ClinicalTrials.gov

History of Changes for Study: NCT04770896
A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab (IMbrave251)
Latest version (submitted March 20, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 23, 2021 None (earliest Version on record)
2 March 22, 2021 Contacts/Locations, Study Status and Oversight
3 April 13, 2021 Study Status and Contacts/Locations
4 May 13, 2021 Recruitment Status, Contacts/Locations and Study Status
5 May 17, 2021 Contacts/Locations and Study Status
6 June 9, 2021 Contacts/Locations and Study Status
7 July 6, 2021 Contacts/Locations and Study Status
8 July 29, 2021 Contacts/Locations and Study Status
9 August 25, 2021 Contacts/Locations and Study Status
10 September 21, 2021 Contacts/Locations and Study Status
11 October 13, 2021 Contacts/Locations and Study Status
12 November 13, 2021 Contacts/Locations and Study Status
13 December 7, 2021 Contacts/Locations and Study Status
14 December 17, 2021 Contacts/Locations and Study Status
15 January 13, 2022 Study Status and Contacts/Locations
16 February 11, 2022 Contacts/Locations and Study Status
17 March 2, 2022 Contacts/Locations, Study Status, Eligibility, Outcome Measures and Study Description
18 March 28, 2022 Contacts/Locations and Study Status
19 April 18, 2022 Study Status and Contacts/Locations
20 May 17, 2022 Contacts/Locations and Study Status
21 June 14, 2022 Contacts/Locations and Study Status
22 July 8, 2022 Contacts/Locations and Study Status
23 July 29, 2022 Contacts/Locations and Study Status
24 August 1, 2022 Study Status and Eligibility
25 August 25, 2022 Contacts/Locations and Study Status
26 September 23, 2022 Study Status and Contacts/Locations
27 October 23, 2022 Contacts/Locations and Study Status
28 November 21, 2022 Contacts/Locations and Study Status
29 December 19, 2022 Contacts/Locations and Study Status
30 January 18, 2023 Contacts/Locations and Study Status
31 February 17, 2023 Contacts/Locations and Study Status
32 March 24, 2023 Contacts/Locations and Study Status
33 April 27, 2023 Study Status and Contacts/Locations
34 May 26, 2023 Contacts/Locations and Study Status
35 June 22, 2023 Contacts/Locations and Study Status
36 July 17, 2023 Contacts/Locations and Study Status
37 August 14, 2023 Contacts/Locations and Study Status
38 September 13, 2023 Contacts/Locations and Study Status
39 October 13, 2023 Contacts/Locations and Study Status
40 November 9, 2023 Contacts/Locations and Study Status
41 December 7, 2023 Study Status and Contacts/Locations
42 January 5, 2024 Contacts/Locations and Study Status
43 February 2, 2024 Contacts/Locations and Study Status
44 March 20, 2024 Contacts/Locations, Study Status and Outcome Measures
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Study NCT04770896
Submitted Date:  July 29, 2022 (v23)

Open or close this module Study Identification
Unique Protocol ID: MO42541
Brief Title: A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab (IMbrave251)
Official Title: A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2022
Overall Status: Recruiting
Study Start: April 26, 2021
Primary Completion: October 8, 2024 [Anticipated]
Study Completion: October 8, 2024 [Anticipated]
First Submitted: February 23, 2021
First Submitted that
Met QC Criteria:
February 23, 2021
First Posted: February 25, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
July 29, 2022
Last Update Posted: August 1, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.
Detailed Description:
Open or close this module Conditions
Conditions: Unresectable Hepatocellular Carcinoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 554 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Atezolizumab + Lenvatinib or Sorafenib
Participants will receive atezolizumab plus lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Other Names:
  • Tecentriq
Drug: Lenvatinib
Lenvatinib will be administered once daily by mouth each day of every 21-day study treatment cycle. Participants with a baseline body weight of < 60 kg will receive a daily dose of 8 mg. Participants with a baseline body weight of ≥ 60 kg will receive a daily dose of 12 mg.
Drug: Sorafenib
Sorafenib will be administered at a dose of 800 mg per day, i.e. two tablets of 200 mg swallowed by mouth twice daily (equivalent to a total daily dose of 800 mg) each day of every 21-day study treatment cycle.
Active Comparator: Lenvatinib or Sorafenib
Participants will receive lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Drug: Lenvatinib
Lenvatinib will be administered once daily by mouth each day of every 21-day study treatment cycle. Participants with a baseline body weight of < 60 kg will receive a daily dose of 8 mg. Participants with a baseline body weight of ≥ 60 kg will receive a daily dose of 12 mg.
Drug: Sorafenib
Sorafenib will be administered at a dose of 800 mg per day, i.e. two tablets of 200 mg swallowed by mouth twice daily (equivalent to a total daily dose of 800 mg) each day of every 21-day study treatment cycle.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: Randomization until death from any cause (approximately 42 months) ]

