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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03767348 | Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) | PHASE2 | ACTIVE NOT_RECRUITING | 340 | — | — | Sep 20, 2017 | Dec 1, 2028 | Feb 13, 2026 | 51 | United States, France +3 |
Percentage of subjects with adverse events (AEs)
Percentage of subjects with serious adverse events (SAEs)
Percentage of subjects with dose limiting toxicities (DLTs)
Percentage of overall response rate (ORR) for all participants
Assess the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of RP1 based on the safety and response data collected during Phase 1 Escalation
| Arm | Type | Description |
|---|---|---|
| Dose escalation of RP1 by intratumoral (IT) injection in superficial tumors | EXPERIMENTAL | anti-PD-1 monoclonal antibody |
| Dose escalation of RP1 by intratumoral (IT) injection in deep/visceral tumors | EXPERIMENTAL | Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors |
| Dose expansion of RP1 and nivolumab (IV) in superficial tumors | EXPERIMENTAL | Dose escalation of RP1 alone in 3 cohorts with IT injections in superficial tumors |
| Dose expansion of RP1 and nivolumab (IV) in deep/visceral tumors | EXPERIMENTAL | Doses of RP1 (IT) in deep/visceral tumors with nivolumab (IV) |
| RP1 (IT) and nivolumab (IV) in melanoma | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with melanoma |
| RP1 (IT) and nivolumab (IV) in MSI-H/dMMR solid tumors | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with MSI-H or dMMR solid tumors |
| RP1 (IT) and nivolumab (IV) in NMSC | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer |
| RP1(IT) and nivolumab (IV) in anti-PD1 Failed Cutaneous Melanoma | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with cutaneous melanoma who have been previously treated with anti-PD1 therapy |
| RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NMSC | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non-melanoma skin cancer who have been previously treated with anti-PD1/PD-L1 therapy |
| RP1(IT) and nivolumab (IV) in anti-PD1/PD-L1 Failed NSCLC | EXPERIMENTAL | Doses of RP1 (IT) in superficial or deep tumors with nivolumab (IV) in subjects with non small cell lung cancer who have been previously treated with anti-PD1/PD-L1 therapy |
| Name | Type | Description |
|---|---|---|
| RP1 | BIOLOGICAL | Genetically modified herpes simplex type 1 virus |
| nivolumab | BIOLOGICAL | anti-PD-1 monoclonal antibody |
Key Inclusion Criteria: * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * At least one measurable and injectable lesion * Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy * Have a predicted life expectancy of ≥...