An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
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)
1 other identifier
interventional
267
2 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2019
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2019
CompletedStudy Start
First participant enrolled
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2032
December 3, 2025
November 1, 2025
13.4 years
March 29, 2019
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging
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 7 years
Secondary Outcomes (3)
Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging
Up to 7 years
Number of Participants With Adverse Events (AEs)
Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm)
Number of Participants Who Discontinued Due to AEs
Baseline through 100 days after last mRNA-4157 dose or up to 90 days after the last dose of pembrolizumab, whichever is later (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm)
Study Arms (2)
mRNA-4157 and Pembrolizumab
EXPERIMENTALParticipants 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.
Pembrolizumab
ACTIVE COMPARATORParticipants 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (23)
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 D.C., District of Columbia, 20007, United States
Orlando Health UF Health Cancer Center
Orlando, Florida, 32806, United States
Northside Hospital
Atlanta, Georgia, 30342, 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
St 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
Melanoma Institute Australia
North Sydney, New South Wales, 2060, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Affinity Clinical Research
Murdoch, Western Australia, 6150, Australia
One Clinical Research Perth
Murdoch, Western Australia, 6150, Australia
St John of God Hospital Subiaco
Subiaco, Western Australia, 6008, Australia
Related Publications (1)
Weber JS, Carlino MS, Khattak A, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Shaheen M, Segar J, Medina T, Atkinson V, Gibney GT, Luke JJ, Thomas S, Buchbinder EI, Healy JA, Huang M, Morrissey M, Feldman I, Sehgal V, Robert-Tissot C, Hou P, Zhu L, Brown M, Aanur P, Meehan RS, Zaks T. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024 Feb 17;403(10427):632-644. doi: 10.1016/S0140-6736(23)02268-7. Epub 2024 Jan 18.
PMID: 38246194DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2019
First Posted
April 1, 2019
Study Start
July 18, 2019
Primary Completion (Estimated)
November 30, 2032
Study Completion (Estimated)
November 30, 2032
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share