Table 2.
List of completed or ongoing clinical trials with immune checkpoint inhibitors alone or with combinational drugs and novel immune-modulating strategies for early TNBC treatment.
| NCT | Anti PD-1/PD-L1 | Non-IT Drugs | IT Drugs | Compartor Arms | Experimental Arms | Phase | Primary Endpoints | Status |
|---|---|---|---|---|---|---|---|---|
| NCT04427293 | Pembrolizumab | Lenvatinib | Lenvatinib + Pembrolizumab |
I | Effectiveness | Recruiting | ||
| NCT03639948 | Pembrolizumab | Carboplatin Docetaxel |
Pembrolizumab + CT | II | pCR rate | Recruiting | ||
| NCT04373031 | Pembrolizumab | Epirubicin Cyclophosphamide Taxanes |
IRX-2 | Pembrolizumab+ CT |
Pembrolizumab + IRX-2 + CT | II | pCR rate | Recruiting |
| NCT05203445 | Pembrolizumab | Olaparib | Olaparib + Pembrolizumab |
II | pathologically negative MRI-guided biopsy after 12 weeks of treatment |
Recruiting | ||
| NCT02954874 | Pembrolizumab | No treatment | Pembrolizumab | III | iDFS Severity of Fatigue Physical function |
Active not recruiting | ||
| NCT02957968 | Pembrolizumab | Decitabine Doxorubicin Cyclophosphamide Paclitaxel Carboplatin |
Pembrolizumab + Decitabine Doxorubicin Cyclophosphamide Paclitaxel Carboplatin |
II | Dynamic of TILs | Recruiting | ||
| NCT05177796 | Pembrolizumab | Panitumumab Paclitaxel Carboplatin Doxorubicin Cyclophosphamide |
Panitumumab + Pembrolizumab + Paclitaxel + Carboplatin + Doxorubicin + Cyclophosphamide |
II | pCR Rate | Active not yet recruiting | ||
| NCT03036488 | Pembrolizumab | Carboplatin Paclitaxel Doxorubicin/Epirubicin Cyclophosphamide |
Placebo+ Carboplatin Paclitaxel Doxorubicin Epirubicin Cyclophosphamide |
Pembrolizumab + CBDCA Paclitaxel Doxorubicin/Epirubicin Cyclophosphamide |
III | pCR Rate EFS |
Active, not recruiting | |
| NCT01986426 | Pembrolizumab | LTX-315 | LTX-315 + Pembrolizumab |
I | DLT | Completed | ||
| NCT03197935 | Atezolizumab | Nab-paclitaxel Doxorubicin Cyclophosphamide |
Placebo+ Nab-paclitaxel+ Doxorubicin+ Cyclophosphamide |
Atezolizumab + Nab-paclitaxel Doxorubicin + Cyclophosphamide |
III | pCR in ITT pCR in PD-L1+ |
Completed | |
| NCT03498716 | Atezolizumab | Paclitaxel Dose-dense Doxorubicin/Epirubicin Cyclophosphamide |
Placebo+ Paclitaxel+ Dose-dense Doxorubicin or Epirubicin+ Cyclophosphamide |
Atezolizumab + Paclitaxel Dose-dense Doxorubicin/Epirubicin Cyclophosphamide |
III | iDFS | Recruiting | |
| NCT03371017 | Atezolizumab | Gemcitabine Capecitabine Carboplatin |
Placebo+ Gemcitabine+ Capecitabine+ Carboplatin |
Atezolizumab + Gemcitabine + Capecitabine + Carboplatin |
III | OS | Recruiting | |
| NCT03256344 | Atezolizumab | Talimogene laherparepvec | Talimogene + Laherparepvec + Atezolizumab |
I | DLTs | Completed | ||
| NCT04102618 | Atezolizumab | Pelareorep | Atezolizumab + Pelareorep |
I | CelTIL Score | Recruiting | ||
| NCT03356860 | Durvalumab | Paclitaxel Epirubicin Cyclophosphamide |
Paclitaxel+ Epirubicin+ Cyclophosphamide |
Durvalumab + Paclitaxel Epirubicin + Cyclophosphamide |
I/II | pCR Rate Safety |
Recruiting | |
