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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
Date last updated
18/11/2024

Titles & IDs
Public title
A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
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)
Secondary ID [1] 0 0
V940-001
Secondary ID [2] 0 0
V940-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence-Free Survival (RFS)
Timepoint [1] 0 0
Up to approximately 74 months
Secondary outcome [1] 0 0
Distant Metastasis-Free Survival (DMFS)
Timepoint [1] 0 0
Up to approximately 85 months
Secondary outcome [2] 0 0
Overall-Survival (OS)
Timepoint [2] 0 0
Up to approximately 85 months
Secondary outcome [3] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [3] 0 0
Up to approximately 68 weeks
Secondary outcome [4] 0 0
Number of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [4] 0 0
Up to approximately 56 weeks
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline and up to approximately 85 months
Secondary outcome [6] 0 0
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Timepoint [6] 0 0
Baseline and up to approximately 85 months
Secondary outcome [7] 0 0
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Timepoint [7] 0 0
Baseline and up to approximately 85 months

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/09/2030
Actual
Sample size
Target
1089
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital-Department of Medical Oncology ( Site 1001) - Westmead
Recruitment hospital [2] 0 0
Melanoma Institute Australia-Clinical Trials Unit ( Site 1000) - Wollstonecraft
Recruitment hospital [3] 0 0
Princess Alexandra Hospital ( Site 1003) - Brisbane
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005) - Melbourne
Recruitment hospital [5] 0 0
Paula Fox Melanoma & Cancer Centre ( Site 1004) - Melbourne
Recruitment hospital [6] 0 0
One Clinical Research ( Site 1002) - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
2065 - Wollstonecraft
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
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Arkansas
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Attiki
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Kentriki Makedonia
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Madrid, Comunidad De
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Madrid
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Spain
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Malaga
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Valenciana, Comunitat
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Barcelona
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Skane Lan
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Grisons
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Zurich
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Kaohsiung
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Taoyuan
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Turkey
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Istanbul
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Izmir
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United Kingdom
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Bristol, City Of
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Cambridgeshire
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England
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United Kingdom
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Kensington And Chelsea
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London, City Of
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Midlothian
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Oxfordshire
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Leeds
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
ModernaTX, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05933577
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05933577