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Table 3 Ongoing trials with immunotherapy in HER2 + metastatic breast cancer patients

From: Immunotherapy in HER2-positive breast cancer: state of the art and future perspectives

 

Drug

Phase

Setting

Status

Type of intervention

Mechanism of action

NCT02492711 [91]

Margetuximab

III

Metastatic

Completed

HER2-block enhancer

Increased ADCC effect

NCT03330561 [96]

PRS-343

I

Metastatic

Recruiting

Immune costimulatory

T-Cell activation

NCT03650348 [97]

PRS-343+

Atezolizumab

I

Metastatic

Recruiting

Immune costimulatory+

Immune check point inhibitor

T-Cell activation+

Anti PD-L1

NCT02829372 [98]

NA

I

Metastatic

Recruiting

Immune costimulatory (anti HER2/ CD-3 antibody)

ADCC +

T-Cell activation

NCT02627274 [100]

RO6874281

I

Metastatic

Recruiting

Immune costimulatory

ADCC +

T-Cell activation

DIAmOND [101]

Durvalumab+

Tremelimumab+

Trastuzumab

II

Metastatic

Recruiting

Immune check point inhibitor

Anti PD-L1 + Anti-CTLA-4

NCT03414658 [102]

Avelumab + Utomilumab +

Vinroelbine+

Trastuzumab

II

Metastatic

Recruiting

Immune costimulatory+

Immune check point inhibitor

T-Cell activation+

Anti PD-1

NCT03199885 [103]

Paclitaxel + Trastuzumab + Pertuzumab + Atezolizumab

III

Metastatic

Recruiting

Immune check point inhibitor

Anti PD-L1

NCT02297698 [104]

Nelipepimut+

Trastuzumab

II

Metastatic

Active, not recruiting

Vaccine

Peptide-based vaccine (E75)

NCT00266110 [105]

therapeutic autologous dendritic cells+ Trastuzumb + Chemotherapy

II

Metastatic

Completed

Vaccine

DC vaccine

NCT02713984 [106]

Anti-HER2 CAR-T

I

Metastatic

Recruiting

Vaccine

CAR-T cells

NCT03125928 [107]

Pertuzumab + Trastuzumab + Atezolizumab

IIA

Metastatic

Recruiting

Immune check point inhibitor

Anti PD-L1

NCT02605915 [108]

Atezolizumab+ Pertuzumab + Trastuzumab + or Atezolizumab+TDM-1

IB

Early and metastatic

Active, not recruiting

Immune check point inhibitor

Anti PD-L1

NCT03417544 [109]

Atezolizumab+Pertuzumab + Trastuzumab +

II

Metastatic

Recruiting

Immune check point inhibitor

Anti PD-L1

NCT00343109 [110]

NA

II

Metastatic

Active, not recruiting

Vaccine

ICD peptide-based vaccine

NCT02547961 [111]

NA

I/II

Metastatic

Completed

Vaccine

CAR-T cells

NCT03364348 [112]

Utomilumab + TDM-1 or trastuzumab

I

Metastatic

Recruiting

Immune costimulatory

T-Cell activation

NCT01922921 [113]

 

I/II

Metastatic

Active, not recruiting

Vaccine

ICD peptide-based vaccine

NCT03032107 [114]

Pembrolizumab+

TDM-1

I

Metastatic

Recruiting

Immune checkpoint inhibitor

Anti PD-1

NCT00436254 [115]

NA

I

Early and metastatic

Active, not recruiting

Vaccine

pNGVL3-hICD vaccine

NCT00194714 [116]

NA

I/II

Metastatic

Active, not recruiting

Vaccine

Her2+ peptide vaccine

NCT03740256 [117]

NA

I

Metastatic

Not yet recruiting

Vaccine

Adenovirus-specific cytotoxic T lymphocytes (HER2-AdVST), in combination with intra-tumor injection of CAdVEC, an oncolytic adenovirus

  1. mAbdirected against fibroblast activation protein-alpha (FAP) linked to an engineered, variant form of interleukin-2 (IL-2v)
  2. Only HER2+ patients with brain metastasis
  3. Abbreviations: ADCC antibody-dependent cytotoxic cell, CAR chimeric antigen receptor, DC dendritic cell, ICD intracellular domain, mAb monoclonal antibody, NA not available