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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06047080




Registration number
NCT06047080
Ethics application status
Date submitted
14/09/2023
Date registered
21/09/2023

Titles & IDs
Public title
An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma
Scientific title
A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma
Secondary ID [1] 0 0
GO44145
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Large B-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Glofitamab
Treatment: Drugs - Polatuzumab vedotin
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Prednisone

Experimental: Glofitamab + Pola-R-CHP - Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).

Active comparator: Pola-R-CHP - Participants will receive Pola-R-CHP.


Treatment: Drugs: Glofitamab
Participants will receive intravenous (IV) glofitamab

Treatment: Drugs: Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin in combination with R-CHP

Treatment: Drugs: Rituximab
Participants will receive IV rituximab

Treatment: Drugs: Cyclophosphamide
Participants will receive cyclophosphamide as part of CHP chemotherapy

Treatment: Drugs: Doxorubicin
Participants will receive IV doxorubicin

Treatment: Drugs: Prednisone
Participants will receive oral prednisone as part of CHP chemotherapy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) as determined by Independent Review Facility (IRF)
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months)
Secondary outcome [1] 0 0
PFS as determined by the investigator
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 65 months)
Secondary outcome [2] 0 0
PFS as determined by the investigator and IRF for participants with international prognostic index (IPI) 3-5
Timepoint [2] 0 0
From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to 65 months)
Secondary outcome [3] 0 0
Event-free survival efficacy causes (EFSeff)
Timepoint [3] 0 0
From randomization to the earliest occurrence of disease progression or relapse; death due to any cause; initiation of new anti-lymphoma treatment; or positive biopsy for residual disease after treatment completion (up to approximately 65 months)
Secondary outcome [4] 0 0
Complete response (CR) rate
Timepoint [4] 0 0
At the end of treatment (up to approximately 65 months)
Secondary outcome [5] 0 0
Objective response rate (ORR)
Timepoint [5] 0 0
At treatment completion or discontinuation (up to approximately 65 months)
Secondary outcome [6] 0 0
Overall survival (OS)
Timepoint [6] 0 0
From randomization to death from any cause (up to approximately 65 months)
Secondary outcome [7] 0 0
Duration of response (DOR)
Timepoint [7] 0 0
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 65 months)
Secondary outcome [8] 0 0
Duration of complete response (DOCR)
Timepoint [8] 0 0
From the first occurrence of a documented complete response (CR) to disease progression or death, whichever occurs first (up to approximately 65 months)
Secondary outcome [9] 0 0
Disease-free survival (DFS)
Timepoint [9] 0 0
From a documented CR at the end of treatment to disease progression or death, whichever occurs first (up to approximately 65 months)
Secondary outcome [10] 0 0
Serum concentration of glofitamab
Timepoint [10] 0 0
Up to approximately 65 months
Secondary outcome [11] 0 0
Incidence of anti-drug antibodies (ADAs)
Timepoint [11] 0 0
Baseline up to approximately 65 months
Secondary outcome [12] 0 0
Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
Timepoint [12] 0 0
Up to approximately 65 months
Secondary outcome [13] 0 0
Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)
Timepoint [13] 0 0
Up to approximately 65 months
Secondary outcome [14] 0 0
Percentage of Participants with Adverse Events (AEs)
Timepoint [14] 0 0
From randomization to the end of study (up to approximately 65 months)

