Table 1.
(B) Clinical trials using PD1/PD-L1 antibodies in TNBC.
| Treatment | Clinical trial ID | Intervention | Phase Trial stage | Related results | Disease setting | |
|---|---|---|---|---|---|---|
| Monotherapy | PD1/PD-L1antibody |
NCT01848834 NCT02447003 NCT02555657 NCT02981303 NCT03197389 |
Pembrolizumab Pembrolizumab Pembrolizumab vs chemotherapy Pembrolizumab Pembrolizumab |
I Completed II Completed III Active II Completed I Completed |
ORR 18. 5 % ORR 5.7%;PFS 2.0mths; OS 9.0 mths, fifirst line setting:ORR 21.4%; PFS 2.1 mths; OS 18.0 mths No difference in PFS and OS No Results Posted Not Specified |
recurrent or metasttatic metasttatic metasttatic metasttatic Early stage |
|
NCT01375842 NCT03281954 NCT01772004 NCT02926196 NCT02489448 |
Atezolizumab Atezolizumab Avelumab Avelumab Durvalumab |
I Completed III Recruiting I Completed III active I/II Completed |
ORR 6% (12 vs 0%*): OS (10.1 vs 6.0 mths*), fifirst line setting:ORR 24%; OS 17.6 mths; ORR 5.2%(22.2 vs 2.6**) / Not Specified / No Results Posted |
metasttatic recurrent or metastatic recurrent or metastatic recurrent or metastatic recurrent or metastatic |
||
| PD1/PD-L1 antibody + Chemotherapy |
NCT02819518 NCT02755272 NCT02513472 NCT01042379 NCT02622074 NCT03036488 NCT02499367 |
Pembrolizumab + Nab-paclitaxel or Paclitaxel or Gemcitabine/Carboplatin Pembrolizumab + Gemcitabine/Carboplatin Pembrolizumab + Eribulin mesylate neoadjuvant Pembrolizumab + Paclitaxel, followed by AC, neoadjuvant Pembrolizumab + cxhemotherapy combination, (Nab-paclitaxel, Paclitaxel, Doxorubicin, Cyclophosphamide, Carboplatin) neoadjuvant Pembrolizumab + Paclitaxel-Carboplatin followed by adjuvant Pembrolizumab Cyclophosphamide, Cisplatin or Doxorubicin followed by Nivolumab |
III Active II Recruiting I/II Completed II Recruiting I Completed III Active II Active |
first line setting: PFS 9.7 mths / ORR 25.6%; PFS 4.1 mths / first line setting: pCR 60% first line setting: pCR 64.8% ORR 35 % (doxorubicin), first line setting: ORR 17% |
locally advanced, metastatic metastatic metastatic locally advanced, metastatic locally advanced locally advanced metastatic |
|
|
NCT01633970 NCT02425891 NCT03125902 NCT03371017 NCT02620280 NCT03197835 NCT03281954 NCT03498716 NCT03164993 NCT00856492 NCT02685059 |
Atezolizumab + Nab-paclitaxel Atezolizumab + Nab-paclitaxel Atezolizumab + Paclitaxel Atezolizumab + Gemcitabine/Carboplatin or Capecitabine Neoadjuvant Atezolizumab + Nab-paclitaxel + Carboplatin, followed by AC or EC or FEC Neoadjuvant Atezolizumab + Nab-paclitaxel, followed by AC Neoadjuvant Atezolizumab + Paclitaxel + Carboplatin, followed by adjuvant Atezolizumab + Paclitaxel, followed by Atezolizumab + AC or EC Atezolizumab + Pegylated liposomal doxorubicin + Cyclophosphamide Durvalumab + Cyclophosphamide + Doxorubicin hydrochloride + Paclitaxe Neoadjuvant Durvalumab + Nab paclitaxel + EC |
I Completed III Completed III Active III Recruiting III Active III Active III Recruiting III Recruiting II Recruiting II Completed II Completed |
ORR 39.4%:PFS 5.5 mths First line setting: OR 53%; OS 25 mths / / / pCR 57.6% / / / Not Specefied pCR 53% |
locally advanced, metastatic locally advanced, metastatic locally advanced, metastatic locally advanced, metastatic larly high risk, locally advance early stage early stage locally advanced locally advanced locally advanced early stage |
||
| Combination | PD1/PD-L1 antibody + Targeted therapy |
NCT02657889 NCT04683679 NCT03106415 NCT03797326 NCT02834247 NCT02849496 NCT02322814 NCT03971409 NCT03167619 NCT03801369 NCT02484404 NCT02734004 |
Pembrolizumab + Niraparib Pembrolizumab + Olaparib Pembrolizumab + MEKi Pembrolizumab + Lenvatinib Nivolumab + TAK-659 Atezolizumab + Olaparib Atezolizumab + Taxanes + MEKi Avelumab + MEKi Durvalumab + Olaparib Durvalumab + Olaparib Durvalumab + Olaparib +/-VEGFRi Durvalumab + Olaparib +/-VEGFR |
I/II Completed II Recruiting I/II Active II Active I Completed II Suspended II Completed II Recruiting II Active II Recruiting I/II Recruiting I/II Completed |
ORR 29% (67% #) / / / Not Specified / ORR 29-34% / / / / Not Specified |
locally advanced or metastatic metastatic or recurrent locally advanced or metastatic metastatic metastatic locally advanced or metastatic metastatic or locally advanced metastatic or locally advanced locally advanced or metastatic metastatic metastatic or recurrent advance or metastatic |
| PD1/PD-L1 antibody + NK cell |
NCT04551885 NCT03387085 |
Avelumab + FT-516 Avelumab + haNK + IL-15 + vaccine +chemoradiation |
I Active I/II Active |
/ ORR 67%; PFS(13.7 mths) |
locally advanced or metastatic metastatic or unresectable |
|
| PD1/PD-L1 antibody + vaccine |
NCT03362060 NCT02432963 NCT03761914 |
Pembrolizumab+ PVX-410 Pembrolizumab+p53-specifific vaccine Pembrolizumab+WT1-specifific vaccine |
I Active I Active I Active |
/ / / |
metastatic or unresectable advanced or unresectable advanced or metastatic |
|
|
NCT03289962 NCT02826434 NCT03199040 NCT03606967 |
Atezolizumab neoantigen vaccine Durvalumab+PVX-410 Durvalumab+neoantigen DNA vaccine Durvalumab + Nab-paclitaxel + neoantigen vaccine |
I Active I Active I Active II Recruiting |
/ / / / |
locally advanced or metastatic locally advanced metastatic metastatic |
||
| PD1/PD-L1 antibody + OPs | NCT01986426 | Pembrolizumab+LTX-315 | I Completed | Not Specified | metastatic or unresectable |
ORR,overall response rate; OS, overall survival; PFS progression free survival; pCR, pathological complete response;
*PD-L1 cutoff 1%; **PD-L1 cutoff 10%; #BRCA mutant.
AC, doxorubin + cyclophosphamide; EC, epirubicin + cyclophosphamide: FEC, flflurouracil + epirubicin + cyclophosphamide; MEKi, MEK inhibitors; VEGFRi, VEGFR inhibitors; PVX-140, multi-peptide vaccine (XBP1 US184-192: XBP1 SP367-375; CD138260)
FT-156, iPSC-derived NK cells with hnCD16; IL-15, interleukin 15; NK, natural killer cell; POs, Oncolytic peptides.