Overall survival (OS) is defined as the time from randomization into the study to death from any cause.
Secondary Outcome Measures:
1. Progression Free Survival (PFS)
[ Time Frame: Randomization until the first occurrence of disease progression or death from any cause whichever occurs first (approximately 42 months) ]

Progression free survival (PFS) is defined as the time from randomization into the study to the first occurrence of disease progression or death from any cause (whichever occurs first).
2. Confirmed Objective Response Rate (ORR)
[ Time Frame: Approximately 42 months ]

Confirmed Objective Response Rate (ORR) is defined as the proportion of patients with a best response of either complete or partial response.
3. Time to Progression (TTP)
[ Time Frame: Randomization until the first occurrence of disease progression (approximately 42 months) ]

Time to Progression (TTP) is defined as the time from randomization to the first occurrence of disease progression.
4. Duration of Response (DOR)
[ Time Frame: Time from the first occurrence of a confirmed documented objective response to disease progression or death from any cause whichever occurs first (approximately 42 months) ]

Duration of Response (DOR) is defined as the time from the first occurrence of a documented confirmed objective response to disease progression or death from any cause (whichever occurs first).
5. Time to deterioration (TTD)
[ Time Frame: Randomization to first deterioration maintained for two consecutive assessments, or one assessment followed by death from any cause wthin 3 weeks or 6 weeks (approximately 42 months) ]

Time to deterioration (TTD), of health-related quality of life (HRQoL), is defined as the time from randomization to first deterioration (decrease from baseline of ≥ 10 points) maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks (if Cycle 1-6) or 6 weeks (if after Cycle 6) in the following European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30(EORTC QLQC30) scales (separately): physical function, role function, and GHS/QoL.
6. Percentage of Participants With Adverse Events
[ Time Frame: Throughout study duration (approximately 42 months) ]

7. Percentage of Participants With Adverse Events for Combination Treatment, Adverse Events Related to Atezolizumab, and TKI-Related Adverse Events
[ Time Frame: Throughtout study (approximately 42 months) ]

8. Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
[ Time Frame: Throughout study (approximately 42 months) ]

9. Serum Concentration of Atezolizumab
[ Time Frame: At pre-defined intervals from first administration of study drug to approximately 42 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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 patients.
  • Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease (SD), partial response (PR), or complete response (CR).
  • At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) 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

Exclusion Criteria:

