This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

Phase 2

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

Sponsor:

Moderna

Code:

NCT03897881

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mRNA-4157

Pembrolizumab

Study Details

Brief summary:

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.

Conditions

Melanoma

Study ID

NCT03897881

Start date

Jul 18, 2019

Status verified date

Jun, 2025

Completion date

Sep 9, 2029

Anticipated

Primary completion date

Sep 9, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

267 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

mRNA-4157

Individualized Neoantigen Therapy

Pembrolizumab

Intravenous infusion

Primary outcome measure

Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging [ Time Frame: Up to 7 years ]

Central Contacts and Locations

Central contacts

Moderna WeCare Team

1-866-663-3762 WeCareClinicalTrials@modernatx.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Montaser Shaheen

812-230-1521 shaheenm@email.arizona.edu

California Pacific Medical Center Research Institute -CPMCRI

Recruiting

San Francisco, California, United States, 94115

Contacts

Kevin Kim, MD

415-885-8600 kimkb@sutterhealth.org

Angeles Clinic and Research Institute

Recruiting

Santa Monica, California, United States, 90404

Contacts

Mark Faries, MD

310-582-7020 mfaries@theangelesclinic.org

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Karl Lewis, MD

720-848-0637 karl.lewis@ucdenver.edu

Smilow Cancer Center at Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Sarah Weiss, MD

203-785-6378 sarah.weiss.sw842@yale.edu

Lombardi Cancer Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Geoffrey Gibney, MD

813-745-3437 geoffrey.t.gibney@gunet.georgetown.edu

Orlando Health UF Health Cancer Center

Recruiting

Orlando, Florida, United States, 32806

Contacts

Sajeve Thomas

954-663-7551 Sajeve.thomas@orlandohealth.com

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Harpaul Gill

229-834-2522 hgill@atlantacancercare.com

UPMC Hillman Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jason Luke

773-702-0963 lukejj@upmc.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ryan Sullivan, MD

617-632-5470 rsullivan7@mgh.harvard.edu

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Elizabeth Buchbinder

617-632-9271 elizabeth_buchbinder@dfci.harvard.edu

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Leonel Hernandez Aya, MD

314-747-7510 lhernand@dom.wustl.edu

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777 OncologyResearchReferral@hmhn.org

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Janice Mehnert

212-731-5431 janice.mehnert@nyulangone.org

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

Contacts

Mathew Taylor

503-494-8534 matthew.taylor@providence.org

Sarah Cannon Cancer Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Meredith McKean, MD

615-329-7274 mmckean@tnonc.com

Texas Oncology PA

Recruiting

Dallas, Texas, United States, 75246

Contacts

Charles Cowey, MD

214-370-1000 lance.cowey@usoncology.com

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Jun 8, 2025

Last verified

Jun, 2025

Keywords

mRNA-4157
Individualized Neoantigen Therapy
INT
Pembrolizumab
Moderna

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2025-06-08.