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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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
mRNA-4359 is an investigational therapy being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial that includes participants with advanced solid tumors.
mRNA-4359 is being developed by Moderna, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol MRNA. The company is conducting a Phase 1 clinical trial of the drug in patients with advanced solid tumors.
mRNA-4359 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The ongoing Phase 1 trial is recruiting participants with advanced solid tumors to evaluate the drug's safety and efficacy.
mRNA-4359 is being studied in a Phase 1 clinical trial registered as NCT05533697. The trial is titled 'Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors' and is currently recruiting participants in the United States, Australia, Germany, Italy, Poland, Spain, and the United Kingdom.
Yes, mRNA-4359 is being studied both alone and in combination with immune checkpoint blockade in a Phase 1 clinical trial for advanced solid tumors. The trial is designed to evaluate the drug's safety and efficacy in these treatment settings.