  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  • History of leptomeningeal disease
  • History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days
  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: MO42541 https://forpatients.roche.com/
Telephone: 888-662-6728 (U.S. and Canada)
Email: global.rochegenentechtrials@roche.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations: Austria
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
[Recruiting]
Salzburg, Austria, 5020
Belgium
AZ KLINA
[Active, not recruiting]
Brasschaat, Belgium, 2930
Cliniques Universitaires St-Luc
[Recruiting]
Bruxelles, Belgium, 1200
UZ Gent
[Recruiting]
Gent, Belgium, 9000
UZ Leuven
[Active, not recruiting]
Leuven, Belgium, 3000
Brazil, BA
Hospital Sao Rafael - HSR
[Recruiting]
Salvador, BA, Brazil, 41253-190
Brazil, DF
Sociedade beneficente de senhoras Hospital Sirio Libanes
[Recruiting]
Brasilia, DF, Brazil, 70200-730
Brazil, RJ
Clinicas Oncologicas Integradas - COI
[Recruiting]
Rio De Janeiro, RJ, Brazil, 22290-160
Brazil, RS
Hospital Sao Lucas - PUCRS
[Recruiting]
Porto Alegre, RS, Brazil, 90610-000
Brazil, SC
YNOVA Pesquisa Clinica
[Recruiting]
Florianopolis, SC, Brazil, 88020-210
Brazil, SP
Beneficencia Portuguesa de Sao Paulo
[Recruiting]
São Paulo, SP, Brazil, 01321-00
Canada, Alberta
Tom Baker Cancer Centre-Calgary
[Recruiting]
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
[Recruiting]
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Juravinski Cancer Centre
[Recruiting]
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Cancer Center
[Recruiting]
Toronto, Ontario, Canada, M5G 2M9
Chile
Centro de Estudios Clínicos SAGA
[Recruiting]
Santiago, Chile, 7500653
Hospital Clinico de La Universidad de Chile J.J.A.; Oncologia
[Recruiting]
Santiago, Chile, 8380456
Pontificia Universidad Catolica de Chile; Clinica San Carlos de Apoquindo
[Withdrawn]
Santiago, Chile
China
Peking University People's Hospital
[Recruiting]
Beijing, China, 100044
Sichuan Provincial Cancer Hospital
[Recruiting]
Chengdu, China, 610041
Fujian Provincial Hospital
[Recruiting]
Fuzhou City, China, 350001
Sun Yet-sen University Cancer Center
[Recruiting]
Guangzhou, China, 510060
Nanfang Hospital, Southern Medical University
[Recruiting]
Guangzhou, China, 510515
The First Affiliated Hospital, Sun Yat-sen University
[Recruiting]
Guangzhou City, China, 510080
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
[Recruiting]
Hangzhou, China, 310016
Harbin Medical University Cancer Hospital
[Recruiting]
Harbin, China, 150081
Anhui Province Cancer Hospital
[Recruiting]
Hefei, China, 230000
Shandong Provincial Hospital
[Recruiting]
Jinan, China, 250021
Shandong Cancer Hospital
[Recruiting]
Jinan, China, 250117
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
[Recruiting]
Nanjing City, China, 210029
Zhongshan Hospital Fudan University
[Recruiting]
Shanghai, China, 200032
Shengjing Hospital of China Medical University
[Recruiting]
ShenYang, China, 110004
Tianjin Cancer Hospital
[Recruiting]
Tianjin, China, 300060
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
[Recruiting]
Wuhan City, China, 430030
Costa Rica
Clinica CIMCA
[Recruiting]
San José, Costa Rica, 10103
ICIMED Instituto de Investigación en Ciencias Médicas
[Recruiting]
San José, Costa Rica, 10108
Croatia
Clinical Hospital Centre Zagreb
[Recruiting]
Zagreb, Croatia, 10000
Finland
Docrates Cance Center; Docrates
[Recruiting]
Helsinki, Finland, 00180
TAYS Radius rakennus; onkologinen lääketutkimusyksikkö
[Recruiting]
Tampere, Finland, 33521
Turku Uni Central Hospital; Oncology Clinics
[Recruiting]
Turku, Finland, 20520
France
CHRU de Lille - Hopital Claude Huriez
[Recruiting]
Lille, France, 59037
Aphm; Cpcet
[Recruiting]
Marseille, France, 13385
CH Saint Eloi
[Recruiting]
Montpellier, France, 34295
CHU de Nantes - Hotel Dieu
[Recruiting]
Nantes, France, 44093
CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie
[Recruiting]
Nice Cedex, France, 06202
APHP - Hopital Saint Antoine
