An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

December 12, 2023 updated by: ModernaTX, Inc.

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 (KEYNOTE- 942)

The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

257

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • North Sydney, New South Wales, Australia, 2060
        • Active, not recruiting
        • Melanoma Institute Australia
      • Westmead, New South Wales, Australia, 2145
        • Active, not recruiting
        • Westmead Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Active, not recruiting
        • Princess Alexandra Hospital
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Active, not recruiting
        • Affinity Clinical Research
      • Subiaco, Western Australia, Australia, 6008
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
    • California
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center Research Institute -CPMCRI
        • Contact:
      • Santa Monica, California, United States, 90404
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Cancer Center
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Smilow Cancer Center at Yale New Haven Hospital
        • Contact:
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Orlando, Florida, United States, 32806
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02115
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97213
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Cancer Center
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
  • Complete resection within 13 weeks prior to the first dose of pembrolizumab
  • Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
  • Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Normal organ and marrow function reported at screening

Key Exclusion Criteria:

  • Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry
  • Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted)
  • Live vaccine within 30 days prior to the first dose of pembrolizumab
  • Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample
  • Active autoimmune disease
  • Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
  • Solid organ or allogeneic bone marrow transplant
  • Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
  • Prior interstitial lung disease
  • Clinically significant heart failure
  • Known history of human immunodeficiency virus (HIV)
  • Known active hepatitis B or C
  • Active infection requiring treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mRNA-4157 and Pembrolizumab
Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Biological: Pembrolizumab
Intravenous infusion
Drug: mRNA-4157
Individualized Neoantigen Therapy
Active Comparator: Pembrolizumab
Participants will receive pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Biological: Pembrolizumab
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging
Time Frame: Up to 5 years
RFS is defined as the time between the date of first dose of pembrolizumab and the date of recurrence (local, regional, or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging
Time Frame: Up to 5 years
DMFS is defined as the time between the date of first dose of pembrolizumab and the date of the first distant metastasis or the date of death (whatever the cause), whichever occurs first.
Up to 5 years
Number of Participants With Adverse Events (AEs)
Time Frame: Baseline through 100 days after last mRNA-4157 dose (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) (up to a total of 5 years for both arms)
Baseline through 100 days after last mRNA-4157 dose (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) (up to a total of 5 years for both arms)
Number of Participants Who Discontinued Due to AEs
Time Frame: Baseline through 100 days after last mRNA-4157 dose (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) (up to a total of 5 years for both arms)
Baseline through 100 days after last mRNA-4157 dose (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) (up to a total of 5 years for both arms)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2019

Primary Completion (Estimated)

September 9, 2029

Study Completion (Estimated)

September 9, 2029

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-4157-P201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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