Table 2.
Clinical trials of mRNA encoding TSAs.
| Antigen | Brand | Title | Conditions | NCT Number | Phase | Study Start | Status | |
|---|---|---|---|---|---|---|---|---|
| Colorectal Cancer TSA | BNT122 | A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer | Colorectal Cancer Stage II/III | NCT04486378 | Phase 2 | March 8, 2021 | Recruiting | |
| Cancer TSAs | RO7198457 | A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors | Melanoma NSCLC Bladder Cancer | NCT03289962 | Phase 1 | December 21, 2017 | Active, not recruiting | |
| Cancer TSAs | RO7198457 | A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer | NSCLC | NCT04267237 | Phase 2 | March 31, 2021 | Withdrawn | |
| Cancer TSAs | RO7198457 | A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma | Advanced Melanoma | NCT03815058 | Phase 2 | January 8, 2019 | Active, not recruiting | |
| Cancer TSAs | mRNA-4157 | Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone in Participants With Resected Solid Tumors and in Combination With Pembrolizumab in Participants With Unresectable Solid Tumors | Solid Tumors | NCT03313778 | Phase 1 | August 14, 2017 | Recruiting | |
| Cancer TSAs | mRNA-4157 | An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942) | Melanoma | NCT03897881 | Phase 2 | July 18, 2019 | Active, not recruiting | |
| KRAS mutations: G12D,G12V G13D,G12C | mRNA-5671/V941 | A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) | NSCLC Pancreatic Neoplasms Colorectal Neoplasms | NCT03948763 | Phase 1 | June 26, 2019 | Active, not recruiting | |
| Cancer TSAs | SW1115C3 | A Study of Neoantigen mRNA Personalised Cancer in Patients With Advanced Solid Tumors | Solid Tumor | NCT05198752 | Phase 1 | March 12, 2022 | Not yet recruiting | |
| Cancer TSAs | IVAC MUTANOME | IVAC MUTANOME Phase I Clinical Trial | Melanoma | NCT02035956 | Phase 1 | December 2013 | Completed | |
| Cancer TSAs | NA | Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms | Esophageal Squamous Carcinoma Gastric/ Pancreatic/ Colorectal Adenocarcinoma | NCT03468244 | Not Applicable | May 1, 2018 | Unknown | |
| Cancer TSAs | NA | Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Gastric Cancer, Esophageal Cancer and Liver Cancer | Gastric/ Esophageal/ Liver Cancer | NCT05192460 | Not Applicable | February 2022 | Recruiting | |
| Cancer TSAs | NA | Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Gastric Cancer | Gastric Cancer | NCT05227378 | Not Applicable | March 2022 | Not yet recruiting | |
| Cancer TSAs | NA | Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Cancer and Non-small Cell Lung Cancer | Esophageal Cancer Non-Small Cell Lung Cancer | NCT03908671 | Not Applicable | May 2019 | Not yet recruiting | |
NA, Not Applicable.