Table 4.
Trials testing immunotherapeutic agents in HER2+ disease.
| NCI Identifier | Phase | Recruitment | Setting | Subtype | Immunotherapies | Combined Treatments |
Target |
|---|---|---|---|---|---|---|---|
| NCT03241173 | I/II | Active, not recruiting | Metastatic or LA |
All | Ipilimumab and/or nivolumab | INCAGN01949 | Anti-CTLA4 |
| NCT03126110 | I/II | Active, not recruiting | Metastatic or LA | All | Ipilimumab and/or nivolumab | INCAGN01876 | Anti-CTLA5 |
| NCT03328026 | I/II | Recruiting | Metastatic or LA | All | Ipilimumab or pembrolizumab | SV-BR-1-GM, cyclophosphamide, and interferon inoculation | Anti-CTLA6 |
| NCT02129556 | I/II | Active, not recruiting | Metastatic | HER2+ resistant to H | Pembrolizumab | H | anti-PDL1; anti-PD1 |
| NCT01772004 | I | Active, not recruiting | Metastatic | HER2+ | Avelumab | H | Anti-PD1 |
| NCT03747120 | II | Recruiting | Neoadjuvant | HER2+ | Pembrolizumab | Neoadjuvant H + P + Pac |
Anti-PDL1 |
| NCT03523572 | I | Recruiting | Advanced | HER2+ | Nivolumab | Trastuzumab deruxtecan | Anti-PDL1; Anti-PD3 |
| NCT02649686 | I | Active, not recruiting | Metastatic | HER2+ | Durvalumab | H | Anti-PDL1; Anti-PD4 |
| NCT02924883 | II | Active, not recruiting | Metastatic | HER2+ | Atezolizumab | T-DM1 | Anti-PDL1; Anti-PD5 |
| NCT03125928 | II | Recruiting | Metastatic | HER2+ | Atezolizumab | Pac + H + P | Anti-PDL1; Anti-PD6 |
| NCT03620201 | I | Recruiting | Stage II–III | HER2+ | M7824 (anti-PD-L1 fusion protein) | Anti-PDL1; Anti-PD7 | |
| NCT05180006 | I | Recruiting | Neoadjuvant | HER2+ TNBC | Atezolizumab | H + P | Anti-PDL1 |
| NCT02336984 | I/II | Active, not recruiting | DCIS | HER2+ | HER2-pulsed DC1 | H + P | Vaccine |
| NCT02061423 | I | Active, not recruiting | Stage I–III | HER2+ | HER2-pulsed DC vaccine | Vaccine | |
| NCT03384914 | II | Recruiting | Stage I–III | HER2+ | DC1 vaccine | Vaccine | |
| NCT03387553 | I | Active, not recruiting | Stage II/III | HER2+ | DC1 vaccine | Vaccine | |
| NCT03113019 | I | Active, not recruiting | Stage II–IV | HER2+ TNBC | DC-based vaccine | Vaccine | |
| NCT03113019 | I | Active, not recruiting | Stage II–IV | HER2+ TNBC | DC-based vaccine | Vaccine | |
| NCT03630809 | II | Not yet recruiting | DCIS or inflammatory | HER2+ | HER2-pulsed DC1 | Vaccine | |
| NCT01376505 | I | Recruiting | Metastatic | HER2 1+, 2+, or 3+ by IHC | MVF-HER-2 (597–626)-MVF- HER-2 (266–296) peptide vaccine | Vaccine | |
| NCT03632941 | II | Recruiting | Metastatic | HER+ | VRP-HER2 immunizations plus pembrolizumab. | Vaccine |
T-DM1: trastuzumab-emtansine; Pac: paclitaxel; H: trastuzumab; P: pertuzumab; LA: locally advanced; DC: dendritic cells; IHC: immunohistochemistry; DCIS: ductal carcinoma in situ; TNBC: triple-negative breast cancer.