A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

• ClinicalTrials.gov Identifier: NCT05933577
• Recruitment Status: Recruiting
• First Posted: July 6, 2023
• Last Update Posted: April 24, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Collaborator: ModernaTX, Inc.
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: June 27, 2023
• First Posted Date: July 6, 2023
• Last Update Posted Date: April 24, 2024
• Actual Study Start Date: July 19, 2023
• Estimated Primary Completion Date: October 26, 2029 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 27, 2023)

Recurrence-Free Survival (RFS) [ Time Frame: Up to approximately 74 months ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 27, 2023)

• Distant Metastasis-Free Survival (DMFS) [ Time Frame: Up to approximately 85 months ]
  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) [ Time Frame: Up to approximately 85 months ]
  OS is the length of time that people are alive after joining the study.
• Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 68 weeks ]
  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 [ Time Frame: Up to approximately 56 weeks ]
  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 [ Time Frame: Baseline and up to approximately 85 months ]
  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 [ Time Frame: Baseline and up to approximately 85 months ]
  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 [ Time Frame: Baseline and up to approximately 85 months ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 (INTerpath-001)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Double blind

Primary Purpose: Treatment

• Condition: Melanoma

Intervention

• Biological: V940
  IM injection
  Other Names:

  • mRNA-4157
  • Individualized neoantigen therapy
• Biological: Pembrolizumab
  IV infusion
  Other Names:

  • MK-3475
  • Keytruda®
• Other: Placebo
  IM injection
  Other Names:

  • Normal saline
  • Dextrose

Study Arms

• 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.
  Interventions:

  • Biological: V940
  • Biological: Pembrolizumab
• 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.
  Interventions:

  • Biological: Pembrolizumab
  • Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 27, 2023): 1089
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 26, 2030
• Estimated Primary Completion Date: October 26, 2029 (Final data collection date for primary outcome measure)

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 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)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Toll Free Number; 1-888-577-8839; Trialsites@merck.com

• Listed Location Countries: Argentina, Australia, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Greece, Israel, Italy, New Zealand, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States

Administrative Information

• NCT Number: NCT05933577
• Other Study ID Numbers: V940-001; V940-001 ( Other Identifier: Merck ); 2023-503652-27-00 ( Other Identifier: EU CT number ); jRCT2041230169 ( Registry Identifier: jRCT )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: ModernaTX, Inc.

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: April 2024