Eligibility
Key inclusion criteria
* Previously untreated participants with CD20-positive LBCL
* Ability to provide tumor tissue
* International prognostic index (IPI) score 2-5
* Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
* At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI
* Left ventricular ejection fraction (LVEF) >/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
* Adequate hematologic function
* Negative HIV test at screening with exceptions as defined by the protocol
* Negative SARS-CoV-2 antigen or PCR test
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
* Prior solid organ transplantation
* Participants receiving systemic immunosuppressive agent such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 4 weeks prior to first dose of study treatment
* Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
* History of indolent lymphoma (e.g., Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom macroglobulinemia)
* Current diagnosis of the following: Follicular lymphoma grade 3B; transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma); mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; primary large B-cell lymphoma of immune-privileged sites (encompassing primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina and primary large B-cell lymphoma of the testis); primary effusion DLBCL; and primary cutaneous DLBCL, leg type
* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
* Prior treatment with systemic immunotherapeutic agents
* Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
* Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
* Prior radiotherapy to the mediastinal/pericardial region
* Prior therapy for LBCL, with the exception of corticosteriods
* Corticosteroid use > 50 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Significant or extensive history of cardiovascular disease
* Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Known or suspected chronic active Epstein-Barr viral infection
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Active autoimmune disease which is not well controlled by therapy
* Clinically significant liver disease
* Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover are prohibited
* Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
* Suspected active or latent tuberculosis
* Positive test results for chronic hepatitis B infection, hepatitis C, or the human T-lymphotropic virus type 1 (HTLV-1)
* History of progressive multifocal leukoencephalopathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2029
Actual
Sample size
Target
1130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Prince of Wales Hospital- Department of Hematology - Randwick
Recruitment hospital [3] 0 0
Townsville Hospital; Haematology and Oncology - Douglas
Recruitment hospital [4] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [5] 0 0
Flinders Medical Centre; Dept of Haematology - Bedford Park
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
Eastern Health - Box Hill
Recruitment hospital [8] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [9] 0 0
Barwon Health - Geelong
Recruitment hospital [10] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [11] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4812 - Douglas
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
- Box Hill
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Montana
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Dakota
Country [14] 0 0
United States of America
State/province [14] 0 0
Vermont
Country [15] 0 0
United States of America
State/province [15] 0 0
West Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Argentina
State/province [17] 0 0
Buenos Aires
Country [18] 0 0
Argentina
State/province [18] 0 0
Cordoba
Country [19] 0 0
Argentina
State/province [19] 0 0
Pilar
Country [20] 0 0
Belgium
State/province [20] 0 0
Anderlecht
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussel
Country [22] 0 0
Belgium
State/province [22] 0 0
Edegem
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
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Kortrijk
Country [25] 0 0
Belgium
State/province [25] 0 0
Liège
Country [26] 0 0
Brazil
State/province [26] 0 0
PR
Country [27] 0 0
Brazil
State/province [27] 0 0
SP
Country [28] 0 0
Canada
State/province [28] 0 0
British Columbia
Country [29] 0 0
Canada
State/province [29] 0 0
Nova Scotia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
China
State/province [32] 0 0
Beijing
Country [33] 0 0
China
State/province [33] 0 0
Changchun City
Country [34] 0 0
China
State/province [34] 0 0
Changsha CITY
Country [35] 0 0
China
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Chengdu
Country [36] 0 0
China
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Chongqing
Country [37] 0 0
China
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Fuzhou
Country [38] 0 0
China
State/province [38] 0 0
Guangdong Province Guangzhou City
Country [39] 0 0
China
State/province [39] 0 0
Guangzhou
Country [40] 0 0
China
State/province [40] 0 0
Harbin
Country [41] 0 0
China
State/province [41] 0 0
Hefei City
Country [42] 0 0
China
State/province [42] 0 0
Jinan
Country [43] 0 0
China
State/province [43] 0 0
Nanchang City
Country [44] 0 0
China
State/province [44] 0 0
Nanjing City
Country [45] 0 0
China
State/province [45] 0 0
Nanning City
Country [46] 0 0
China
State/province [46] 0 0
Shanghai City
Country [47] 0 0
China
State/province [47] 0 0
Shenyang City
Country [48] 0 0
China
State/province [48] 0 0
Shenyang
Country [49] 0 0
China
State/province [49] 0 0
Suzhou
Country [50] 0 0
China
State/province [50] 0 0
Tianjin City
Country [51] 0 0
China
State/province [51] 0 0
Tianjin
Country [52] 0 0
China
State/province [52] 0 0
Wuhan City
Country [53] 0 0
China
State/province [53] 0 0
Xi'an
Country [54] 0 0
China
State/province [54] 0 0
Xiamen
