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. 2022 Jun 20;12:919072. doi: 10.3389/fonc.2022.919072

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.