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mRNA-4359 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1a (Dose Escalation): mRNA-4359 Alone | EXPERIMENTAL | Adult participants with locally advanced or metastatic cancer will be administered mRNA-4359 at an applicable dose as monotherapy. |
| Arm 1b (Dose Confirmation): mRNA-4359 in Combination with Pembrolizumab | EXPERIMENTAL | Participants with locally advanced or metastatic, and checkpoint inhibitor (CPI) refractory melanoma or locally advanced or metastatic, and CPI refractory non-small-cell lung carcinoma (NSCLC) will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab. |
| Arm 1b (Melanoma Expansion Cohort): mRNA-4359 in Combination With Pembrolizumab | EXPERIMENTAL | Participants 18 years or older with CPI refractory, advanced/metastatic melanoma with a programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) of ≥1% who have had progression on at least 1 prior CPI-based systemic therapy in the advanced/metastatic disease setting will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab. |
| Arm 2a (Dose Expansion): mRNA-4359 in Combination with Pembrolizumab | EXPERIMENTAL | Adult participants with locally advanced or metastatic melanoma who have not yet received any prior systemic therapy for their melanoma in this setting will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab. |
| Arm 2b (Dose Expansion): mRNA-4359 in Combination with Pembrolizumab | EXPERIMENTAL | Adult participants with locally advanced or metastatic NSCLC with a PD-L1 TPS of ≥50%, with no known epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive tumor mutations who have not yet received any prior systemic therapy for their NSCLC will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab. |
| Arm 2c (Dose Expansion): mRNA-4359 in Combination with Ipilimumab and Nivolumab | EXPERIMENTAL | Adult participants with locally advanced or metastatic melanoma who have not yet received any prior systemic therapy in this setting will be administered mRNA-4359 at an applicable dose in combination with ipilimumab and nivolumab. |
| Arm 2d (Dose Expansion): mRNA-4359 in Combination with Pembrolizumab | EXPERIMENTAL | Participants 12 years or older with CPI refractory, advanced/metastatic melanoma with a PD-L1 TPS of ≥1% who have had progression on at least 1 prior CPI-based systemic therapy in the advanced/metastatic disease setting will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab. |
| Pharmacodynamic (PD) Arm (Group 1): mRNA-4359 in Combination with Pembrolizumab | EXPERIMENTAL | Participants with locally advanced or metastatic, and CPI refractory melanoma will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab. |
| PD Arm (Group 2): mRNA-4359 in Combination with Pembrolizumab | EXPERIMENTAL | Participants with locally advanced or metastatic, and CPI refractory NSCLC with a PD-L1 TPS ≥1% will be administered mRNA-4359 at an applicable dose in combination with pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| mRNA-4359 | BIOLOGICAL | Intramuscular Injection |
| Pembrolizumab | BIOLOGICAL | Intravenous infusion |
| Ipilimumab | BIOLOGICAL | Intravenous infusion |
| Nivolumab | BIOLOGICAL | Intravenous infusion |
Key Inclusion Criteria: * Males or females ≥18 years of age who have provided written informed consent prior to completing any study-specific procedure. For Arm 2d, participants ≥12 years are eligible with informed consent/assent. * Dose Escalation (Arm 1a): Participant has histologically confirmed...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
mRNA-4359 is an investigational RNA therapy being studied for the treatment of advanced solid tumors. It is being evaluated in patients with advanced solid tumors, including in combination with immune checkpoint blockade. It is not approved for any indication and remains in clinical development.
mRNA-4359 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating the candidate in advanced solid tumors.
mRNA-4359 is in Phase 1 clinical development. The program is investigational and has not been approved by the FDA or any other regulatory authority. The single Phase 1 trial is currently recruiting participants.
mRNA-4359 is being studied in the Phase 1 trial NCT05533697, titled a study of mRNA-4359 administered alone and in combination with immune checkpoint blockade in participants with advanced solid tumors. The trial is recruiting, with an estimated enrollment of 361 participants across the United States, Australia, Germany, Italy, Poland, Spain, and the United Kingdom.
Yes, the mRNA-4359 Phase 1 trial NCT05533697 uses biomarker-based selection for enrollment. The study enrolls participants with advanced solid tumors and includes a controlled design, though it is not randomized or double blinded. Participants must be at least 12 years of age.