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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06305767
Registration number
NCT06305767
Ethics application status
Date submitted
5/03/2024
Date registered
12/03/2024
Titles & IDs
Public title
A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)
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Scientific title
A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection
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Secondary ID [1]
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V940-005
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Secondary ID [2]
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V940-005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer
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Condition category
Condition code
Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Other - V940
Other interventions - Placebo
Experimental: Pembrolizumab + V940 - Participants receive 400 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of every 6-week cycle for up to 9 cycles, plus 1 mg of V940 via intramuscular (IM) injection once available every 3 weeks up to a total of 9 doses. V940 doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
Active comparator: Pembrolizumab + Placebo - Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle for up to 9 cycles. Placebo will be administered every 3 weeks up to a total of 9 doses. The total duration of treatment is up to approximately 13 months.
Treatment: Other: Pembrolizumab
Administered via IV infusion at a dose of 400 mg on Day 1 of every 6-week cycle (Q6W) for up to 9 cycles.
Treatment: Other: V940
Administered via IM injection at a dose of 1 mg every 3 weeks (Q3W) for up to 9 doses.
Other interventions: Placebo
V940 diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease Free Survival (DFS)
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Assessment method [1]
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DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (=pT2) disease in the urothelial tract (upper tract or lower tract) or high grade T1 disease in the upper tract on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for each arm.
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Timepoint [1]
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Up to approximately 28 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for each arm.
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Timepoint [1]
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Up to approximately 28 months
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Secondary outcome [2]
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Distant Metastasis-Free Survival (DMFS)
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Assessment method [2]
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DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for each arm.
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Timepoint [2]
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Up to approximately 28 months
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Secondary outcome [3]
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Number of Participants Who Experience an Adverse Event (AE)
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Assessment method [3]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience AEs will be reported for each arm.
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Timepoint [3]
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Up to approximately 16 months
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Secondary outcome [4]
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Number of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [4]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an adverse event will be presented. The number of participants who discontinue study treatment due to an AE will be reported for each arm.
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Timepoint [4]
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Up to approximately 13 months
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Eligibility
Key inclusion criteria
* Has muscle-invasive urothelial carcinoma (MIUC)
* Has dominant histology of UC
* Has high-risk pathologic disease after radical resection
* Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS)
* Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has received prior systemic anticancer therapy
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has known additional malignancy that is progressing or has required active treatment <3 years prior to study randomization
* Has severe hypersensitivity to either V940 or pembrolizumab and/or any of their excipients
* Has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* Has active hepatitis B and hepatitis C virus infection
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/04/2031
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Macquarie University-MQ Health Clinical Trials Unit ( Site 1803) - Macquarie University
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Recruitment hospital [2]
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Westmead Hospital-Department of Medical Oncology ( Site 1802) - Westmead
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Recruitment hospital [3]
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One Clinical Research ( Site 1807) - Nedlands
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Florida
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United States of America
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Ohio
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Pennsylvania
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Texas
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Canada
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Quebec
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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France
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Haute-Garonne
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France
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Ile-de-France
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France
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Maine-et-Loire
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France
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Paris
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Germany
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Bayern
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Italy
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Lazio
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Italy
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Italy
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Italy
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Italy
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Milano
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Auckland
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Barcelona
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Spain
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Madrid, Comunidad De
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Spain
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Madrid
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Spain
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Sevilla
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Sweden
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Stockholms Lan
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Sweden
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Turkey
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Ankara
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Turkey
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Izmir
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United Kingdom
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England
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United Kingdom
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London, City Of
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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ModernaTX, Inc.
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.
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Trial website
https://clinicaltrials.gov/study/NCT06305767
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Email
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Contact person for public queries
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Toll Free Number
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Address
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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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/NCT06305767