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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05533697 | Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 361 | — | — | Sep 1, 2022 | Feb 18, 2032 | May 28, 2026 | 31 | United States, Australia +3 |
| 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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |