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NCT05904886Active, not recruitingPhase 3

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)

A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Brief summary (registry, in English)

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic HCC. Per amendment version 5, following a memo issued by the Sponsor, participants receiving treatment in the atezolizumab plus bevacizumab plus tiragolumab arm are recommended to discontinue tiragolumab treatment unless the investigator decides the benefit outweighs the risk. Participants receiving treatment in atezolizumab plus bevacizumab plus placebo arm must discontinue placebo treatment. Participants may continue receiving active treatment(s) per protocol until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
687 (actual)
First submitted
23 May 2023
Start date
14 Sept 2023
Primary completion date
8 May 2025
Lead sponsor
Hoffmann-La Roche
NCT number
NCT05904886
EU CT number
2023-503422-39-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 687
  • From 14 Sept 2023 to the primary completion date, 8 May 2025
  • 176 sites in 27 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
  • Treatment with systemic immunostimulatory agents
  • Treatment with systemic immunosuppressive medication
  • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment

Other illness

  • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Acute epstein-barr virus (EBV) infection or known or suspected chronic active EBV infection

Other

  • Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Who the study is looking for

  • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
  • Disease that is not amenable to curative surgical and/or locoregional therapies
  • No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC-measurable disease according to RECIST v1.1
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1 within 7 days prior to randomization
  • Child-pugh Class A within 7 days prior to randomization
  • Adequate hematologic and end-organ function
  • Female participants of childbearing potential must be willing to avoid pregnancy within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
  • Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab/placebo to avoid exposing the embryo.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (176)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Antwerp University Hospital
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EdegemBelgiumCompleted
AZ Delta
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RoeselareBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Hospital de Cancer de Barretos
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BarretosBrazilUnknown status
Oncoclínicas do Brasil - BELO HORIZONTE
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Belo HorizonteBrazilUnknown status
Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
Hospital Sao Lucas - PUCRS
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Porto AlegreBrazilUnknown status
Hospital do Cancer de Pernambuco - HCP
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RecifeBrazilUnknown status
Clinicas Oncologicas Integradas - COI
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Rio de JaneiroBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
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São PauloBrazilUnknown status
CEDOES - Diagnóstico e Pesquisa
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VitóriaBrazilUnknown status
Juravinski Hospital
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HamiltonCanadaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
McGill University Health Centre Glen Site
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MontrealCanadaUnknown status
Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
Centre National d'Oncologie Médicale et de Radiothérapie Alassane Ouattara (CNRAO)
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AbidjanCôte d’IvoireUnknown status
Polyclinique Internationale Sainte Anne- Marie (PISAM)
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AbidjanCôte d’IvoireUnknown status
Baoji Central Hospital
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BaojiChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Peoples Hospital of Hunan Province
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ChangshaChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Mengchao Hepatobiliary Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Nanfang Hospital, Southern Medical University
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GuangzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
The First Affiliated Hospital of College of Medicine,Zhejiang University
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
The Second Affiliated Hospital Of Anhui Medical University
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HefeiChinaUnknown status
Lishui Central Hospital
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LishuiChinaUnknown status
Zhongshan Hospital Fudan Unvierstiy
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ShanghaiChinaUnknown status
Renji Hospital, Shanghai Jiaotong University School of Medicine
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Tianjin Cancer Hospital
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TianjinChinaUnknown status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Xi'an Inernational Medical Center Hospital
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Xi'anChinaUnknown status
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Klinikum Esslingen GmbH
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Esslingen am NeckarGermanyCompleted
Universitaetsklinikum Magdeburg AöR
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MagdeburgGermanyCompleted
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
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MainzGermanyCompleted
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Universitario De Burgos
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BurgosSpainCompleted
Hospital Universitario de Jaén
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JaénSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Clínico San Carlos
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MadridSpainCompleted
Clinica Universidad de Navarra
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario Central De Asturias
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OviedoSpainCompleted
Hospital Universitario de Navarra
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PamplonaSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Centre Hospitalier Universitaire de Limoges
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LimogesFranceCompleted
Hôpital Saint Joseph
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MarseilleFranceCompleted
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceCompleted
Hospital Hotel Dieu
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NantesFranceCompleted
Hopital Saint Antoine
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Paris Cedex 12FranceCompleted
Centre Hospitalier Universitaire De Reims
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Reims CedexFranceCompleted
Centre Hospitalier Valence
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ValenceFranceCompleted
CHRU De Nancy
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Vandoeuvre Les NancyFranceCompleted
Hopital Paul Brousse
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Villejuif CedexFranceCompleted
Western General Hospital
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EdinburghUnited KingdomUnknown status
Royal Free Hospital
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LondonUnited KingdomUnknown status
Hammersmith Hospital
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LondonUnited KingdomUnknown status
Sweden Ghana Medical Center
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AccraGhanaUnknown status
KBTH
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AccraGhanaUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hosp
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ShatinHong Kong SAR ChinaUnknown status
IRCCS Ospedale Policlinico San Martino
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GenoaItalyCompleted
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
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PalermoItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Humanitas Research Hospital
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RozzanoItalyCompleted
Pia Fondazione Di Culto E Religione Card G Panico
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TricaseItalyCompleted
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyCompleted
Fujita Health University Hospital
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AichiJapanUnknown status
Chiba University Hospital