| NCT05209529 | Durvalumab | Olaparib | Durvalumab + Olaparib Olaparib monotherapy |
II | pCR Rate | Recruiting | ||
| NCT02489448 | Durvalumab | Nab-paclitaxel Doxorubicin Cyclophosphamide |
Durvalumab + Nab-paclitaxel Doxorubicin + Cyclophosphamide |
I/II | pCR Rate | Active not recruiting | ||
| NCT03740893 | Durvalumab | AZD6738 Olaparib |
Standard CT | AZD6738 monotherapy Olaparib monotherapy Durvalumab monotherapy |
II | Safety Immunomodulating action |
Recruiting | |
| NCT03594396 | Durvalumab | Olaparib | Durvalumab + Olaparib |
I/II | Changes in tumor biology | Active not recruiting | ||
| NCT02685059 | Durvalumab | Nab-Paclitaxel Epirubicin Cyclophosphamide |
Placebo+ Nab-Paclitaxel Epirubicin Cyclophosphamide |
Durvalumab + Nab-Paclitaxel Epirubicin + Cyclophosphamide |
II | pCR Rate | Completed | |
| NCT01042379 | Pembrolizumab Cemiplimab Dostarlimab Durvalumab |
AMG 386 Trastuzumab AMG 479 (Ganitumab) Metformin MK-2206 AMG 386 T-DM1 Pertuzumab and Trastuzumab Ganetespib ABT-888 Neratinib PLX3397 Talazoparib Irinotecan Patritumab SGN-LIV1A Olaparib SD-101 Tucatinib REGN3767 Trilaciclib Paclitaxel Encequidar Carboplatin Oral Paclitaxel |
Standard Treatments depending on HR/HER2-status | Experimental agents added to standard neoadjuvant treatment | II | pCR rate | Recruiting | |
| NCT04613674 | Camrelizumab | Standard CT | Placebo+ Standard CT |
Camrelizumab + Standard CT |
III | pCR Rate | Recruiting | |
| NCT04301739 | HLX 10 | Nab-Paclitaxel Carboplatin Doxorubicin Cyclophosphamide |
Placebo+ Nab-Paclitaxel Carboplatin Doxorubicin Cyclophosphamide |
HLX 10 + Nab-Paclitaxel + Carboplatin Doxorubicin + Cyclophosphamide |
III | pCR Rate | Not yet recruiting | |
| NCT03815890 | Nivolumab | Ipilimumab | Nivolumab Nivolumab + Ipilimumab |
II | Immune activation after pre-operative Nivolumab | Recruiting | ||
| NCT03487666 | Nivolumab | Capecitabine | Capecitabine | Nivolumab Nivolumab + Capecitabine |
II | Immune activation measured by changes in the peripheral immunoscore (PIS) at week 6 | Active not recruiting | |
| NCT03818685 | Nivolumab | Capecitabine | Ipilimumab | Capecitabine | Nivolumab + Ipilimumab |
II | iDFS | Recruiting |
| NCT04185311 | Nivolumab | Ipilimumab+ Talimogene laherparepvec |
Talimogene laherparepvec + Nivolumab + Ipilimumab |
I | Safety | Active not recruiting | ||
| NCT02938442 | Doxorubicin Cyclophosphamide Paclitaxel | P10s-PADRE with MONTANIDE™ ISA 51 VG | Doxorubicin + Cyclophosphamide Paclitaxel | P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel |
I/II | Safety pCR Rate |
Recruiting | |
| NCT02779855 | Paclitaxel | Talimogene laherparepvec | Talimogene laherparepvec + Paclitaxel |
I/II | MTD RP2D pCR Rate |
Active not recruiting |
CT, chemotherapy; pCR, pathological complete response; MRI, magnetic resonance imaging; iDFS, invasive disease-free survival; TILs, tumor-infiltrating lymphocytes; EFS, event free survival; DLTs, dose-limiting toxicity; ITT, intention-to treat; OS, overall survival; MTD, maximum tolerated dose; RP2D, recommended phase 2 dose.