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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05277051




Registration number
NCT05277051
Ethics application status
Date submitted
3/03/2022
Date registered
14/03/2022

Titles & IDs
Public title
First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors
Scientific title
A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors
Secondary ID [1] 0 0
2023-509414-11
Secondary ID [2] 0 0
217228
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK4381562
Treatment: Drugs - Dostarlimab
Treatment: Drugs - Belrestotug
Treatment: Drugs - Nelistotug
Treatment: Drugs - GSK5764227

Experimental: Participants receiving GSK4381562 monotherapy (Arm A) -

Experimental: Participants receiving GSK4381562 plus dostarlimab (Arm B) -

Experimental: Participants receiving GSK4381562 plus dostarlimab plus belrestotug (Arm C) -

Experimental: Participants receiving dostarlimab plus belrestotug (Arm D) -

Experimental: Participants receiving dostarlimab plus belrestotug plus GSK4381562 (Arm E) -

Experimental: Participants receiving dostarlimab plus belrestotug plus nelistotug (Arm F) -

Experimental: China Cohort: Participants receiving dostarlimab (Arm G) -

Experimental: China Cohort: Participants receiving dostarlimab plus belrestotug (Arm H) -

Experimental: Participants receiving GSK5764227 plus dostarlimab (Arm I) -


Treatment: Drugs: GSK4381562
GSK4381562 will be administered.

Treatment: Drugs: Dostarlimab
Dostarlimab will be administered.

Treatment: Drugs: Belrestotug
Belrestotug will be administered.

Treatment: Drugs: Nelistotug
Nelistotug will be administered.

