Table 3.
Cancer vaccines in TNBC, based on unpublished data (registered trials). Non-randomized trials are marked with asterisks.
| Vaccine Name | Trial ID | Phase | Platform | Target Antigen | Adjuvant | Co-Therapies | Disease Stage | Primary Outcome(s) | Status |
|---|---|---|---|---|---|---|---|---|---|
| AE37 | NCT04024800 | 2 | Peptide | HER2 1 | GM-CSF 2 | Pembrolizumab | IV | Recommended dose, ORR 3 | Active, not recruiting |
| Galinpepimut-S | NCT03761914 | 1/2 | Peptide | WT1 4 | N/S 5 | Pembrolizumab | IV | Safety, ORR, CRR 6 | Active, not recruiting |
| MUC1 7 vaccine | NCT00986609 | 1 | Peptide | MUC1 7 | Poly-ICLC | - | I-III | IR 8 | Completed |
| CDX-1401 | NCT02661100 | 1/2 | Peptide | NY-ESO-1 9 | Poly-ICLC | Pembrolizumab | Advanced TNBC | DLT 10 | Withdrawn |
| P10s-PADRE | NCT02938442 | 1/2 | Peptide | GD2/LeY 11 | Montanide ISA 51 | NAC 12 (A 13 C 14 T 15) | I-III | Safety, pCR 16 | Recruiting |
| NGcGM3/VSSP | RPCEC00000218 | 1/2 | Peptide | NGcGM3 | VSSP 17 | Nimotuzumab | IV | OS 18 | Pending recruitment |
| FR-α 19 vaccine | NCT02593227 | 2 | Peptide | FR-α | GM-CSF | Cyclophosphamide | I-III | IR | Completed |
| NCT03012100 | 2 | Peptide | FR-α | GM-CSF | Cyclophosphamide | I-III | DFS 20 | Recruiting | |
| HER2/MUC1 vaccine | NCT00640861 | 1 | Peptide | HER2/MUC1 | CpG oligodeoxynucleotide, incomplete Freund’s adjuvant, sargramostim | - | II-III | IR, safety | Completed |
| Neoantigen long peptide vaccine | NCT02427581 | 1 | Peptide | Personalized neoantigens | Poly ICLC | - | e 21 TNBC | Safety, IR | Withdrawn |
| Apoptotic tumor cell-pulsed DC 22 vaccine | ChiCTR-IPR-15005955 | 1 | Dendritic Cell | Whole tumor cells | - | - | II-IV | IR, tumor markers, PFS 23 | Pending recruitment |
| HER2/HER3 24 loaded DC vaccine | NCT04348747 | 2 | Dendritic Cell | HER2, HER3 | - | Pembrolizumab | IV (brain metastases) | CNS 25 ORR | Recruiting |
| Neoantigen-pulsed DC vaccine | NCT04105582 | 1 | Dendritic Cell | Personalized neoantigens | - | - | N/S | Safety | Completed |
| NCT04879888 | |||||||||
| NANT cancer vaccine (NCV) | NCT03175666 * | 1/2 | DNA (Adenovirus/yeast) | CEA 26, MUC1, brachyury, and RAS | - | Avelumab, bevacizumab, N-803, chemotherapy, SBRT 27, haNK cells 28 | IV | Safety, ORR | Withdrawn |
| NCT03554109 | 2 | DNA (Adenovirus/yeast) | CEA, MUC1, brachyury, and RAS | Avelumab, N-803, chemotherapy, haNK cells | II/III | pCR | Withdrawn | ||
| PF-06936308 | NCT03674827 | 1 | DNA (Adenovirus) | 3 TAA 29s (non-disclosed) | - | - | IV | CBR 30, safety | Terminated |
| Polyepitope Neoantigen DNA Vaccine | NCT02348320 | 1 | DNA (Plasmid) | Personalized neoantigens | - | - | I-III | Safety | Completed |
| NCT03199040 | 1 | DNA (Plasmid) | Personalized neoantigens | - | Durvalumab | I-III | Safety | Active, not recruiting | |
| STEMVAC | NCT05455658 * | 2 | DNA (Plasmid) | CD105, Yb-1 31, SOX2, CDH3, MDM2 32 | - | GM-CSF | I-III | IR | Not yet recruiting |
1 HER2: human epidermal growth factor receptor 2; 2 GM-CSF: granulocyte-macrophage colony-stimulating factor; 3 ORR: objective response rate; 4 WT1: Wilm’s tumor 1; 5 N/S: not specified; 6 CRR: complete response rate; 7 MUC1: mucin-1; 8 IR: immune response; 9 NY-ESO-1: New York esophageal squamous cell carcinoma-1; 10 DLT: dose-limiting toxicity; 11 LeY: Lewis Y; 12 NAC: neoadjuvant chemotherapy; 13 A: doxorubicin; 14 C: cyclophosphamide; 15 T: paclitaxel; 16 pCR: pathological complete response; 17 VSSP: Very small size proteo-liposome; 18 OS: Overall survival; 19 FRα: Folate Receptor-α; 20 DFS: Disease-free survival; 21 e: early; 22 DC: dendritic cell; 23 PFS: progression-free survival; 24 HER3: human epidermal growth factor receptor 3; 25 CNS: central nervous system; 26 CEA: carcinoembryonic antigen; 27 SBRT: stereotactic body radiation therapy; 28 haNK cells: high-affinity natural killer cells; 29 TAA: tumor-associated antigen; 30 CBR: clinical benefit rate; 31 Yb-1: Y-box binding protein 1; 32 MDM2: Murine double minute 2.