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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05933577
Registration number
NCT05933577
Ethics application status
Date submitted
27/06/2023
Date registered
6/07/2023
Titles & IDs
Public title
A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
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Scientific title
A Phase 3, 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 Stage II-IV Melanoma (INTerpath-001)
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Secondary ID [1]
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V940-001
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Secondary ID [2]
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V940-001
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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:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - V940
Treatment: Other - Pembrolizumab
Other interventions - Placebo
Experimental: V940 + Pembrolizumab - Participants receive up to 9 doses of V940 via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Active comparator: Placebo + Pembrolizumab - Participants receive up to 9 doses of dose matched placebo to V940 via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Treatment: Other: V940
IM injection
Treatment: Other: Pembrolizumab
IV infusion
Other interventions: Placebo
IM injection
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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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Recurrence-Free Survival (RFS)
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Assessment method [1]
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RFS is defined as the length of time from when the participant starts the study until either the cancer comes back, or the cancer spreads as assessed by the investigator, or death due to any cause.
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Timepoint [1]
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Up to approximately 74 months
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Secondary outcome [1]
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Distant Metastasis-Free Survival (DMFS)
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Assessment method [1]
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DMFS is the length of time from when the participant starts the study until either the cancer spreads from where it started to other parts of the body as assessed by the investigator, or death due to any cause.
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Timepoint [1]
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Up to approximately 85 months
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Secondary outcome [2]
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Overall-Survival (OS)
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Assessment method [2]
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OS is the length of time that people are alive after joining the study.
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Timepoint [2]
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Up to approximately 85 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 a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
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Timepoint [3]
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Up to approximately 68 weeks
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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 a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
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Timepoint [4]
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Up to approximately 56 weeks
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Secondary outcome [5]
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Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score
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Assessment method [5]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
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Timepoint [5]
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Baseline and up to approximately 85 months
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Secondary outcome [6]
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Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
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Assessment method [6]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better level of physical functioning. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
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Timepoint [6]
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Baseline and up to approximately 85 months
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Secondary outcome [7]
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Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
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Assessment method [7]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6-7) combined score will be presented.
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Timepoint [7]
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Baseline and up to approximately 85 months
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Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:
* Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma
* Has not received any prior systemic therapy for their melanoma beyond surgical resection
* No more than 13 weeks have passed between final surgical resection that rendered the participant disease-free and the first dose of pembrolizumab
* Is disease free at the time of providing documented consent for the study
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
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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
The main exclusion criteria include but are not limited to the following:
* Has ocular or mucosal melanoma
* Has cancer that has spread to other parts of the body and cannot be removed with surgery
* Has heart failure within the past 6 months
* Has received prior cancer therapy or another cancer vaccine
* Has another known cancer that that has spread to other parts of the body or has required treatment within the past 3 years
* Has severe reaction to study medications or any of their substance used to prepare a drug
* Have not recovered from major surgery or have ongoing surgical complications
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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 assessing the outcomes
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 3
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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
19/07/2023
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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
26/09/2030
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Actual
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Sample size
Target
1089
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital-Department of Medical Oncology ( Site 1001) - Westmead
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Recruitment hospital [2]
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Melanoma Institute Australia-Clinical Trials Unit ( Site 1000) - Wollstonecraft
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Recruitment hospital [3]
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Princess Alexandra Hospital ( Site 1003) - Brisbane
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Recruitment hospital [4]
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Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005) - Melbourne
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Recruitment hospital [5]
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The Alfred Hospital-Medical Oncology Alfred Cancer Trials ( Site 1004) - Melbourne
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Recruitment hospital [6]
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One Clinical Research ( Site 1002) - Nedlands
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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2065 - Wollstonecraft
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Recruitment postcode(s) [3]
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4102 - Brisbane
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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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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Arkansas
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California
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Connecticut
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Florida
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Iowa
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Hovedstaden
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Attiki
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Kentriki Makedonia
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Greece
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Thessaloniki
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Afula
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Italy
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Italy
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Napoli
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Tokyo
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Korea, Republic of
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Seoul
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Cataluna
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Madrid, Comunidad De
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United Kingdom
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State/province [111]
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0
England
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Country [112]
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0
United Kingdom
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State/province [112]
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Kensington And Chelsea
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Country [113]
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0
United Kingdom
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State/province [113]
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London, City Of
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Country [114]
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0
United Kingdom
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State/province [114]
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0
Midlothian
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Country [115]
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0
United Kingdom
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State/province [115]
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0
Oxfordshire
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Country [116]
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0
United Kingdom
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State/province [116]
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0
Leeds
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Country [117]
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0
United Kingdom
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State/province [117]
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0
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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Country
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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0
ModernaTX, Inc.
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid \[mRNA\]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
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Trial website
https://clinicaltrials.gov/study/NCT05933577
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
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Toll Free Number
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0
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0
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Phone
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0
1-888-577-8839
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Fax
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0
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Email
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0
[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/NCT05933577