Table 6 Summary of clinical trials investigating the combination of ADCs and immunotherapy
From: The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors
Target | NCT number | Other names | Drug | Partner drugs | Partner drug category (target) | Phase | Start | Treatment setting | Efficacy |
|---|---|---|---|---|---|---|---|---|---|
HER2 | NCT02605915 [139] | Â NA | T-DM1 | Atezolizumab | IO | Ib | 2015 | mBC | Positive |
NCT02924883 [140] | KATE2 | T-DM1 | Atezolizumab | IO | II | 2016 | mBC | Negative | |
NCT03364348 (completed) | Â NA | T-DM1 | Utomilumab | 4-1BB | IB | 2017 | mBC | NA | |
NCT03032107 [141] | Â NA | T-DM1 | Pembrolizumab | IO | Ib | 2017 | mBC | NA | |
NCT03523572 [77] | DS8201-A-U105 | T-DXd | Nivolumab | IO | Ib | 2018 | mBC & mUC | Positive | |
NCT04042701 [78] | Â NA | T-DXd | Pembrolizumab | IO | Ib | 2019 | mBC & mNSCLC | NA | |
NCT04379596 [142] | DESTINY-Gastric03 | T-DXd | 5-FU | CT | Ib/II | 2020 | mGC | NA | |
Durvalumab | IO | ||||||||
Capecitabine | CT | ||||||||
CAPOX | CT | ||||||||
5-FU and Durvalumab | CT + IO | ||||||||
Capecitabine, and Durvalumab | CT + IO | ||||||||
5-FU or Capecitabine, and Cisplatin or Oxaliplatin | CT | ||||||||
Chemotherapy (FP) and Pembrolizumab | CT + IO | ||||||||
Chemotherapy and BSP (MEDI5752) | CT + IO | ||||||||
5-FU or Capecitabine, and Pembrolizumab | CT + IO | ||||||||
Pembrolizumab | IO | ||||||||
NCT04556773 (active, not recruiting) | DB-08 | T-DXd | Durvalumab | IO | Ib | 2020 | mBC | NA | |
Capecitabine | CT | ||||||||
Capivasertib | CT | ||||||||
Durvalumab + Paclitaxel | CT + IO | ||||||||
Anastrozole | ET | ||||||||
Fulvestrant | ET | ||||||||
NCT04538742 [81] | DB-07 | T-DXd | Durvalumab | IO | Ib/2 | 2020 | mBC | NA | |
Tucatinib | HER2 TKI | ||||||||
Pertuzumab | HER2 mAb | ||||||||
Paclitaxel | CT | ||||||||
Durvalumab + Paclitaxel | CT + IO | ||||||||
NCT05480384 (recruiting) | BrUOG 413 | T-DXd | Nivolumab | IO | II | 2022 | Adjuvant, esophagogastric adenocarcinoma | NA | |
NCT04264936 [80] | RC48-C014 | RC48 | Toripalimab | IO | Ib/II | 2020 | mUC | Positive | |
NCT04460456 [143] | Â NA | SBT6050 | Pembrolizumab | IO | I | 2020 | Advanced solid tumors | Positive | |
Cemiplimab | IO | NA | |||||||
NCT05113459 (not yet recruiting) | RC48-C018 | RC48 | Sintilimab and Capecitabine | CT + IO | II | 2021 | Neoadjuvant, GC | NA | |
NCT04879329 [144] | RC48G001 | RC48 | Pembrolizumab | IO | II | 2021 | mUC | NA | |
NCT05016973 (not yet recruiting) | Â NA | RC48 | Triplizumab | IO | II | 2021 | Neoadjuvant, MIBC | NA | |
NCT04873362 [145] | Astefania | T-DM1 | Atezolizumab | IO | III | 2021 | Adjuvant, BC | NA | |
NCT04740918 [146] | KATE3 | T-DM1 | Atezolizumab | IO | III | 2021 | mBC | NA | |
NCT05488353 (not yet recruiting) | Â NA | RC48 | Penpulimab Injection | IO | Â | 2022 | Neoadjuvant, bladder urothelial carcinoma | NA | |
NCT05495724 (recruiting) | Â NA | RC48 | Tislelizumab | IO | II | 2022 | High-Risk Non-Muscle Invasive Bladder Cancer | NA | |
NCT05493683 (recruiting) | Â NA | RC48 | Tislelizumab | IO | II | 2022 | mCRC | NA | |
NCT05333809 (not yet recruiting) | Â NA | RC48 | Pembrolizumab | IO | II | 2022 | mCRC | NA | |
NCT05313906 (not yet recruiting) |  NA | RC48 | AK105 + Cisplatin | CT + IO | II | 2022 | mGC | NA | |
NCT05417230 (not yet recruiting) | Â NA | RC48 | Envafolimab | IO | II | 2022 | mBTC | NA | |
NCT05115500 (not yet recruiting) | PRaG3.0 | RC48 | Hypofractionated RT, PD-1/PD-L1 inhibitor sequential GM-CSF and IL-2 | IO + RT | II | 2022 | Advanced solid tumors | NA | |
NCT05297552 (recruiting) | Â NA | RC48 | Toripalimab | IO | II | 2022 | NA | ||
NCT05302284 (recruiting) | Â NA | RC48 | Toripalimab | IO | III | 2022 | mUC | NA | |
NCT05320588 (recruiting) | Â NA | BIO-106 | Pembrolizumab | IO | I/II | 2022 | Advanced solid tumors | NA | |
NCT05514158 (recruiting) |  NA | RC48 | Chemotherapy (Capecitabine or 5-FU) + Nivolumab | CT + IO | I | 2022 | mGC | NA | |