[Recruiting]
Paris, France, 75571
CHU Bordeaux
[Recruiting]
Pessac, France, 33604
CHU de Toulouse - Hôpital Rangueil
[Recruiting]
Toulouse Cedex 09, France, 31059
Hopitaux de Brabois - Gastro-Entereologie
[Recruiting]
Vandoeuvre-les-nancy, France, 54511
Hopital Paul Brousse; Centre Hepatologie Biliaire
[Recruiting]
Villejuif, France, 94804
Germany
Klinikum Esslingen; Allg. Innere Med., Onkologie, Hämatologie, Gastroenterologie und Infektiologie
[Recruiting]
Esslingen, Germany, 73730
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
[Recruiting]
Frankfurt, Germany, 60590
Med. Hochschule Hannover; Gastroenterologie
[Recruiting]
Hannover, Germany, 30625
Uniklinik Mainz; I. Medizinische Klinik
[Recruiting]
Mainz, Germany, 55131
Universität Tübingen; Med. Klinik; Innere Medizin I
[Recruiting]
Tübingen, Germany, 72076
Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I
[Recruiting]
Ulm, Germany, 89081
Greece
Laiko General Hospital Athen; Uni Clinic of Gastrenterology
[Recruiting]
Athens, Greece, 115 27
Agioi Anargiroi Hospital of Kifissia; University Internal Medicine Clinic
[Recruiting]
Nea Kifissia, Greece, 14564
Anticancer Hospital of Thessaloniki " Theagenio"
[Recruiting]
Thessaloniki, Greece, 54007
Hippokratio Hospital; 4Th Internal Medicine Dpt
[Recruiting]
Thessaloniki, Greece, 546 42
Israel
Rambam Health Care Campus; Oncology
[Recruiting]
Haifa, Israel, 3109601
Rabin Medical Center; Oncology Dept
[Recruiting]
Petach Tikva, Israel, 4941492
Sourasky Medical Center; Oncology Department
[Recruiting]
Tel-Aviv, Israel, 6423900
Italy, Campania
Fondazione Pascale; U.O. Sperimentazioni Cliniche
[Recruiting]
Napoli, Campania, Italy, 80100
Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica
[Recruiting]
Napoli, Campania, Italy, 80131
Ospedale del Mare; UOC di Oncologia
[Recruiting]
Napoli, Campania, Italy, 80147
Italy, Emilia-Romagna
A.O. S. Orsola Malpighi; Ambulatorio Epatocarcinoma (Bolondi)
[Recruiting]
Bologna, Emilia-Romagna, Italy, 40138
Italy, Lazio
Azienda Ospedaliera San Camillo Forlanini
[Recruiting]
Roma, Lazio, Italy, 00152
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
[Recruiting]
Roma, Lazio, Italy, 00168
Italy, Lombardia
Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia
[Recruiting]
Milano, Lombardia, Italy, 20122
Italy, Piemonte
Azienda Ospedaliera Ordine Mauriziano di Torino
[Recruiting]
Torino, Piemonte, Italy, 10128
Italy, Sicilia
A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia
[Recruiting]
Palermo, Sicilia, Italy, 90127
Italy, Toscana
Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1
[Recruiting]
Firenze, Toscana, Italy, 50139
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2
[Recruiting]
Pisa, Toscana, Italy, 56100
Italy, Veneto
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
[Recruiting]
Padova, Veneto, Italy, 35128
Japan
Chiba University Hospital
[Recruiting]
Chiba, Japan, 260-8677
National Cancer Center Hospital East
[Recruiting]
Chiba, Japan, 277-8577
Yokohama City University Medical Center
[Recruiting]
Kanagawa, Japan, 232-0024
Kindai University Hospital
[Recruiting]
Osaka, Japan, 589-8511
Toranomon Hospital
[Recruiting]
Tokyo, Japan, 105-8470
Korea, Republic of
National Cancer Center
[Recruiting]
Goyang-si, Korea, Republic of, 10408
CHA Bundang Medical Center
[Active, not recruiting]
Gyeonggi-do, Korea, Republic of, 13496
Severance Hospital, Yonsei University Health System
[Recruiting]
Seoul, Korea, Republic of, 03722
Samsung Medical Center
[Recruiting]
Seoul, Korea, Republic of, 06351
Malaysia
Uni Malaya Medical Center; Clinical Oncology Unit, Menara Timur
[Recruiting]
Kuala Lumpur, Malaysia, 59100
Malaysia, FED. Territory OF Kuala Lumpur
Institute Kanser Negara (IKN)
[Recruiting]
Putrajaya, FED. Territory OF Kuala Lumpur, Malaysia, 62250
Malaysia, Selangor
Beacon International Specialist Centre; Clinical Research Department, Level 2
[Recruiting]
Petaling Jaya, Selangor, Selangor, Malaysia, 46050
Philippines
Makati Medical Center
