Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03897881 | An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) | PHASE2 | ACTIVE NOT_RECRUITING | 267 | — | — | Jul 18, 2019 | Nov 30, 2032 | Dec 3, 2025 | 23 | United States, Australia |
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.
| Arm | Type | Description |
|---|---|---|
| mRNA-4157 and Pembrolizumab | EXPERIMENTAL | 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. |
| Pembrolizumab | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| mRNA-4157 | DRUG | Individualized Neoantigen Therapy |
| Pembrolizumab | BIOLOGICAL | Intravenous infusion |
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 cl...