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Also known as TPIV200
Low dose FRα vaccine · 1 trial · 1 indication
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....
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Low dose FRα vaccine is an investigational cancer vaccine developed by Marker Therapeutics, Inc. (ticker MRKR) for breast cancer. It is a vaccine modality studied in a Phase 2 clinical trial in patients with triple negative breast cancer. It is not an approved therapy and remains in clinical development.
Low dose FRα vaccine is being studied for use in breast cancer, specifically in patients with triple negative breast cancer. The Phase 2 trial enrolled 80 female patients aged 18 years and older in the United States. It is an investigational product and has not been approved for any indication.
Low dose FRα vaccine is developed by Marker Therapeutics, Inc., which trades under the ticker MRKR. The company is the sponsor of the clinical program evaluating this vaccine in breast cancer.
Low dose FRα vaccine is in Phase 2 development. The Phase 2 trial, NCT02593227, has been completed. The vaccine is investigational and has not received FDA approval.
Low dose FRα vaccine has been studied in one clinical trial, NCT02593227, titled Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer. This Phase 2 trial was completed and enrolled 80 patients in the United States.
Yes, the Phase 2 trial NCT02593227 for low dose FRα vaccine was randomized and controlled. It was not double blind. The trial enrolled 80 female patients with triple negative breast cancer and has been completed.