RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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 (KEYNOTE- 942)

Quick Facts

Study Start:2019-07-18
Study Completion:2029-09-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03897881

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
  2. * Complete resection within 13 weeks prior to the first dose of pembrolizumab
  3. * Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
  4. * Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
  5. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  6. * Normal organ and marrow function reported at screening
  1. * Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry
  2. * Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted)
  3. * Live vaccine within 30 days prior to the first dose of pembrolizumab
  4. * Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample
  5. * Active autoimmune disease
  6. * Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
  7. * Solid organ or allogeneic bone marrow transplant
  8. * Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
  9. * Prior interstitial lung disease
  10. * Clinically significant heart failure
  11. * Known history of human immunodeficiency virus (HIV)
  12. * Known active hepatitis B or C
  13. * Active infection requiring treatment

Contacts and Locations

Study Contact

Moderna Clinical Trials Support Center
CONTACT
1-877-777-7187
clinicaltrials@modernatx.com

Study Locations (Sites)

University of Arizona
Tucson, Arizona, 85719
United States
California Pacific Medical Center Research Institute -CPMCRI
San Francisco, California, 94115
United States
Angeles Clinic and Research Institute
Santa Monica, California, 90404
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut, 06520
United States
Lombardi Cancer Center
Washington, District of Columbia, 20007
United States
Orlando Health UF Health Cancer Center
Orlando, Florida, 32806
United States
UPMC Hillman Cancer Center
Chicago, Illinois, 60637
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
NYU Langone Medical Center
New York, New York, 10016
United States
Providence Cancer Institute
Portland, Oregon, 97213
United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
United States
Texas Oncology PA
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

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 Registration Dates

Study Start Date2019-07-18
Study Completion Date2029-09-09

Study Record Updates

Study Start Date2019-07-18
Study Completion Date2029-09-09

Terms related to this study

Keywords Provided by Researchers

  • mRNA-4157
  • Individualized Neoantigen Therapy
  • INT
  • Pembrolizumab
  • Moderna

Additional Relevant MeSH Terms

  • Melanoma