WeTrials
AI-Simplified
NCT05933577

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)

What is this study?

This study is testing an experimental, personalized cancer vaccine combined with an immunotherapy drug to see if it can better prevent high-risk melanoma from coming back after surgery. The goal is to see if this combination works better at training your immune system to fight off cancer than using the immunotherapy drug alone.

Who can participate?

This trial is for people who have recently had surgery to remove Stage IIB, IIC, III, or IV melanoma and have no visible cancer left. You must have had your surgery within the last 13 weeks and cannot have received other full-body cancer treatments yet.

What will happen?

Participants will receive either the personalized vaccine plus immunotherapy or a placebo plus immunotherapy. You will be monitored closely by the research team to track your health, how your body reacts to the treatment, and to ensure your cancer remains away.

Where and when?

This study is currently active but is no longer recruiting new participants. It is taking place at various medical centers in Springdale, Arkansas, and Los Angeles and San Francisco, California.

Key Points
  • 1The vaccine is personalized, meaning it is created specifically using your own cancer cells to help your body recognize and fight the disease.
  • 2Participation requires being able to start treatment within 13 weeks of your final surgery.
  • 3The study compares a new combined treatment against the current standard of care to find more effective ways to prevent cancer recurrence.
Conditions Studied
This study is investigating treatments for the following conditions
Melanoma

This summary was generated using AI and may not capture all details. Always consult with a healthcare professional for medical advice.