Country [55] 0 0
China
State/province [55] 0 0
Zhengzhou
Country [56] 0 0
Denmark
State/province [56] 0 0
Aalborg
Country [57] 0 0
Denmark
State/province [57] 0 0
Aarhus N
Country [58] 0 0
Denmark
State/province [58] 0 0
Herning
Country [59] 0 0
France
State/province [59] 0 0
Lille
Country [60] 0 0
France
State/province [60] 0 0
Lyon
Country [61] 0 0
France
State/province [61] 0 0
Marseille
Country [62] 0 0
France
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Montpellier
Country [63] 0 0
France
State/province [63] 0 0
Nantes
Country [64] 0 0
France
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Pessac
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France
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Rennes
Country [66] 0 0
France
State/province [66] 0 0
Rouen
Country [67] 0 0
France
State/province [67] 0 0
Strasbourg
Country [68] 0 0
France
State/province [68] 0 0
Toulouse
Country [69] 0 0
Germany
State/province [69] 0 0
Berlin
Country [70] 0 0
Germany
State/province [70] 0 0
Brandenburg an der Havel
Country [71] 0 0
Germany
State/province [71] 0 0
Chemnitz
Country [72] 0 0
Germany
State/province [72] 0 0
Düsseldorf
Country [73] 0 0
Germany
State/province [73] 0 0
Erlangen
Country [74] 0 0
Germany
State/province [74] 0 0
Essen
Country [75] 0 0
Germany
State/province [75] 0 0
Frankfurt
Country [76] 0 0
Germany
State/province [76] 0 0
Hamburg
Country [77] 0 0
Germany
State/province [77] 0 0
Kaiserslautern
Country [78] 0 0
Germany
State/province [78] 0 0
Kiel
Country [79] 0 0
Germany
State/province [79] 0 0
Koeln
Country [80] 0 0
Germany
State/province [80] 0 0
Luebeck
Country [81] 0 0
Germany
State/province [81] 0 0
Magdeburg
Country [82] 0 0
Germany
State/province [82] 0 0
München
Country [83] 0 0
Germany
State/province [83] 0 0
Münster
Country [84] 0 0
Germany
State/province [84] 0 0
Potsdam
Country [85] 0 0
Germany
State/province [85] 0 0
Rostock
Country [86] 0 0
Germany
State/province [86] 0 0
Stuttgart
Country [87] 0 0
Germany
State/province [87] 0 0
Ulm
Country [88] 0 0
Germany
State/province [88] 0 0
Würzburg
Country [89] 0 0
Italy
State/province [89] 0 0
Campania
Country [90] 0 0
Italy
State/province [90] 0 0
Emilia-Romagna
Country [91] 0 0
Italy
State/province [91] 0 0
Liguria
Country [92] 0 0
Italy
State/province [92] 0 0
Lombardia
Country [93] 0 0
Italy
State/province [93] 0 0
Sicilia
Country [94] 0 0
Italy
State/province [94] 0 0
Toscana
Country [95] 0 0
Italy
State/province [95] 0 0
Veneto
Country [96] 0 0
Japan
State/province [96] 0 0
Aichi
Country [97] 0 0
Japan
State/province [97] 0 0
Chiba
Country [98] 0 0
Japan
State/province [98] 0 0
Fukuoka
Country [99] 0 0
Japan
State/province [99] 0 0
Gifu
Country [100] 0 0
Japan
State/province [100] 0 0
Hokkaido
Country [101] 0 0
Japan
State/province [101] 0 0
Hyogo
Country [102] 0 0
Japan
State/province [102] 0 0
Kanagawa
Country [103] 0 0
Japan
State/province [103] 0 0
Kyoto
Country [104] 0 0
Japan
State/province [104] 0 0
Miyagi
Country [105] 0 0
Japan
State/province [105] 0 0
Okayama
Country [106] 0 0
Japan
State/province [106] 0 0
Osaka
Country [107] 0 0
Japan
State/province [107] 0 0
Tokyo
Country [108] 0 0
Japan
State/province [108] 0 0
Yamagata
Country [109] 0 0
Korea, Republic of
State/province [109] 0 0
Busan
Country [110] 0 0
Korea, Republic of
State/province [110] 0 0
Daegu
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Daejeon
Country [112] 0 0
Korea, Republic of
State/province [112] 0 0
Goyang-si
Country [113] 0 0
Korea, Republic of
State/province [113] 0 0
Jeollanam-do
Country [114] 0 0
Korea, Republic of
State/province [114] 0 0
Seoul
Country [115] 0 0
Mexico
State/province [115] 0 0
Mexico CITY (federal District)
Country [116] 0 0
Mexico
State/province [116] 0 0
Tlaxcala
Country [117] 0 0
Poland
State/province [117] 0 0
Brzozów
Country [118] 0 0
Poland
State/province [118] 0 0
Gda?sk
Country [119] 0 0
Poland
State/province [119] 0 0
Katowice
Country [120] 0 0
Poland
State/province [120] 0 0
Kielce
Country [121] 0 0
Poland
State/province [121] 0 0
Kraków
Country [122] 0 0
Poland
State/province [122] 0 0
Wroc?aw
Country [123] 0 0
Spain
State/province [123] 0 0
LA Coruña
Country [124] 0 0
Spain
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Madrid
Country [125] 0 0
Spain
State/province [125] 0 0
Navarra
Country [126] 0 0
Spain
State/province [126] 0 0
Barcelona
Country [127] 0 0
Spain
State/province [127] 0 0
Sevilla
Country [128] 0 0
Spain
State/province [128] 0 0
Valencia
Country [129] 0 0
Switzerland
State/province [129] 0 0
Basel
Country [130] 0 0
Taiwan
State/province [130] 0 0
Chai Yi
Country [131] 0 0
Taiwan
State/province [131] 0 0
Kaoisung
Country [132] 0 0
Taiwan
State/province [132] 0 0
Kaoshiung
Country [133] 0 0
Taiwan
State/province [133] 0 0
Taichung
Country [134] 0 0
Taiwan
State/province [134] 0 0
Tainan
Country [135] 0 0
Taiwan
State/province [135] 0 0
Taipei
Country [136] 0 0
Turkey
State/province [136] 0 0
Ankara
Country [137] 0 0
Turkey
State/province [137] 0 0
Istanbul
Country [138] 0 0
Turkey
State/province [138] 0 0
Izmit
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Barnet
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Blackpool
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Canterbury
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Exeter
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Glasgow
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Leeds
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Leicester
Country [146] 0 0
United Kingdom
State/province [146] 0 0
London
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Newcastle
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Nottingham
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Oxford
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO44145 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06047080