Table 2.
Current and completed clinical trials of immune checkpoint inhibition in breast cancer.
| Immunotherapy | Subtype | Target | Combination | Study | Phase |
|---|---|---|---|---|---|
| Pembrolizumab | TNBC ER+/HER2- |
PD-1 | Single agent |
NCT02555657 KEYNOTE-119 [62] |
3 |
|
| |||||
| Pembrolizumab | BRCA mutated | PD-1 | Single Agent | NCT03025035 | 2 |
|
| |||||
| Pembrolizumab | TNBC ER+/HER2- |
PD-1 | Single agent |
NCT02447003 KEYNOTE-086 [63] |
2 |
|
| |||||
| Pembrolizumab | TNBC ER+/HER2- |
PD-1 | Single agent |
NCT01848834 KEYNOTE-012 [64] |
1B |
|
| |||||
| Pembrolizumab | TNBC ER+/HER2- |
PD-1 | Single agent |
NCT02054806 KEYNOTE-028 [65] |
1 |
|
| |||||
| Pembrolizumab | ER/PR- | PD-1 | Single Agent | NCT03197389 | 1 |
|
| |||||
| Pembrolizumab | TNBC and HR+HER2- |
PD-1 | Decitabine + Soc NACT | NCT02957968 | 2 |
|
| |||||
| Pembrolizumab | TNBC | PD-1 | EDP1503 | NCT03775850 | 2 |
|
| |||||
| Pembrolizumab | TNBC | PD-1 | Imprime PGG | NCT02981303 | 2 |
|
| |||||
| Pembrolizumab | HR+HER2- | PD-1 | Eribulin |
NCT03222856 KELLY [66] |
2 |
|
| |||||
| Pembrolizumab | TNBC | PD-1 | Chemotherapy |
NCT01042379 I-SPY 2 [64, 67] |
2 |
|
| |||||
| Pembrolizumab | TNBC | PD-1 | Galinpepimut-S | NCT03761914 | 2 |
|
| |||||
| Pembrolizumab | TNBC | PD-1 | Nab-paclitaxel + Epirubicin + Cyclophosphamide |
NCT03289819 | 2 |
|
| |||||
| Pembrolizumab | TNBC | PD-1 | Chemotherapy |
NCT02622074 KEYNOTE-173 [68] |
1B |
|
| |||||
| Pembrolizumab | ER+HER2- / TNBC | PD-1 | Radiation Radiation |
NCT03366844 | 1 |
|
| |||||
| Pembrolizumab | Metastatic BC | PD-1 | High Intensity Ultrasound | NCT03237572 | 1 |
|
| |||||
| Pembrolizumab | All | PD-1 | Stereotactic Ablative Radiosurgery |
NCT02303366 BOSTON II |
1 |
|
| |||||
| Pembrolizumab | TNBC | PD-1 | PVX-410 vaccine | NCT03362060 | 1 |
|
| |||||
| PDR001 | TNBC | PD-1 | Canakinumab CJM112 Trametinib EGF816 |
NCT02900664 | 1B |
|
| |||||
| PDR001 | TNBC | PD-1 | LCL161 Everolimus Panobinostat QBM076 |
NCT02890069 | 1 |
|
| |||||
| PDR001 | TNBC | PD-1 | NZV930 NZV930 + NIR178 |
NCT03549000 | 1 |
|
| |||||
| Durvalumab | TNBC | PD-L1 | Single agent Taxane-anthracycline chemotherapy |
NCT02685059 GeparNuevo [69] |
2 |
|
| |||||
| Durvalumab +/- Tremelimumab | All | PD-L1 +/- CTLA-4 | Poly ICLC | NCT02643303 | 2 |
|
| |||||
| Durvalumab | BRCA mutated HER2- | PD-L1 | Olaparib +Bevacizumab |
NCT02734004 MEDIOLA [70] |
2 |
|
| |||||
| Durvalumab | TNBC | PD-L1 | Paclitaxel and Carboplatin |
NCT03616886 SYNERGY |
2 |
|
| |||||
| Durvalumab | BRCA mutated HER2- | PD-L1 | Olaparib |
NCT02734004 MEDIOLA [70] |
