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RecruitingLast updated: 28 March 2024

V940-001: Researchers in this study want to know if combining two immunotherapies (called V940 and pembrolizumab) is better than receiving pembrolizumab alone at preventing high-risk melanoma from returningA 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

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 patients with high-risk stage II-IV melanoma that has been surgically removed

Cancer

Skin Cancers Skin

Age

People18+

Phase

III

Trial Acronym

V940-001

More information

Trial Identifiers

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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

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

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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