Treatment: Drugs: GSK5764227
GSK5764227 will be administered.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Arms A, B, C, I: Number of Participants with dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 21 days
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 27 months
Secondary outcome [1] 0 0
Number of Participants With Clinically Significant Changes in Laboratory Parameters, Electrocardiogram (ECG) and Vital Signs
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Number of Participants With Dose Reductions or Delays
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Number of Participants With Withdrawals due to AEs
Timepoint [3] 0 0
Up to 27 months
Secondary outcome [4] 0 0
Overall Response Rate (ORR)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Number of Participants With Positive Antidrug Antibodies (ADA) to GSK4381562
Timepoint [5] 0 0
Up to 27 months
Secondary outcome [6] 0 0
Titres of ADA to GSK4381562
Timepoint [6] 0 0
Up to 27 months
Secondary outcome [7] 0 0
Number of Participants With Positive ADA to Dostarlimab
Timepoint [7] 0 0
Up to 27 months
Secondary outcome [8] 0 0
Titers of ADA to Dostarlimab
Timepoint [8] 0 0
Up to 27 months
Secondary outcome [9] 0 0
Number of Participants With Positive ADA to belrestotug
Timepoint [9] 0 0
Up to 27 months
Secondary outcome [10] 0 0
Titers of ADA to belrestotug
Timepoint [10] 0 0
Up to 27 months
Secondary outcome [11] 0 0
Number of Participants With Positive ADA to nelistotug
Timepoint [11] 0 0
Up to 27 months
Secondary outcome [12] 0 0
Titers of ADA to nelistotug
Timepoint [12] 0 0
Up to 27 months
Secondary outcome [13] 0 0
Number of Participants With Positive ADA to GSK5764227
Timepoint [13] 0 0
Up to 27 months
Secondary outcome [14] 0 0
Titers of ADA to GSK5764227
Timepoint [14] 0 0
Up to 27 months
Secondary outcome [15] 0 0
Serum Concentrations of GSK4381562
Timepoint [15] 0 0
Up to 4 months
Secondary outcome [16] 0 0
Serum Concentrations of dostarlimab
Timepoint [16] 0 0
Up to 4 months
Secondary outcome [17] 0 0
Serum Concentrations of belrestotug
Timepoint [17] 0 0
Up to 4 months
Secondary outcome [18] 0 0
Serum Concentrations of nelistotug
Timepoint [18] 0 0
Up to 4 months
Secondary outcome [19] 0 0
Serum Concentrations of GSK5764227
Timepoint [19] 0 0
Up to 4 months
Secondary outcome [20] 0 0
Maximum Observed Plasma Concentration (Cmax) of GSK4381562 Monotherapy
Timepoint [20] 0 0
Up to 27 months
Secondary outcome [21] 0 0
Cmax of GSK4381562 in Combination With Dostarlimab
Timepoint [21] 0 0
Up to 27 months
Secondary outcome [22] 0 0
Cmax of GSK4381562 in Combination With dostarlimab and belrestotug
Timepoint [22] 0 0
Up to 27 months
Secondary outcome [23] 0 0
Cmax following administration of dostarlimab with belrestotug
Timepoint [23] 0 0
Up to 27 months
Secondary outcome [24] 0 0
Minimum Observed Plasma Concentration (Cmin) of GSK4381562 Monotherapy
Timepoint [24] 0 0
Up to 27 months
Secondary outcome [25] 0 0
Cmin of GSK4381562 in Combination With Dostarlimab
Timepoint [25] 0 0
Up to 27 months
Secondary outcome [26] 0 0
Cmin of GSK4381562 in Combination With dostarlimab and belrestotug
Timepoint [26] 0 0
Up to 27 months
Secondary outcome [27] 0 0
Cmin following administration of dostarlimab with belrestotug
Timepoint [27] 0 0
Up to 27 months
Secondary outcome [28] 0 0
Area Under the Plasma Concentration Curve From Time Zero to Last Time of Quantifiable Concentration (AUC[0-t]) of GSK4381562
Timepoint [28] 0 0
Up to 27 months
Secondary outcome [29] 0 0
AUC(0-t) of GSK4381562 in Combination With Dostarlimab
Timepoint [29] 0 0
Up to 27 months
Secondary outcome [30] 0 0
AUC(0-t) of GSK4381562 in Combination With dostarlimab and belrestotug
Timepoint [30] 0 0
Up to 27 months
Secondary outcome [31] 0 0
AUC(0-t) following administration of dostarlimab with belrestotug
Timepoint [31] 0 0
Up to 27 months
Secondary outcome [32] 0 0
AUC From Time Zero to Infinity (AUC[0-infinity]) of Single Dosing of GSK4381562
Timepoint [32] 0 0
Up to 27 months
Secondary outcome [33] 0 0
AUC(0-infinity) of Single Dosing of GSK4381562 in Combination with Dostarlimab
Timepoint [33] 0 0
Up to 27 months
Secondary outcome [34] 0 0
AUC(0-infinity) of Single Dosing of GSK4381562 in Combination With dostarlimab and belrestotug
Timepoint [34] 0 0
Up to 27 months
Secondary outcome [35] 0 0
