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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02593227 | Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer | PHASE2 | COMPLETED | 80 | — | — | Apr 1, 2016 | Jul 15, 2021 | Jul 19, 2021 | 11 | United States |
Emergence of B and T cell immunity targeting the folate receptor alpha
| Arm | Type | Description |
|---|---|---|
| Low dose FRα vaccine | EXPERIMENTAL | FRα peptide vaccine with GM-CSF adjuvant - single ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence |
| High dose FRα vaccine | EXPERIMENTAL | FRα peptide vaccine with GM-CSF adjuvant - triple ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence |
| Low dose FRα vaccine + cyclophosphamide | EXPERIMENTAL | Cyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRα peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence |
| High dose FRα vaccine + cyclophosphamide | EXPERIMENTAL | Cyclophosphamide 300 mg/sqm as a 1 hour IV infusion 3 days prior to first vaccination. Followed by FRα peptide vaccine with GM-CSF adjuvant - ID administration - monthly vaccinations repeated 6 times followed by boosters every 6 months until recurrence |
| Name | Type | Description |
|---|---|---|
| Low dose FRα vaccine | BIOLOGICAL | 165ug per peptide ID injection |
| Cyclophosphamide | DRUG | IV infusion over 1 hour |
| High dose FRα vaccine | BIOLOGICAL | 500ug per peptide ID injection |
Inclusion Criteria: 1. Female patient, age 18 years or older; 2. Completely resected unilateral or bilateral primary carcinoma of the breast 3. Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures; 4....