Table 1.
Ongoing clinical trials of dendritic cell-based vaccines for treatment of various types of tumors.
| Type of tumor | Type of TAA pulsed to DC | Vaccine composition | Primary / secondary outcomes | Sponsor | Phase | NCT identifier |
|---|---|---|---|---|---|---|
| Brain tumors | ||||||
| newly diagnosed glioblastoma | tumor lysate | DC-vaccine/ temozolomide* | Toxicity/ Clinical benefit rate, duration of response, overall response rate | Mayo Clinic, National Cancer Institute (NCI), USA | early phase 1 | NCT01957956, 2013 |
| recurrent glioblastoma | tumor lysate | DC-vaccine | Toxicity/ Clinical benefit rate, duration of response, overall response rate, OS, PFS, time to response | early phase 1 | NCT03360708, 2017 | |
| malignant glioma/glioblastoma, | tumor lysate | DC-vaccine/ Imiquimod** | Adverse events/ OS, PFS, IR | Macarena De La Fuente, University of Miami, USA | Phase 1 | NCT01808820, 2013 |
| glioma/ astrocytoma/ astrodendroglioma/ glioblastoma | tumor lysate | DC-vaccine + 0.2% resiquimod**/ autologous DC-vaccine + poly ICLC# | Most effective combination of DC vaccine components/ Time to tumor progression, OS | Jonsson Comprehensive Cancer Center, USA | Phase 2 | NCT01204684, 2010 |
| recurrent glioblastoma | tumor lysate | DC-vaccine/Nivolumab$ | Adverse events, OS/ PFS, QoL, CR, PR, SD, PD, RSDR | Phase 2 | NCT03014804, 2017 | |
| recurrent malignant glioma/ astrocytoma/ glioblastoma | CMV pp65-LAMP mRNA | DC-vaccine/Nivolumab$ | Safety/ OS, PFS | Gary Archer Ph.D., Duke University, USA | Phase 1 | NCT02529072, 2015 |
| glioblastoma | DCs/ autologous lymphocytes/ tetanus toxoid | Feasibility, safety/ humoral and cellular IR, time to progression | Phase 1 | NCT00639639, 2008 | ||
| Melanoma | ||||||
| malignant melanoma | tumor lysate | DC-vaccine/ T-cells/ cyclophosphamide*/ fludorabine* | Safety/ Time to disease progression | Karolinska University Hospital, Sweden | Phase 1 | NCT01946373, 2013 |
| metastatic melanoma | tumor lysate | TLPLDC-vaccine@/ Checkpoint inhibitors | Safety/ Tumor response to treatment | Cancer Insight, LLC, USA | Phase 1/ Phase 2 | NCT02678741, 2016 |
| melanoma | TLPLDC-vaccine@ | Disease free survival | Phase 2 | NCT02301611, 2014 | ||
| malignant melanoma Stage III/ Stage IV |
tumor lysate | DC-vaccine/RT/IFN-α | Safety, tolerability, feasibility, irDCR, IR / OS, irTTP, irORR, irDOR, irTTR, irPFS | Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumouri, Italy | Phase 2 | NCT01973322, 2013 |
| DC-vaccine | RFS/ OS, IR | Phase 2 | NCT02718391, 2016 | |||
| advanced melanoma | tumor-derived peptide | DC-vaccine/ Pembrolizumab$/ cyclophosphamide* | IR/ Clinical response, time to progression, safety, adverse events | University of Pennsylvania, USA | Phase 1 | NCT03092453, 2017 |
| uveal melanoma | tumor-derived RNA | DC-vaccine | Prolongation of disease free survival/ OS, IR | University Hospital Erlangen, Germany | Phase 3 | NCT01983748, 2013 |
| Colorectal cancer | ||||||
| colorectal cancer | tumor-associated antigen CEA | DC vaccine | Safety, feasibility/ Antigen-specific IR, pathological responses, disease-free survival | Radboud University, Netherlands | Phase 1/ Phase 2 | NCT01885702, 2013 |
| metastatic colorectal cancer | tumor lysate | DC-vaccine/ FOLFOX6§ | PFS/ Objective response, OS, QoL, adverse events | Second Military Medical University, China | Phase 3 | NCT02503150, 2015 |
| colorectal cancer | tumor lysate | DC-vaccine/ Avelumab$ | Dosed of Avelumab and DCs, PFS/ Adverse events, immunophenotype of tumors, MSS, RAS and BRAF mutation status | Grupo Espanol Multidisciplinario del Cancer Digestivo, Spain | Phase 1/ Phase 2 | NCT03152565, 2017 |
| Ovarian cancer | ||||||
| ovarian cancer | tumor lysate | DC vaccine /ontak& | IR/ Toxicity | Loyola University, USA | Phase 2 | NCT00703105, 2008 |
| ovarian cancer primary peritoneal cancer fallopian tube cancer |
– | DC-tumor fusion vaccine/ GM-CSF, imiquimod** | IR/ Toxicity, clinical response | Beth Israel Deaconess Medical Center, Israel | Phase 2 | NCT00799110, 2008 |
| Lung cancer | ||||||
| Small-cell lung cancer | – | DC endogenously expressed p53 gene/ Ipilimumab, Nivolumab$ | DCR/ PFS, OS, ORR, IR | H. Lee Moffitt Cancer Center and Research Institute | Phase 2 | NCT03406715, 2018 |
| Non-small cell lung cancer© | peptides PRS pan-DR, MAGE-3 DP04, MAGE-1 A2, MAGE-3 A2, NY-ESO-1 A2 et MART-1 A2 | DC-derived exosomes | PFS | Gustave Roussy, Cancer Campus, Grand Paris, France | Phase 2 | NCT01159288, 2010 |
*chemotherapeutic; **immune response modifier; #poly ICLC, interstitial Cajal-like cells, TLR3 agonist; $monoclonal antibodies, immune checkpoint inhibitor; &anti CD25 denileukin diftitox; §FOLFOX6 - a specific chemotherapy regimen of Oxaliplatin, 5-Fluorouracil and Leucovorin; ©the study has been completed; @TLPLDC-vaccine - autologous tumor lysate, particle-loaded, dendritic cell vaccine;
OS, overall survival; PFS, progression free survival; QoL, quality of life; CR, number of participants with complete response; PR, number of participants with partial response; SD, number of participants with stable disease; PD, number of participants with progressive disease; RSDR, response/stable disease rate; RFS, relapse-free survival; irDCR, immune related disease control rate; irTTP, immuno-related time to progression; irORR, immuno-related overall response rate; irDOR, immuno-related duration of response; irTTR, immuno-related time to response; irPFS, immuno-related progression free survival; DCR, disease control rate; ORR, overall response rate; IR, immune response; RT, radiation treatment.