Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-4157 · 2 trials · 2 indications
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. |
| Part A: Dose Escalation and Dose Expansion | EXPERIMENTAL | Participants will receive mRNA-4157 via an intramuscular (IM) injection on Day 1 of each 21-day cycle for up to 9 cycles. |
| Part B: Dose Escalation and Dose Expansion | EXPERIMENTAL | Participants will receive mRNA-4157 via an IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner. |
| Part A2: Dose Expansion | EXPERIMENTAL | Participants will receive mRNA-4157 via an IM injection on Day 1 of each 21-day cycle and a SoC treatment every 2 weeks (Q2W) on Day 1 of each 21-day cycle starting from Cycle 5 of mRNA-4157 for up to 12 cycles. |
| Part C: Dose Expansion | EXPERIMENTAL | Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner. |
| Part D: Dose Expansion | EXPERIMENTAL | Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 18 cycles (approximately 1 year of treatment), whichever is sooner. |
| Part E1: Dose Expansion | EXPERIMENTAL | Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab every 6 weeks (Q6W) via IV infusion, and SoC chemotherapy every 3 weeks (Q3W) for up to 4 cycles during the perioperative and adjuvant phases. |
| Part E2: Dose Expansion | EXPERIMENTAL | Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab Q6W via IV infusion, and SoC chemotherapy Q3W for up to 4 cycles during the perioperative and adjuvant phases. |
| Part E3: Dose Expansion | EXPERIMENTAL | Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab Q3W via IV infusion, and SoC chemotherapy Q2W or Q3W for up to 4 cycles during the perioperative and adjuvant phases. |
| Name | Type | Description |
|---|---|---|
| mRNA-4157 | DRUG | Individualized Neoantigen Therapy |
| Pembrolizumab | BIOLOGICAL | Intravenous infusion |
| SoC Treatment | 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...
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