RC98 | IO | ||||||||
NCT05979740 (recruiting) |  NA | RC48 | Toripalimab + RT | IO + RT | II | 2023 | MIBC | NA | |
TROP2 | NCT03742102 [147] | BEGONIA | T-DXd | Durvalumab | IO | IB/II | 2018 | mBC | Positive |
Dato-DXd | Durvalumab | IO | NA | ||||||
NCT03337698 [148] | Morpheus Lung | SG | Atezolizumab | IO | Ib/II | 2017 | mNSCLC | Â | |
NCT03424005 (active, not recruiting) | Morpheus-panBC | SG | Atezolizumab | IO | Ib/II | 2018 | mBC | NA | |
NCT03971409 (recruiting) | InCITe | SG | Avelumab | IO | II | 2019 | mBC | NA | |
NCT03869190 [149] | MORPHEUS-UC | SG | Atezolizumab | IO | Ib/II | 2019 | mUC | NA | |
NCT04434040 [150] | ASPRIA | SG | Atezolizumab | IO | II | 2020 | Adjuvant, BC | NA | |
NCT04468061 [151] | Â NA | SG | Pembrolizumab | IO | II | 2020 | mBC | NA | |
NCT04448886 [152] | Â NA | SG | Pembrolizumab | IO | II | 2020 | mBC | NA | |
NCT04381832 [153] |  NA | SG | Etrumadenant + Zimberelimab | Dual adenosine receptor antagonist + IO | I/II | 2020 | mCRPC | Positive | |
NCT04863885 [154] | Â NA | SG | IPI-NIVO | IO | I/II | 2021 | mUC | Positive | |
NCT05382286 (recruiting) | ASCENT-04 | SG | Pembrolizumab | IO | III | 2022 | mBC | NA | |
NCT05186974 [155] | EVOKE-02 | SG | Pembrolizumab | IO | II | 2022 | mNSCLC | NA | |
Pembrolizumab and a platinum agent (Carboplatin or Cisplatin) | CT + IO | ||||||||
NCT05327530 [156] | JAVELIN Bladder Medley | SG | Avelumab | IO | II | 2022 | mUC | NA | |
NCT05687266 (recruiting) | AVANZAR | Dato-DXd | Durvalumab + Carboplatin | CT + IO | III | 2022 | mNSCLC | NA | |
NCT05489211 [157] | TROPION-PanTumor03 | Dato-Dxd | Durvalumab | IO | II | 2022 | Advanced solid tumors | NA | |
Durvalumab + AZD5305 | IO + PARP1 inhibitor | ||||||||
NCT04526691 [158] | TROPION-Lung02 | Dato-Dxd | Pembrolizumab | Carboplatin/ Cisplatin | I | 2020 | Advanced or metastatic NSCLC | Positive | |
NCT04612751 [159] | TROPION-Lung04 | Dato-Dxd | Durvalumab AZD2936 MEDI5752 | Carboplatin | Ib | 2020 | Advanced or metastatic NSCLC | NA | |
NCT05941507 (not yet recruiting) | Â NA | LCB84 | Anti-PD-1 | IO | I/II | 2023 | Advanced solid tumors | NA | |
Nectin-4 | NCT03924895 [160] | KEYNOTE-905/EV-303 | EV | Pembrolizumab | IO | III | 2019 | Perioperative, MIBC | NA |
NCT04223856 [161] | EV-302 | EV | Pembrolizumab | IO | III | 2020 | mUC | Positive | |
Pembrolizumab + Cisplatin or Carboplatin | CT + IO | NA | |||||||
NCT04960709 [162] | VOLGA | EV | Durvalumab + Tremelimumab | IO | III | 2021 | Perioperative, MIBC | NA | |
Durvalumab | IO | ||||||||
NCT04700124 [163] | MK-3475-B15/ KEYNOTE-B15 / EV-304 | EV | Pembrolizumab | IO | III | 2021 | Perioperative, MIBC | NA | |
NCT05239624 (recruiting) | EV-ECLIPSE | EV | Pembrolizumab | IO | II | 2022 | Neoadjuvant, UC | NA | |
NCT05756569 (not yet recruiting) | Â NA | EV | Pembrolizumab | IO | II | 2023 | mUC | NA | |
NCT05775471 (not yet recruiting) | Â NA | EV | Pembrolizumab | IO | II | 2023 | Perioperative, High-risk upper tract urothelial cancer | NA | |
EGFR | NCT04305795 (active, not recruiting) | Â NA | ASP-1929 | Pembrolizumab | IO | I/II | 2020 | Advanced solid tumors | NA |
Cemiplimab | IO | ||||||||
EGFR | NCT05265013 (active, not recruiting) | Â NA | ASP-1929 | Pembrolizumab | IO | II | 2022 | Locoregional recurrent SCCHNC, with or without metastases, not amenable to curative local treatment | NA |
ROR2 | NCT03504488 (recruiting) | Â NA | CAB-ROR2-ADC | PD-1 inhibitor | IO | I/II | 2018 | Advanced solid tumors | NA |
FRα | NCT02606305 [28] |  NA | Elahere | Pembrolizumab | IO | Ib/II | 2022 | High-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers | NA |
NCT03835819 [164] | Â NA | Elahere | Pembrolizumab | IO | II | 2019 | mEC | NA | |
AXL | NCT03425279 [165] | Â NA | CAB-AXL-ADC | PD-1 inhibitor | IO | I/II | 2018 | Advanced, refractory sarcoma | NA |
AXL | NCT04681131 (recruiting) | Â NA | CAB-AXL-ADC | PD-1 inhibitor | IO | II | 2021 | mNSCLC | NA |