Trials / Active Not Recruiting
Active Not RecruitingNCT03897881
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)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 267 (actual)
- Sponsor
- ModernaTX, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mRNA-4157 | Individualized Neoantigen Therapy |
| BIOLOGICAL | Pembrolizumab | Intravenous infusion |
Timeline
- Start date
- 2019-07-18
- Primary completion
- 2032-11-30
- Completion
- 2032-11-30
- First posted
- 2019-04-01
- Last updated
- 2025-12-03
Locations
23 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03897881. Inclusion in this directory is not an endorsement.