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ChibaJapanUnknown status
National Cancer Center Hospital East
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ChibaJapanUnknown status
Ehime Prefectural Central Hospital
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EhimeJapanUnknown status
Kurume University Hospital
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FukuokaJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Hokkaido University Hospital
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HokkaidoJapanUnknown status
Sapporo Kosei General Hospital
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HokkaidoJapanUnknown status
Kanazawa University Hospital
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IshikawaJapanUnknown status
Kanagawa Cancer Center
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KanagawaJapanUnknown status
Kitasato University hospital
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KanagawaJapanUnknown status
Toranomon Branch Hospital
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KanagawaJapanUnknown status
Kyoto University Hospital
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KyotoJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Iwate Medical University Hospital
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NumakunaiJapanUnknown status
The University of Osaka Hospital
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OsakaJapanUnknown status
Kindai University Hospital
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OsakaJapanUnknown status
Jichi Medical University Hospital
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TochigiJapanUnknown status
Japanese Red Cross Musashino Hospital
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TokyoJapanUnknown status
Toranomon Hospital
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TokyoJapanUnknown status
University of Nairobi - Institute of Tropical and Infectious Diseases
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NairobiKenyaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
CHA Bundang Medical Center
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Gyeonggi-doSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Ulsan University Hosiptal
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UlsanSouth KoreaUnknown status
Centro Medico Nacional Siglo Xxi - Imss
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Mexico CityMexicoUnknown status
Instituto Nacional de Ciencias Médicas Y de Nutricion Salvador Zubirán
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Mexico CityMexicoUnknown status
OncoMed
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Mexico CityMexicoUnknown status
Centro de Investigacion Clinica de Oaxaca
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Oaxaca CityMexicoUnknown status
Jos University Teaching Hospital
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JosNigeriaUnknown status
Lagos University Teaching Hospital Lagos (LUTH), Lagos State
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LagosNigeriaUnknown status
Auckland City Hospital
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AucklandNew ZealandUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Wellington Hospital
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WellingtonNew ZealandUnknown status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandCompleted
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandCompleted
ID Clinic
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MyslowicePolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
PanOncology Trials
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San JuanPuerto RicoUnknown status
National Cancer Centre
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SingaporeSingaporeUnknown status
Chulalongkorn Hospital
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BangkokThailandUnknown status
Ramathibodi Hospital
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BangkokThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital
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Chiang MaiThailandUnknown status
Khon Kaen Uni
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Khon KaenThailandUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Chi-Mei Medical Centre
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TainanTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan Uni Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation - Linkou
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TaoyuanTaiwanUnknown status
Uganda Cancer Institute
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KampalaUgandaUnknown status
Mercy Medical Center
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BaltimoreUnited StatesUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
UCSF Fresno at Community Cancer Institute
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ClovisUnited StatesUnknown status
North Texas VA Medical Center
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DallasUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
City of Hope Cancer Center
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DuarteUnited StatesUnknown status
Florida Cancer Specialists - Fort Myers (Broadway)
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Fort MyersUnited StatesUnknown status
Cancer & Hematology Centers of Western Michigan
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Grand RapidsUnited StatesUnknown status
Hartford Healthcare Cancer Institute at Hartford Hospital
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HartfordUnited StatesUnknown status
Genesis Cancer Center
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Hot SpringsUnited StatesUnknown status
Kelsey Seybold Clnic
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HoustonUnited StatesUnknown status
University of California San Diego Moores Cancer Center
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La JollaUnited StatesUnknown status
University of Southern California
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Los AngelesUnited StatesUnknown status
Norton Cancer Institute, Audubon
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LouisvilleUnited StatesUnknown status
Univ of Wisconsin-Madison
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MadisonUnited StatesUnknown status
Miami VA Healthcare System
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MiamiUnited StatesUnknown status
Ochsner Cancer Inst.
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New OrleansUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
NYU Langone
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
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New YorkUnited StatesUnknown status
Stanford Cancer Center
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Palo AltoUnited StatesUnknown status
VA Palo Alto Health Care System
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Palo AltoUnited StatesUnknown status
Thomas Jefferson Uni
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PhiladelphiaUnited StatesUnknown status
Mayo Clinic - Rochester
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RochesterUnited StatesUnknown status
UCLA Cancer Center
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Santa MonicaUnited StatesUnknown status
Virginia Mason Medical Center
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SeattleUnited StatesUnknown status
Swedish Cancer Inst.
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SeattleUnited StatesUnknown status
Washington Uni School of Medicine
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St LouisUnited StatesUnknown status
Florida Cancer Specialist, North Region
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St. PetersburgUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
James J Peters VA Hospital / Mental Illness Research Education and Clinic Center
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The BronxUnited StatesUnknown status
MedStar Washington Hosp Center
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Washington D.C.United StatesUnknown status
Minnesota Oncology Hematology Woodbury
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WoodburyUnited StatesUnknown status
Charlotte Maxeke Johannesburg Academic Hospital
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JohannesburgSouth AfricaUnknown status
Limpopo Cancer Research Institute
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PolokwaneSouth AfricaUnknown status
Adana Baskent University Medical Faculty
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AdanaTurkey (Türkiye)Unknown status
Gazi Uni Medical Faculty Hospital
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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EdirneTurkey (Türkiye)Unknown status
?zmir Medical Point
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Kar?iyakaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.