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Clinical Trials List

Protocol NumberV940-001

NCT Number(ClinicalTrials.gov Identfier)NCT05933577

Active

2023-09-01 - 2031-12-31

Phase III

Not yet recruiting3

Recruiting1

ICD-10C43.9

Malignant melanoma of skin, unspecified

ICD-10D03.9

Melanoma in situ, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9172.9

Malignant melanoma of skin, site unspecified

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)

Trial Applicant

Merck Sharp & Dohme (I.A.) LLC
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Yu-Li Su 無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Wen-Cheng Chang 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Chi Lin 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chia-Jui Yen Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Melanoma

Objectives

main purpose ‧ Compare the RFS of V940 plus pembrolizumab versus placebo plus pembrolizumab. Hypothesis (H1): V940 plus pembrolizumab is superior to placebo plus pembrolizumab in RFS, as assessed by trial moderators. secondary purpose ‧ DMFS hypothesis comparing V940 plus pembrolizumab versus placebo plus pembrolizumab (H2): V940 plus pembrolizumab is superior to placebo plus pembrolizumab on DMFS as assessed by the trial moderator. ‧ Compare the OS of V940 plus pembrolizumab to placebo plus pembrolizumab. Hypothesis (H3): V940 plus pembrolizumab is better than placebo plus pembrolizumab in terms of OS. ‧ To assess the safety and tolerability of V940 plus pembrolizumab. ‧ To assess the mean change from baseline in V940 plus pembrolizumab compared to placebo plus pembrolizumab in overall health/QoL, physical function, and role functioning as measured by the EORTC QLQ-C30.

Test Drug

V940 (mRNA-4157); KEYTRUDAR

Active Ingredient

V940 (mRNA-4157)
Pembrolizumab

Dosage Form

Injection
Injection

Dosage

1 mg/mL
25 mg/mL

Endpoints

‧ RFS: The time from random assignment to any recurrence (local, locoregional, regional, or distal) as assessed by the trial moderator, or death from any cause, whichever occurs first.
‧ OS: time from random assignment to death from any cause.
‧ AE, discontinuation of trial treatment due to AE
‧ Evaluate the change in scores since the base period for the following items:
- Overall health status/QoL score (QLQ-C30 items 29 and 30)
- Physical function score (QLQ-C30 items 1 to 5)
- Role function score (QLQ-C30 items 6 and 7)

Inclution 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

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

The Estimated Number of Participants

Taiwan

12 participants
Global

1089 participants