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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05933577 | A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001) | PHASE3 | ACTIVE NOT_RECRUITING | 1,089 | — | — | Jul 19, 2023 | Sep 26, 2030 | Sep 24, 2025 | 165 | United States, Argentina +24 |
RFS is defined as the length of time from when the participant starts the study until either the cancer comes back, or the cancer spreads as assessed by the investigator, or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Intismeran autogene + Pembrolizumab | EXPERIMENTAL | Participants receive up to 9 doses of intismeran autogene via an intramuscular (IM) injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an intravenous (IV) infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner. |
| Placebo + Pembrolizumab | ACTIVE_COMPARATOR | Participants receive up to 9 doses of dose matched placebo to intismeran autogene via an IM injection (every 3 weeks) plus up to 9 doses of pembrolizumab via an IV infusion (once every 6 weeks) until disease recurrence or unacceptable toxicity, or for a total treatment duration of up to approximately 56 weeks, whichever is sooner. |
| Name | Type | Description |
|---|---|---|
| Intismeran autogene | BIOLOGICAL | IM injection |
| Pembrolizumab | BIOLOGICAL | IV infusion |
| Placebo | OTHER | IM injection |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has surgically resected and histologically/pathologically confirmed diagnosis of Stage IIB or IIC, III, or IV cutaneous melanoma * Has not received any prior systemic therapy for their melanoma beyond s...