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NCT03897881 · ClinicalTrials.gov registry record · Phase 2
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 study of Melanoma, sponsored by ModernaTX.
- Active
- Registry status
- Phase 2
- Development phase
- 267
- Enrollment target
- 20
- Study locations
NCT03897881: Active Phase 2 study of Melanoma, sponsored by ModernaTX.
NCT03897881 is a Phase 2 study of Melanoma that is active but no longer recruiting, run by ModernaTX. The registered enrollment target is 267 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03897881, a Phase 2 study of Melanoma, is active but no longer recruiting, sponsored by ModernaTX.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 267 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG mRNA-4157
Study Locations (20)
California
- California Pacific Medical Center Research Institute -CPMCRI - San Francisco
- Angeles Clinic and Research Institute - Santa Monica
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New South Wales
- Melanoma Institute Australia - North Sydney
- Westmead Hospital - Westmead
Arizona
- University of Arizona - Tucson
Colorado
- University of Colorado Cancer Center - Aurora
Connecticut
- Smilow Cancer Center at Yale New Haven Hospital - New Haven
District of Columbia
- Lombardi Cancer Center - Washington D.C.
Florida
- Orlando Health UF Health Cancer Center - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2032-11-30 |
| Phase | Phase 2 |
What the registry record for NCT03897881 still lists
NCT03897881 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03897881 names 20 study sites across 17 states, led by California, Massachusetts, New South Wales.
Frequently Asked Questions
What is clinical trial NCT03897881 about?
NCT03897881 is a clinical study titled "An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With 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.
What is the current status of trial NCT03897881?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 267 participants. The study started on 2019-07-18. Estimated completion is 2032-11-30.
What conditions does trial NCT03897881 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT03897881?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), mRNA-4157 (DRUG).
Who is sponsoring clinical trial NCT03897881?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03897881 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03897881's enrollment target sits among peer trials
267 56th of 266 higher than 210 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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