IRB #

STUDY00019746

Title

A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma

Principal Investigator

Matthew Taylor

Study Purpose

The purpose of the study is to test whether the combination of pembrolizumab and mRNA-4157 works better than just pembrolizumab to prevent your type of cancer from coming back. This study will also look at safety and tolerability, and whether mRNA-4157 and pembrolizumab have any effect on your immune system.

Medical Condition(s)

Stage III or IV melanoma which has been surgically removed.

Eligibility Criteria

1. Men and women 18 years or older
2. Stage III or IV Melanoma
3. Adequate organ function
4. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will receive study drug for about 1 year and visit the study site as instructed by the investigator and staff. After you stop the study drug, you will continue to be followed on the study for up to 3 years to see if your cancer has come back or spread.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

ModernaTX, Inc.

Recruitment End

09/30/2020

Compensation Provided

No


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