AUC(0-infinity) following administration of dostarlimab with belrestotug
Timepoint [35] 0 0
Up to 27 months
Secondary outcome [36] 0 0
Cmax of dostarlimab in Combination With GSK4381562
Timepoint [36] 0 0
Up to 27 months
Secondary outcome [37] 0 0
Cmax of dostarlimab in combination with GSK5764227
Timepoint [37] 0 0
Up to 27 months
Secondary outcome [38] 0 0
Cmax of dostarlimab in combination with GSK4381562 followed by belrestotug
Timepoint [38] 0 0
Up to 27 months
Secondary outcome [39] 0 0
Cmax of dostarlimab in combination with belrestotug
Timepoint [39] 0 0
Up to 27 months
Secondary outcome [40] 0 0
Cmax of dostarlimab in combination with belrestotug and GSK4381562
Timepoint [40] 0 0
Up to 27 months
Secondary outcome [41] 0 0
Cmax of dostarlimab in combination with belrestotug and nelistotug
Timepoint [41] 0 0
Up to 27 months
Secondary outcome [42] 0 0
China cohort: Cmax of dostarlimab monotherapy
Timepoint [42] 0 0
Up to 27 months
Secondary outcome [43] 0 0
China cohort: Cmax of dostarlimab in combination with belrestotug
Timepoint [43] 0 0
Up to 27 months
Secondary outcome [44] 0 0
Cmin of dostarlimab in Combination With GSK4381562
Timepoint [44] 0 0
Up to 27 months
Secondary outcome [45] 0 0
Cmin of dostarlimab in combination with GSK5764227
Timepoint [45] 0 0
Up to 27 months
Secondary outcome [46] 0 0
Cmin of dostarlimab in combination with GSK4381562 followed by belrestotug
Timepoint [46] 0 0
Up to 27 months
Secondary outcome [47] 0 0
Cmin of dostarlimab in combination with belrestotug
Timepoint [47] 0 0
Up to 27 months
Secondary outcome [48] 0 0
Cmin of dostarlimab in combination with belrestotug and GSK4381562
Timepoint [48] 0 0
Up to 27 months
Secondary outcome [49] 0 0
Cmin of dostarlimab in combination with belrestotug and nelistotug
Timepoint [49] 0 0
Up to 27 months
Secondary outcome [50] 0 0
China cohort: Cmin of dostarlimab monotherapy
Timepoint [50] 0 0
Up to 27 months
Secondary outcome [51] 0 0
China cohort: Cmin of dostarlimab in combination with belrestotug
Timepoint [51] 0 0
Up to 27 months
Secondary outcome [52] 0 0
AUC(0-t) of dostarlimab in Combination With GSK4381562
Timepoint [52] 0 0
Up to 27 months
Secondary outcome [53] 0 0
AUC(0-t) of dostarlimab in combination with GSK5764227
Timepoint [53] 0 0
Up to 27 months
Secondary outcome [54] 0 0
AUC(0-t) of dostarlimab in combination with GSK4381562 followed by belrestotug
Timepoint [54] 0 0
Up to 27 months
Secondary outcome [55] 0 0
AUC(0-t) of dostarlimab in combination with belrestotug
Timepoint [55] 0 0
Up to 27 months
Secondary outcome [56] 0 0
AUC(0-t) of dostarlimab in combination with belrestotug and GSK4381562
Timepoint [56] 0 0
Up to 27 months
Secondary outcome [57] 0 0
AUC(0-t) of dostarlimab in combination with belrestotug and nelistotug
Timepoint [57] 0 0
Up to 27 months
Secondary outcome [58] 0 0
China cohort: AUC(0-t) of dostarlimab monotherapy
Timepoint [58] 0 0
Up to 27 months
Secondary outcome [59] 0 0
China cohort: AUC(0-t) of dostarlimab in combination with belrestotug
Timepoint [59] 0 0
Up to 27 months
Secondary outcome [60] 0 0
AUC(0-infinity) of dostarlimab in Combination With GSK4381562
Timepoint [60] 0 0
Up to 27 months
Secondary outcome [61] 0 0
AUC(0-infinity) of dostarlimab in combination with GSK5764227
Timepoint [61] 0 0
Up to 27 months
Secondary outcome [62] 0 0
AUC(0-infinity) of dostarlimab in combination with GSK4381562 followed by belrestotug
Timepoint [62] 0 0
Up to 27 months
Secondary outcome [63] 0 0
AUC(0-infinity) of dostarlimab in combination with belrestotug
Timepoint [63] 0 0
Up to 27 months
Secondary outcome [64] 0 0
AUC(0-infinity) of dostarlimab in combination with belrestotug and GSK4381562
Timepoint [64] 0 0
Up to 27 months
Secondary outcome [65] 0 0
AUC(0-infinity) of dostarlimab in combination with belrestotug and nelistotug
Timepoint [65] 0 0
Up to 27 months
Secondary outcome [66] 0 0
China cohort: AUC(0-infinity) of dostarlimab monotherapy
Timepoint [66] 0 0
Up to 27 months
Secondary outcome [67] 0 0
China cohort: AUC(0-infinity) of dostarlimab in combination with belrestotug
Timepoint [67] 0 0
Up to 27 months
Secondary outcome [68] 0 0
Mean terminal half-life (t1/2) of dostarlimab in Combination With GSK4381562
Timepoint [68] 0 0
Up to 27 months
Secondary outcome [69] 0 0
Mean terminal half-life (t1/2) of dostarlimab in combination with GSK5764227
Timepoint [69] 0 0
