In short
This article explores the clinical trial of mRNA-4157, a personalized cancer vaccine, in combination with pembrolizumab for patients with high-risk melanoma. The study aims to assess whether this combination therapy improves recurrence-free survival compared to pembrolizumab alone after complete resection of cutaneous melanoma.
At a glance
- Study Title
- Adjuvant Immunotherapy with mRNA-4157 and Pembrolizumab vs. Pembrolizumab Alone After Complete Resection of High-Risk Melanoma
- Primary Objective
- Assess if mRNA-4157 + pembrolizumab improves recurrence-free survival compared to pembrolizumab alone
- Study Arms
- 1. mRNA-4157 + Pembrolizumab; 2. Pembrolizumab alone
- Treatment Duration
- Up to 18 cycles (approximately 1 year)
- Primary Outcome
- Recurrence-Free Survival (RFS)
- Secondary Outcomes
- 1. Distant Metastasis-Free Survival (DMFS); 2. Number of participants with Adverse Events; 3. Number of participants who discontinued due to Adverse Events
- Follow-up Period
- Up to 5 years
What is MRNA-4157?
MRNA-4157 is a new type of cancer treatment called a personalized cancer vaccine. It is specifically designed to treat melanoma, a serious type of skin cancer. This vaccine is currently being studied in clinical trials to see how well it works in patients who have had their melanoma surgically removed but are at high risk of the cancer coming back.
How Does MRNA-4157 Work?
MRNA-4157 is described as an Individualized Neoantigen Therapy. This means that the vaccine is custom-made for each patient based on the specific genetic mutations found in their cancer cells. The vaccine teaches the patient's immune system to recognize and attack these cancer-specific markers, potentially preventing the cancer from returning.
Clinical Trial Overview
A clinical trial called KEYNOTE-942 is currently studying MRNA-4157. This trial aims to determine if using MRNA-4157 along with another cancer drug called pembrolizumab is more effective than using pembrolizumab alone in preventing melanoma from coming back after surgery.
Treatment Arms
The study has two treatment groups:
- MRNA-4157 and Pembrolizumab: Patients in this group receive up to 9 doses of MRNA-4157 every 21 days. They also receive pembrolizumab every 21 days for up to 18 cycles (about 1 year of treatment).
- Pembrolizumab alone: Patients in this group only receive pembrolizumab every 21 days for up to 18 cycles.
In both groups, treatment continues until the cancer returns, side effects become too severe, or the treatment period ends, whichever happens first.
Primary Outcome
The main goal of the study is to measure Recurrence-Free Survival (RFS). This means they're tracking how long patients live without their cancer coming back after starting treatment. They use medical imaging tests to check for any signs of the cancer returning.
Secondary Outcomes
The study is also looking at other important factors:
- Distant Metastasis-Free Survival (DMFS): This measures how long patients live without the cancer spreading to distant parts of their body.
- Safety: The researchers are carefully monitoring any side effects or adverse events that patients experience during the treatment.
Safety Considerations
As with any new treatment, safety is a top priority. The study is closely tracking:
- The number of patients who experience side effects (adverse events)
- How many patients have to stop treatment due to side effects
Patients are monitored for side effects during treatment and for a period after treatment ends. For those receiving MRNA-4157 and pembrolizumab, this monitoring continues for 100 days after the last MRNA-4157 dose. For those receiving only pembrolizumab, monitoring continues for 90 days after the last dose. In total, all patients are followed for up to 5 years.