Back to resultsA Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Primary Purpose
Melanoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
V940
Pembrolizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
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 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) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: Has ocular or mucosal melanoma Has past or current cancer that has spread to other parts of the body 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
Sites / Locations
- Westmead Hospital-Department of Medical Oncology ( Site 1001)Recruiting
- Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)Recruiting
- Princess Alexandra Hospital ( Site 1003)Recruiting
- Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)Recruiting
- The Alfred Hospital-Medical Oncology Alfred Cancer Trials ( Site 1004)Recruiting
- One Clinical Research ( Site 1002)Recruiting
- Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et HématoloRecruiting
- Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)Recruiting
- FALP-UIDO ( Site 2400)Recruiting
- Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)Recruiting
- Bradfordhill-Clinical Area ( Site 2401)Recruiting
- HOSPITAL CLINICO DE VALENCIA ( Site 1604)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
V940 + Pembrolizumab
Placebo + Pembrolizumab
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Recurrence-Free Survival (RFS)
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.
Secondary Outcome Measures
Distant Metastasis-Free Survival (DMFS)
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.
Overall-Survival (OS)
OS is the length of time that people are alive after joining the study.
Number of Participants Who Experience an Adverse Event (AE)
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
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
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.
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
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.
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
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.
Full Information
NCT ID
NCT05933577
First Posted
June 27, 2023
Last Updated
October 13, 2023
Sponsor
Merck Sharp & Dohme LLC
Collaborators
ModernaTX, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05933577
Brief Title
A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2023 (Actual)
Primary Completion Date
October 26, 2029 (Anticipated)
Study Completion Date
September 26, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
Collaborators
ModernaTX, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
1089 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
V940 + Pembrolizumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo + Pembrolizumab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
V940
Other Intervention Name(s)
mRNA-4157, Individualized neoantigen therapy
Intervention Description
IM injection
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, Keytruda®
Intervention Description
IV infusion
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline, Dextrose
Intervention Description
IM injection
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS)
Description
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.
Time Frame
Up to approximately 74 months
Secondary Outcome Measure Information:
Title
Distant Metastasis-Free Survival (DMFS)
Description
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.
Time Frame
Up to approximately 85 months
Title
Overall-Survival (OS)
Description
OS is the length of time that people are alive after joining the study.
Time Frame
Up to approximately 85 months
Title
Number of Participants Who Experience an Adverse Event (AE)
Description
An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported.
Time Frame
Up to approximately 68 weeks
Title
Number of Participants Who Discontinue Study Treatment Due to an AE
Description
An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported.
Time Frame
Up to approximately 56 weeks
Title
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
Description
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.
Time Frame
Baseline and up to approximately 85 months
Title
Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
Description
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.
Time Frame
Baseline and up to approximately 85 months
Title
Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30
Description
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.
Time Frame
Baseline and up to approximately 85 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has ocular or mucosal melanoma
Has past or current cancer that has spread to other parts of the body
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Westmead Hospital-Department of Medical Oncology ( Site 1001)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61298455200
Facility Name
Melanoma Institute Australia-Clinical Trials Unit ( Site 1000)
City
Wollstonecraft
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61299117336
Facility Name
Princess Alexandra Hospital ( Site 1003)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0448632604
Facility Name
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 1005)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+6138559500
Facility Name
The Alfred Hospital-Medical Oncology Alfred Cancer Trials ( Site 1004)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61390763129
Facility Name
One Clinical Research ( Site 1002)
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0410565868
Facility Name
Centre Hospitalier de l'Université de Montréal-Unité de Recherche Clinique en Oncologie et Hématolo
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5148908444
Facility Name
Centre intégré de cancérologie du CHU de Québec Université L-Hemato-Oncology ( Site 1101)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4186915200
Facility Name
FALP-UIDO ( Site 2400)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56224457254
Facility Name
Clínica UC San Carlos de Apoquindo-Hemato-Oncology ( Site 2402)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7620002
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56223546919
Facility Name
Bradfordhill-Clinical Area ( Site 2401)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56998744662
Facility Name
HOSPITAL CLINICO DE VALENCIA ( Site 1604)
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
34961973500441687
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
http://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=V940-001&&kw=V940-001
Description
Plain Language Summary
Learn more about this trial
A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
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