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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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mRNA-4157 is an investigational RNA therapy being studied for the treatment of melanoma and other solid tumors. It is being developed as an adjuvant treatment for patients with high-risk melanoma, and is also being evaluated in solid tumor settings. It is not approved for any indication and remains in clinical development.
mRNA-4157 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. The company is advancing the asset in oncology, with melanoma and solid tumors as the lead indications. Development is currently at the Phase 2 stage.
mRNA-4157 is in Phase 2 clinical development. The lead study is a Phase 2 trial in high-risk melanoma, and a Phase 1 study has also been conducted in solid tumors. The drug is investigational and has not been approved by the FDA for any indication.
mRNA-4157 has been studied in two registered trials. NCT03897881, also known as KEYNOTE-942, is a Phase 2 efficacy study of adjuvant mRNA-4157 plus pembrolizumab in high-risk melanoma, enrolling 267 participants. NCT03313778 is a Phase 1 safety, tolerability, and immunogenicity study in solid tumors, enrolling 161 participants.
KEYNOTE-942, registered as NCT03897881, is a Phase 2 efficacy study of adjuvant treatment with the personalized cancer vaccine mRNA-4157 and pembrolizumab in participants with high-risk melanoma. It enrolled 267 participants across the United States and Australia, is active but not recruiting, and uses an active-controlled design.
No. mRNA-4157 is an investigational therapy and has not been approved by the FDA. It is currently in Phase 2 clinical development for melanoma and solid tumors, with the lead trial listed as active but not recruiting.