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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06072612 | Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. | PHASE3 | RECRUITING | 404 | — | — | Dec 5, 2023 | Jun 1, 2028 | Apr 7, 2026 | 79 | United States |
| NCT03328026 | Combination Study of SV-BR-1-GM With Retifanlimab | PHASE1 | COMPLETED | 36 | — | — | Mar 16, 2018 | Mar 24, 2026 | Mar 27, 2026 | 14 | United States |
To evaluate the effect of the Bria-IMT regimen in combination with Check Point Inhibitor (CPI) on overall survival (OS) compared to treatment of physician's choice (TPC) chemotherapy in patients with metastatic breast cancer with no approved alternative therapies available as per the Inclusion criteria.
To evaluate the safety of SV-BR-1-GM as assessed by: o Adverse Events (AEs), including Serious Adverse Events (SAEs)
To evaluate the safety of SV-BR-1-GM as assessed by: o The Proportion of Patients with Abnormalities in Safety Laboratory Parameters
To evaluate the safety of SV-BR-1-GM as assessed by: o Electrocardiograms (ECG) with measurement of the QT interval
| Arm | Type | Description |
|---|---|---|
| Bria-IMT Regimen + CPI | EXPERIMENTAL | The Bria-IMT regimen: Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site |
| Treatment of Physician's Choice | ACTIVE_COMPARATOR | TPC consists of eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine or taxanes in accordance with the investigators' and institutional standard of care. The specific details of the selected regimen must include every detail of administration including frequency, sequencing (for multi-agent regimens), duration of infusion or oral administration, planned dose, dose prescribed, dose administered, dose adjustments after initial prescription or start of TPC treatment, and any other change in TPC from its initial election prior to randomization. |
| Bria-IMT Regimen Alone | EXPERIMENTAL | The Bria-IMT regimen: Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site |
| SV-BR-1-GM, retifanlimab combination original sequence | EXPERIMENTAL | Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab with cycles every 3 weeks |
| SV-BR-1-GM, retifanlimab combination alternative sequence | EXPERIMENTAL | Subjects will be treated with the SV-BR-1-GM regimen in combination with retifanlimab as follows: Cycle 1: SV-BR-1-GM only Cycle 2: resume retifanlimab on Day 2±1 Cycle 3 and beyond: retifanlimab can be administered on Day -2, Day 0, 1, 2, or 3. |
| Name | Type | Description |
|---|---|---|
| SV-BR-1-GM | BIOLOGICAL | SV-BR-1-GM is an experimental, allogeneic, whole cell breast tumor cell line stably transfected with the CSF2 gene (encoding GM-CSF) to secrete GM-CSF in vivo to consequently augment dendritic cell activity |
| Cyclophosphamide | DRUG | Cyclophosphamide is an alkylating agent with indications for treatment of malignant diseases including breast cancer. Cyclophosphamide (Cytoxan) 300 mg/m2 I.V., single dose, will be given to patients assigned to the SV-BR-1-GM. Cyclophosphamide will be administered 2-3 days prior to SV-BR-1-GM inoculations. |
| Interferon infiltration of the inoculation site | DRUG | Interferon is a cytokine released by cells to regulate immune responses to viral infections. For this study, 0.1 mcg Pegasys per injection site (x 4 injection sites) will be administered. |
| Retifanlimab | DRUG | Retifanlimab is a checkpoint inhibitor. A total dose of 375mg will be administered at first cycle on or about day +2 (+/-1d). In all other cycles, Retifanlimab is permitted to be administered between Day -2/-3 to Day 2±1 of the cycle based on the convenience of the patients and the clinical sites. However once the timing of the CPI is chosen for C1, it must be given on the same day thereafter throughout the trial. |
| Treatment of Physician's Choice | DRUG | Patients in the TPC arm of the study will be treated with one or a combination of the following: carboplatin, taxanes, capecitabine, gemcitabine, vinorelbine or eribulin in accordance with the investigators and institutional standard of care. For HER2+ patients, a HER2-targeted agent of the physician's choice can be part of TPC. |
| Low dose cyclophosphamide | DRUG | Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation. |
| Interferon Inoculation | DRUG | Post-inoculation low dose Interferon into the vaccination sites \~2 days after SV-BR-1-GM inoculation. |
Inclusion Criteria: 1. Be ≥ 18 years of age. 2. Have signed informed consent. 3. Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy: * Patients with persistent disease and local recurrence must not ...