[Recruiting]
Makati City, Philippines, 1229
Russian Federation
FSBI "National Medical Research Center of Oncology N.N. Blokhin"
[Recruiting]
Moscow, Russian Federation, 115478
Russian Federation, Moskovskaja Oblast
Moscow City Oncology Hospital #62; Outpatient Care Center
[Recruiting]
Moscow, Moskovskaja Oblast, Russian Federation, 125134
Group of companies "Medci"
[Recruiting]
Moskva, Moskovskaja Oblast, Russian Federation, 105229
I.M.Sechenov First Moscow State Medical University (1st MSMU)
[Recruiting]
Moskva, Moskovskaja Oblast, Russian Federation, 119991
Clinical Hospital Lapino (LLC Haven)
[Recruiting]
Yudino, Moskovskaja Oblast, Russian Federation, 143081
Russian Federation, Sankt Petersburg
LLC "Oncology scientific centre"
[Recruiting]
Pesochny, Sankt Petersburg, Russian Federation, 197758
Slovenia
University Medical Center Ljubljana; Clinical Dept. of Gastroenterology
[Recruiting]
Ljubljana, Slovenia, 1000
Spain
Hospital Universitari Vall d'Hebron; Servicio de Hepatologia
[Recruiting]
Barcelona, Spain, 08035
Hospital Universitario Reina Sofia; Servicio de Hepatologia
[Recruiting]
Cordoba, Spain, 14004
Clinica Universidad de Navarra Madrid; Servicio de Oncología
[Recruiting]
Madrid, Spain, 28027
Hospital Clinico San Carlos; Servicio de Oncologia
[Recruiting]
Madrid, Spain, 28040
START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
[Recruiting]
Madrid, Spain, 28050
Hospital Universitario la Fe; Servicio de Oncologia
[Active, not recruiting]
Valencia, Spain, 46026
Hospital Universitario Miguel Servet; Servicio Oncologia
[Recruiting]
Zaragoza, Spain, 50009
Spain, Barcelona
Corporacio Sanitaria Parc Tauli; Servicio de Hepatologia
[Recruiting]
Sabadell, Barcelona, Spain, 08208
Spain, Islas Baleares
Hospital Son Llatzer; Servicio de Oncologia
[Recruiting]
Palma de Mallorca, Islas Baleares, Spain, 07198
Spain, LA Coruña
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
[Recruiting]
Santiago de Compostela, LA Coruña, Spain, 15706
Spain, Navarra
Clinica Universitaria de Navarra; Servicio de Hepatologia
[Recruiting]
Pamplona/iruña, Navarra, Spain, 31008
Switzerland
Inselspital Bern Medizin Gastroenterologie
[Recruiting]
Bern, Switzerland, 3010
Universitätsspital Zürich Medizin Gastroenterologie; Klinik für Gastroenterologie und Hepatologie
[Recruiting]
Zürich, Switzerland, 8091
Taiwan
Chi-Mei Medical Centre; Hematology & Oncology
[Recruiting]
Tainan, Taiwan, 710
National Taiwan University Hospital; Oncology
[Recruiting]
Zhongzheng Dist., Taiwan, 10048
Thailand
Chulalongkorn Hospital; Medical Oncology
[Active, not recruiting]
Bangkok, Thailand, 10330
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
[Recruiting]
Bangkok, Thailand, 10700
Turkey
Adana Acıbadem Hospital Oncology Department
[Active, not recruiting]
Adana, Turkey, 01130
Memorial Ankara Hastanesi
[Recruiting]
Ankara, Turkey, 06520
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
[Recruiting]
Bakirkoy / Istanbul, Turkey, 34147
Uludag Uni Hospital; Oncology
[Recruiting]
Bursa, Turkey, 16059
Medipol Mega Üniversite Hastanesi Göztepe
[Recruiting]
Istanbul, Turkey, 34214
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
[Recruiting]
Sihhiye/Ankara, Turkey, 06230
Acıbadem Altunizade Hastanesi; Oncology
[Active, not recruiting]
Üsküdar, Turkey, 34662
United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
[Recruiting]
Liverpool, United Kingdom, L7 8YA
Royal Free Hospital
[Recruiting]
London, United Kingdom, NW3 2QS
King College Hospital NHS Foundation Trust
[Recruiting]
London, United Kingdom, SE5 9RS
Hammersmith Hospital; Clinical trials unit
[Recruiting]
London, United Kingdom, W12 0HS
Christie Hospital Nhs Trust; Medical Oncology
[Recruiting]
Manchester, United Kingdom, M2O 4BX
Churchill Hospital; Department of Oncology
[Recruiting]
Oxford, United Kingdom, OX3 7LE
Open or close this module IPDSharing
Plan to Share IPD: Yes
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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