)

๐Ÿ‡จ๐Ÿ‡ณ

Taipei, Taiwan

Chang Gung Medical Foundation. Linkou ( Site 0332)

๐Ÿ‡จ๐Ÿ‡ณ

Taoyuan, Taiwan

Ramathibodi Hospital. ( Site 0352)

๐Ÿ‡น๐Ÿ‡ญ

Bangkok, Krung Thep Maha Nakhon, Thailand

Siriraj Hospital ( Site 0351)

๐Ÿ‡น๐Ÿ‡ญ

Bangkok, Krung Thep Maha Nakhon, Thailand

Maharaj Nakorn Chiangmai Hospital ( Site 0353)

๐Ÿ‡น๐Ÿ‡ญ

Chiang Mai, Thailand

Srinagarind Hospital ( Site 0354)

๐Ÿ‡น๐Ÿ‡ญ

Khon Kaen, Thailand

Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733)

๐Ÿ‡น๐Ÿ‡ท

Adana, Turkey

Adnan Menderes University Medical Faculty ( Site 0737)

๐Ÿ‡น๐Ÿ‡ท

Aydin, Turkey

Bezmialem Vakif University School of Medicine ( Site 0732)

๐Ÿ‡น๐Ÿ‡ท

Istanbul, Turkey

Konya Necmettin Erbakan University Medical Faculty ( Site 0736)

๐Ÿ‡น๐Ÿ‡ท

Konya, Turkey

Inonu University Faculty of Medicine ( Site 0729)

๐Ÿ‡น๐Ÿ‡ท

Malatya, Turkey

VM Medical Park Hastanesi ( Site 0739)

๐Ÿ‡น๐Ÿ‡ท

Mersin, Turkey

Regional Clinical Onco Dispensary_ State Medical University ( Site 0782)

๐Ÿ‡บ๐Ÿ‡ฆ

Chernivtsi, Chernivetska Oblast, Ukraine

National Cancer Institute of the MoH of Ukraine ( Site 0779)

๐Ÿ‡บ๐Ÿ‡ฆ

Kyiv, Kyivska Oblast, Ukraine

ProMedica Flower Hospital ( Site 0090)

๐Ÿ‡บ๐Ÿ‡ธ

Sylvania, Ohio, United States

Hospital Universitari Parc Tauli ( Site 0681)

๐Ÿ‡ช๐Ÿ‡ธ

Sabadell, Barcelona, Spain

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620)

๐Ÿ‡ต๐Ÿ‡ฑ

Lublin, Lubelskie, Poland

SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606)

๐Ÿ‡ต๐Ÿ‡ฑ

Olsztyn, Warminsko-mazurskie, Poland

University of Louisville ( Site 0059)

๐Ÿ‡บ๐Ÿ‡ธ

Louisville, Kentucky, United States

Smilow Cancer Hospital at Yale New Haven ( Site 0042)

๐Ÿ‡บ๐Ÿ‡ธ

New Haven, Connecticut, United States

James Graham Brown Cancer Center ( Site 0088)

๐Ÿ‡บ๐Ÿ‡ธ

Louisville, Kentucky, United States

Prince of Wales Hospital ( Site 0268)

๐Ÿ‡ญ๐Ÿ‡ฐ

Hong Kong, Hong Kong

Pamela Youde Nethersole Eastern Hospital ( Site 0271)

๐Ÿ‡ญ๐Ÿ‡ฐ

Hong Kong, Hong Kong

Tuen Mun Hospital ( Site 0272)

๐Ÿ‡ญ๐Ÿ‡ฐ

Tuen Mun, Hong Kong

Queen Mary Hospital ( Site 0267)

๐Ÿ‡ญ๐Ÿ‡ฐ

Hong Kong, Hong Kong

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