Table 1 List of all active, and completed or terminated phase II/III clinical trials of mRNA vaccines in cancer therapy
Sponsor | Vaccine type (delivery route) | Indication | ClinicalTrial.gov identifier (phase, allocation) | Combination | Opened | Status |
|---|---|---|---|---|---|---|
DC vaccine | ||||||
 Antwerp University Hospital | WT1 mRNA (i.d.) | Myeloid leukemia, multiple myeloma | NCT00965224 (II, randomized) | Standard-of-care | 2009 | Unknown [27] |
AML | NCT01686334 (II, randomized) | Conventional chemotherapy | 2012 | Recruiting | ||
GBM | NCT02649582 (I/II) | Temozolomide, temozolomide-based chemoradiation | 2015 | Recruiting | ||
Malignant pleural mesothelioma | NCT02649829 (I/II) | Conventional chemotherapy | 2017 | Recruiting | ||
 Argos Therapeutics | Total tumor mRNA and CD40L mRNA (i.d.) | RCC | NCT00678119 (II, single arm) | Standard-of-care (sunitinib) | 2008 | Completed [28] |
NCT01582672 (III, randomized) | 2012 | |||||
 Asterias Biotherapeutics, Inc. | hTERT mRNA with a LAMP-1 targeting sequence (i.d.) | AML (complete remission) | NCT00510133 (II, single arm) | None | 2007 | Completed [31] |
 Baylor College of Medicine | Tumor mRNA and tumor lysate (i.d.) | Pancreatic cancer | NCT04157127 (I) | Adjuvant to chemotherapy | 2020 | Recruiting |
 Duke University | LAMP-fused HCMV pp65 mRNA (i.d.) and td | Malignant neoplasms of brain | NCT00639639 (I) | None | 2006 | Active, not recruiting [32] |
NCT02366728 (II, randomized) | Temozolomide, basiliximab (antagonistic anti-CD25) | 2015 | Active, not recruiting [33] | |||
Glioblastoma | NCT03688178 (II, randomized) | Temozolomide, varlilumab (agonistic anti-CD27) | 2020 | Recruiting | ||
LAMP-fused HCMV pp65 mRNA, GM-CSF (i.d.) and td | Malignant neoplasms of brain | NCT03615404 (I) | None | 2018 | Active, not recruiting | |
Glioblastoma | NCT03927222 (II, single arm) | Temozolomide | 2019 | Recruiting | ||
 Guangdong 999 Brain Hospital | Tumor mRNA | Brain cancer, neoplasm metastasis | NCT02808416 (I) | None | 2016 | Active, not recruiting |
Recurrent glioblastoma | NCT02808364 (I) | None | 2016 | Active, not recruiting | ||
Glioblastoma TAA mRNA (i.d. and i.v.) | Glioblastoma | NCT02709616 (I) | Conventional chemo- and radiotherapy | 2016 | Active, not recruiting | |
 Hasumi International Research Foundation | IKKb-matured DCs with tumor mRNA, TAA mRNA (gp100, tyrosinase, PRAME, MAGE-A3, IDO) and neoAg mRNA (GNAQ/GNA11Q209 or R183) (i.v.) | Uveal metastatic melanoma | NCT04335890 (I) | None | 2020 | Recruiting |
 Herlev Hospital | PSA, PAP, survivin, hTERT mRNA (i.d.) | Metastatic prostate cancer | NCT01446731 (II, randomized) | Docetaxel | 2011 | Completed [34] |
 Immunomic Therapeutics, Inc. | HCMV pp65-shLAMP or pp65-flLAMP, GM-CSF and td (both) | GBM, glioblastoma, malignant glioma, astrocytoma | NCT02465268 (II, randomized) | Temozolomide | 2016 | Recruiting |
 Memorial Sloan Kettering Cancer Center | Langerhans-type DCs with Trp2 mRNA | Melanoma | NCT01456104 (I) | None | 2011 | Active, not recruiting |
Langerhans-type DCs with CT7, MAGE-A3, WT1 mRNA | Multiple myeloma | NCT01995708 (I) | Standard-of-care | 2014 | Active, not recruiting | |
 Oslo University Hospital | Tumor mRNA and hTERT, survivin TAA mRNA | Prostate cancer | NCT01197625 (I/II) | None | 2010 | Active, not recruiting |
 Radboud University | Tyrosinase, gp100 mRNA (i.d. and i.v.) | Melanoma | NCT02285413 (II, randomized) | Cisplatin | 2011 | Completed [35] |
 University Hospital Erlangen | Tumor mRNA | Uveal melanoma | NCT01983748 (III, randomized) | None | 2014 | Recruiting |
 University of Campinas | WT1 mRNA | Myelodysplastic syndromes, AML | NCT03083054 (I/II) | None | 2016 | Active, not recruiting |
