4 trials tracked · 2 active · last refreshed 2026-08-10
Autogene cevumeran (BNT122, developed with Genentech) is BioNTech's individualized neoantigen mRNA vaccine — synthesized fresh for each patient from their own tumor's mutations, rather than off-the-shelf. It first drew attention testing against pancreatic cancer, where an early trial linked vaccine-induced T-cell responses to no recurrence at 3 years in about half of treated patients — the most striking single readout of any cancer vaccine so far, though still from a small Phase I trial.
Its two active trials have both moved to Phase II, adding it on top of standard checkpoint-inhibitor/chemotherapy combinations (nivolumab, atezolizumab) rather than testing it alone, and the tracked condition list has broadened well beyond pancreatic cancer to include melanoma, bladder, colorectal, and several other solid tumors — reflecting how early and exploratory this program still is despite the attention its pancreatic result got.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | NCT06534983 | A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran With Nivolumab Versus Nivolumab Alone in Participants With High-risk Muscle-invasive Urothelial Carcinoma (MIUC) | Phase II | Active, not recruiting | 2024-12-09 |
The original purpose of this study was to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomized in either autogene cevumeran + nivolumab or the nivolumab monotherapy arm. Following the Sponsor's decision to phase out the study, as of Protocol Version 5, the primary purpose of the study is to ensure treatment continuity and safety for the participants who continue to participate in the study and receive study treatment. Enrollment 62 (estimated) Sites 43 across 15 countries Countries Argentina, Australia, Canada, Denmark, Germany +10 more Sponsor Hoffmann-La Roche Primary outcome: Number of Participants With Adverse Events (AEs) | |||||
| ▸ | NCT05968326 | A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC | Phase II | Recruiting | 2023-10-18 |
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery. Enrollment 260 (estimated) Sites 89 across 10 countries Countries Belgium, Canada, France, Germany, Netherlands +5 more Sponsor Genentech, Inc. Primary outcome: Disease Free Survival (DFS) | |||||
| ▸ | NCT03815058 | A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma. | Phase II | Completed | 2018-12-21 |
This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of autogene cevumeran (RO7198457) plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma. Enrollment 131 (actual) Sites 41 across 6 countries Countries Australia, Belgium, Germany, Spain, United Kingdom +1 more Sponsor Genentech, Inc. Primary outcome: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization | |||||
| ▸ | NCT03289962 | A Study of Autogene Cevumeran (RO7198457) as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Tumors | Phase I | Completed | 2017-12-21 |
This is a Phase 1a/1b, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, immune response, and pharmacokinetics of autogene cevumeran (RO7198457) as a single agent and in combination with atezolizumab (MPDL3280A, an engineered anti-programmed death-ligand 1 \[anti-PD-L1\] antibody). Enrollment 273 (actual) Sites 33 across 8 countries Countries Belgium, Canada, Germany, Netherlands, Spain +3 more Sponsor Genentech, Inc. Primary outcome: Percentage of Participants with Dose-Limiting Toxicities (DLTs) | |||||
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