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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04215146 | A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study | PHASE2 | ACTIVE NOT_RECRUITING | 48 | — | — | Jun 10, 2020 | Jun 1, 2025 | Jan 16, 2025 | 18 | United States |
Overall response rate at week 16 according to RECIST V1.1
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | ACTIVE_COMPARATOR | Patients receive paclitaxel alone. |
| Cohort 2 | EXPERIMENTAL | Patients receive pelareorep + paclitaxel. |
| Cohort 3 | EXPERIMENTAL | Patients receive pelareorep + paclitaxel + avelumab. |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle. |
| Pelareorep | BIOLOGICAL | Pelareorep 4.5 x 10\^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle. |
| Avelumab | DRUG | Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle. |
Inclusion Criteria: 1. Female patients ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Must have a histological/cytological diagnosis of breast cancer. Disease must be: * Positive for estrogen receptor (ER) and/or progesterone receptor (PgR) as defined by ≥ 1%...