Up to 27 months
Secondary outcome [70] 0 0
China cohort: t1/2 of dostarlimab monotherapy
Timepoint [70] 0 0
Up to 27 months
Secondary outcome [71] 0 0
China cohort: t1/2 of dostarlimab in combination with belrestotug
Timepoint [71] 0 0
Up to 27 months
Secondary outcome [72] 0 0
Cmax of belrestotug in combination with dostarlimab followed by GSK4381562
Timepoint [72] 0 0
Up to 27 months
Secondary outcome [73] 0 0
Cmax of belrestotug in combination with dostarlimab
Timepoint [73] 0 0
Up to 27 months
Secondary outcome [74] 0 0
Cmax of belrestotug in combination with dostarlimab and GSK4381562
Timepoint [74] 0 0
Up to 27 months
Secondary outcome [75] 0 0
Cmax of belrestotug in combination with dostarlimab and nelistotug
Timepoint [75] 0 0
Up to 27 months
Secondary outcome [76] 0 0
China cohort: Cmax of belrestotug in combination with dostarlimab
Timepoint [76] 0 0
Up to 27 months
Secondary outcome [77] 0 0
Cmin of belrestotug in combination with dostarlimab followed by GSK4381562
Timepoint [77] 0 0
Up to 27 months
Secondary outcome [78] 0 0
Cmin of belrestotug in combination with dostarlimab
Timepoint [78] 0 0
Up to 27 months
Secondary outcome [79] 0 0
Cmin of belrestotug in combination with dostarlimab and GSK4381562
Timepoint [79] 0 0
Up to 27 months
Secondary outcome [80] 0 0
Cmin of belrestotug in combination with dostarlimab and nelistotug
Timepoint [80] 0 0
Up to 27 months
Secondary outcome [81] 0 0
China cohort: Cmin of belrestotug in combination with dostarlimab
Timepoint [81] 0 0
Up to 27 months
Secondary outcome [82] 0 0
AUC (0-t) of belrestotug in combination with dostarlimab followed by GSK4381562
Timepoint [82] 0 0
Up to 27 months
Secondary outcome [83] 0 0
AUC (0-t) of belrestotug in combination with dostarlimab
Timepoint [83] 0 0
Up to 27 months
Secondary outcome [84] 0 0
AUC (0-t) of belrestotug in combination with dostarlimab and GSK4381562
Timepoint [84] 0 0
Up to 27 months
Secondary outcome [85] 0 0
AUC (0-t) of belrestotug in combination with dostarlimab and nelistotug
Timepoint [85] 0 0
Up to 27 months
Secondary outcome [86] 0 0
China cohort: AUC (0-t) of belrestotug in combination with dostarlimab
Timepoint [86] 0 0
Up to 27 months
Secondary outcome [87] 0 0
AUC (0-infinity) of belrestotug in combination with dostarlimab followed by GSK4381562
Timepoint [87] 0 0
Up to 27 months
Secondary outcome [88] 0 0
AUC (0- infinity) of belrestotug in combination with dostarlimab
Timepoint [88] 0 0
Up to 27 months
Secondary outcome [89] 0 0
AUC (0- infinity) of belrestotug in combination with dostarlimab and GSK4381562
Timepoint [89] 0 0
Up to 27 months
Secondary outcome [90] 0 0
AUC (0- infinity) of belrestotug in combination with dostarlimab and nelistotug
Timepoint [90] 0 0
Up to 27 months
Secondary outcome [91] 0 0
China cohort: AUC (0- infinity) of belrestotug in combination with dostarlimab
Timepoint [91] 0 0
Up to 27 months
Secondary outcome [92] 0 0
China cohort: t1/2 of belrestotug in combination with dostarlimab
Timepoint [92] 0 0
Up to 27 months
Secondary outcome [93] 0 0
Cmax of nelistotug in combination with dostarlimab and belrestotug
Timepoint [93] 0 0
Up to 27 months
Secondary outcome [94] 0 0
Cmin of nelistotug in combination with dostarlimab and belrestotug
Timepoint [94] 0 0
Up to 27 months
Secondary outcome [95] 0 0
AUC (0-t) of nelistotug in combination with dostarlimab and belrestotug
Timepoint [95] 0 0
Up to 27 months
Secondary outcome [96] 0 0
AUC (0-infinity) of nelistotug in combination with dostarlimab and belrestotug
Timepoint [96] 0 0
Up to 27 months
Secondary outcome [97] 0 0
Cmax of GSK5764227 in combination with dostarlimab
Timepoint [97] 0 0
Up to 27 months
Secondary outcome [98] 0 0
Cmin of GSK5764227 in combination with dostarlimab
Timepoint [98] 0 0
Up to 27 months
Secondary outcome [99] 0 0
AUC (0-t) of GSK5764227 conjugated antibody (Ab) in combination with dostarlimab
Timepoint [99] 0 0
Up to 27 months
Secondary outcome [100] 0 0
AUC (0-t) of GSK5764227 small molecule toxin in combination with dostarlimab
Timepoint [100] 0 0
Up to 27 months
Secondary outcome [101] 0 0
AUC (0-infinity) of GSK5764227 conjugated Ab in combination with dostarlimab
Timepoint [101] 0 0
Up to 27 months
Secondary outcome [102] 0 0
AUC (0-infinity) of GSK5764227 small molecule toxin in combination with dostarlimab
Timepoint [102] 0 0
Up to 27 months