1 |
|
| |||||
| Durvalumab | TNBC | PD-L1 | Paclitaxel, Carboplatin and Oleclumab |
NCT03616886 SYNERGY |
1 |
|
| |||||
| Durvalumab | TNBC | PD-L1 | Cediranib Olaparib Cediranib + Olaparib |
NCT02484404 | 1 |
|
| |||||
| Atezolizumab | TNBC | PD-L1 | Single agent | NCT01375842 [71] | 1 |
|
| |||||
| Atezolizumab | TNBC | PD-L1 | Nab-paclitaxel |
NCT02425891 IMpassion130 [14] |
3 |
|
| |||||
| Atezolizumab | HER2+ | PD-L1 | Trastuzumab Emtansine |
NCT02924883 KATE2 [72] |
2 |
|
| |||||
| Atezolizumab | TNBC | PD-L1 | Cabozantinib | NCT03170960 | 1B |
|
| |||||
| Atezolizumab | TNBC | PD-L1 | RO7198457 | NCT03289962 | 1 |
|
| |||||
| Nivolumab | TNBC | PD-L1 | Romidepsin + Cisplatin | NCT02393794 | 2 |
|
| |||||
| Nivolumab | TNBC | PD-L1 | Capecitabine |
NCT03487666 OXEL [73] |
2 |
|
| |||||
| Nivolumab | Metastatic | PD-L1 | Nab-paclitaxel | NCT02309177 | 1 |
|
| |||||
| Nivolumab | All | PD-L1 | COM701 | NCT03667716 | 1 |
|
| |||||
| Avelumab | TNBC | PD-L1 | Additional |
NCT02926196 A-Brave [74] |
3 |
|
| |||||
| Avelumab | TNBC | PD-L1 | Utomilumab |
NCT02554812 JAVELIN [75] |
2 |
|
| |||||
| Avelumab | All | PD-L1 | Utomilumab +/- Radiation Utomilumab + PF-04518600 PF-04518600 +/- Radiation Utomilumab + PF-04518600 + Radiation Cisplatin + Radiation |
NCT03217747 | 2 |
|
| |||||
| FAZ053 | TNBC | PD-L1 | Single Agent PDR001 |
NCT02936102 | 1 |
|
| |||||
| LY3300054 | HR+HER2- | PD-L1 | Single Agent Ramucirumab Abemaciclib Merestinib LY3321367 |
NCT02791334 | 1 |
|
| |||||
| Tremelimumab | TNBC | CTLA-4 | Monotherapy | NCT02527434 [76] | 2 |
|
| |||||
| MSB0011359C | ER+ and/or PR+, HER2- | PD-L1 and TGF-β | Radiation |
NCT03524170 RACHEL 1 |
1 |
|
| |||||
| LAG525 | TNBC | LAG3 | Single agent PDR001 / Carboplatin or combination |
NCT03499899 | 2 |
|
| |||||
| Toripalimab | TNBC | PD-1 | Single Agent | NCT02838823 | 1 |
|
| |||||
| TT1-621 | All | CD47 | Single Agent +PD1/PDL1 inhibitor +Pegylated interferon- α2a +T-Vec +Radiation |
NCT02890368 | 1 |
|
| |||||
| Ipilimumab + Nivolumab |
HER2- | CTLA-4 PD-1 |
Bicalutamide | NCT03650894 | 2 |
|
| |||||
| Ipilimumab + Nivolumab |
HER2- | CTLA-4 PD-1 |
__ |
NCT03789110 NIMBUS |
2 |
|
| |||||
| Epacadostat + Pembrolizumab | All | IDO-1 PD-1 |
INCAGN01876 (anti-GITR) | NCT03277352 | 1/2 |
|
| |||||
| Ipilimumab + Nivolumab | All | PD-1 PD-L1 |
Entinostat | NCT02453620 | 1 |
|
| |||||
| Nivolumab + Pembrolizumab + Atezolizumab | HER2+ | PD-L1 PD-1 PD-L1 |
FT500 (Natural Killer cell) | NCT03841110 | 1 |
|
| |||||
| Ipilimumab + Nivolumab | All | CTLA-4 + PD-L1 | Cryoablation | NCT02833233 [77] | N/A |