 University of Florida | Total tumor mRNA and ex vivo expanded lymphocytes (i.v. and i.d.) | Medulloblastoma, neuroectodermal tumor | NCT01326104 (I, II) | None | 2010 | Active, not recruiting [36] |
Total tumor mRNA, ex vivo expanded lymphocytes, GM-CSF and td | Diffuse intrinsic pontine glioma, Brain stem glioma | NCT03396575 (I) | Cyclophosphamide + fludarabine lymphodepleting conditioning or temozolomide | 2018 | Recruiting | |
 Universitair Ziekenhuis Brussel, Bart Nens | MAGE-A3, MAGE-C2, tyrosinase and gp100 mRNA, co-electroporated with TriMix (CD70, CD40L, caTLR4) mRNA | Melanoma | NCT01302496 (II, single arm) | Ipilimumab (antagonistic anti-CTLA-4) | 2011 | |
Melanoma | NCT01676779 (II, randomized) | None | 2012 | Completed [39] | ||
Direct injection of mRNA | ||||||
 BioNTech SE | RNA-LPX with NY-ESO-1, MAGE-A3, tyrosinase and TPTE (i.v.) | Advanced melanoma | NCT02410733 (I) | None | 2015 | |
RNA-LPX with TNBC TAAs, p53 and neoAgs (warehouse) (i.v.) | TNBC | NCT02316457 (I) | None | 2016 | Active, not recruiting | |
RNA-LPX with ovarian TAAs (i.v.) | Ovarian cancer | NCT04163094 (I) | Carboplatin and paclitaxel | 2019 | Recruiting | |
RNA-LPX with prostate TAAs (i.v.) | Prostate cancer | NCT04382898 (I/II) | Cemiplimab (antagonistic anti-PD-1) and/or goserelin acetate | 2019 | Recruiting | |
RNA-LPX with HPV16 antigens (i.v.) | HPV16+ and PD-L1+ HNSCC | NCT04534205 (II, randomized) | Pembrolizumab (antagonistic anti-PD-1) | 2020 | Not yet recruiting | |
RNA-LPX with NY-ESO-1, MAGE-A3, tyrosinase and TPTE (i.v.) | Melanoma | NCT04526899 (II, randomized) | Cemiplimab | 2020 | Not yet recruiting | |
RNA-LPX with CLDN6 (i.v.) | Solid tumors | NCT04503278 (I/II) | CLDN6-specific CAR-T cells | 2020 | Recruiting | |
 Genentech Inc., BioNTech SE | RNA-LPX with tumor neoAgs (i.v.) | Different solid cancers | NCT03289962 (I) | Atezolizumab (antagonistic anti-PD-L1) | 2017 | Recruiting |
Melanoma | NCT03815058 (II, randomized) | Pembrolizumab | 2019 | Recruiting | ||
 Changhai Hospital; Stemirna Therapeutics | mRNA encoding neoAg (s.c.) | Esophageal squamous carcinoma, gastric-, pancreatic- and colorectal adenocarcinoma | NCT03468244 (NA) | None | 2018 | Recruiting |
 CureVac AG | Protamine-formulated mRNA (RNActive) PSA, PSMA, PSCA, STEAP1, PAP and MUC1 (i.d.) | Prostate cancer | NCT01817738 (I/II, randomized) | None | 2012 | |
NCT02140138 (II, randomized) | Radical prostatectomy | 2014 | Terminated (after enrollment of 35/36 patients) | |||
 eTheRNA | mRNA encoding tyrosinase, gp100, MAGE-A3, MAGE-C2, and PRAME and TriMix (CD40L, CD70 and caTLR4) mRNA (i.n.) | Melanoma | NCT03394937 (I) | None | 2018 | Recruiting [45] |
 Ludwig Institute for Cancer Research, CureVac AG, Böhringer Ingelheim | RNActive encoding NY-ESO-1, MAGE-C1, MAGE-C2, TPBG, survivin, MUC1 (i.d.) | Meatastatic NSCLC | NCT03164772 (I/II) | Durvalumab (antagonistic anti-PD-L1), Tremelimumab (antagonistic anti-CTLA-4) | 2017 | Recruiting |
 Merck Sharp & Dohme Corp. | LNP-formulated mRNA encoding different KRAS mutations (i.m.) | KRAS-mutant NSCLC, colorectal cancer, pancreatic adenocarcinoma | NCT03948763 (I) | Pembrolizumab | 2019 | Recruiting |
 ModernaTX Inc., Merck Sharp & Dohme Corp. | Lipid-formulated mRNA encoding neoAg (i.m.) | Solid tumors | NCT03313778 (I) | Pembrolizumab | 2017 | Recruiting [46] |
Melanoma | NCT03897881 (II, randomized) | Pembrolizumab | 2019 | Recruiting | ||
 University of Florida | Lipid-formulated mRNA with tumor and LAMP-fused HCMV pp65 TAA mRNA (i.v.) | Adult glioblastoma | NCT04573140 (I) | None | 2020 | Not yet recruiting |