Trial purpose
Cancer treatment
Tumor type
Skin
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two treatment arms.
In Arm A (Experimental), participants will receive V940 + pembrolizumab. Participants will receive up to 9 doses of V940 via an injection into the muscle (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks).
In Arm B (Active Comparator), participants will receive placebo + pembrolizumab. Participants will receive up to 9 doses of a placebo via an injection into the muscle (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks).
In both groups, treatment will be given until cancer recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner.
Conditions
This trial is treating people with high-risk stage II-IV melanoma that has been surgically removed
Eligibility
Inclusion
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
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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Merck Sharp & Dohme LLC
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
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