Eligibility
Key inclusion criteria
Inclusion criteria:

* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:

* Is not a woman of childbearing potential (WOCBP) or
* Is a WOCBP and using a contraceptive method that is highly effective with a failure rate of less than (<)1 percent ([%] per year), during the intervention period and for specified time after end of study treatment.
* A WOCBP must have a negative highly sensitive pregnancy test within 24-48 hours before the first dose of study intervention.
* Requirement for Arm I only: Male participants agree to use contraception and for their female partner to use contraception, if applicable.
* Histological or cytological documentation of loco-regionally recurrent solid tumors where curative treatment options have been exhausted, or metastatic solid tumors; types as follows:

* head and neck squamous cell carcinoma (HNSCC)
* non-small-cell lung cancer (NSCLC)
* breast cancer (BC)
* clear cell renal cell cancer (ccRCC)
* gastric cancer (GC)
* colorectal cancer (CRC)
* endometrial cancer (EC)
* epithelial ovarian, fallopian tube, and primary peritoneal cancers- Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists.
* Measurable disease per RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
* Life expectancy of at least 12 weeks.
* Adequate organ function, as defined in the protocol.
* For participants enrolled in a PK/PD cohort, participant agrees to a fresh tumor biopsy during Screening and at approximately 6-weeks after treatment initiation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with the following therapies (specified time periods are from last dose of prior treatment to first dose of study intervention):

* Any therapy directed against Polio virus receptor (PVR)-related immunoglobulin domain-containing (PVRIG) (COM701 or other anti-PVRIG monoclonal antibody [mAb]) or other cluster of differentiation (CD)226 axis receptor (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain [TIGIT] or CD96) at any time.
* For Arm I only, prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
* Other prior immunotherapy, chemotherapy, targeted therapy, biological therapy or radiation therapy within specified periods as defined in the protocol.
* Investigational therapy: if the participant has participated in a clinical study and has received an investigational product within 4 weeks or 5 half-lives of the investigational product (whichever is shorter).
* Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
* Toxicity from previous anticancer treatment, including:

* Greater than or equal to Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or
* History of myocarditis of any grade during a previous treatment with immunotherapy
* Toxicity related to prior treatment that has not resolved to less than or equal to (<=) Grade 1. Non clinically relevant Grade 2 toxicities, not constituting a safety risk by investigator judgment are allowed.
* Participant has a known additional malignancy that progressed or required active treatment within the last 2 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
China
State/province [8] 0 0
Jinan
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
France
State/province [10] 0 0
Dijon Cedex
Country [11] 0 0
France
State/province [11] 0 0
Lille
Country [12] 0 0
Japan
State/province [12] 0 0
Chiba
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Spain
State/province [15] 0 0
Barcelona
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
MAlaga
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Manchester
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
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?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com


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.