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 2
Completed
NCT03815058
| Condition | Advanced Melanoma |
|---|
| Phase | Phase 2 |
|---|
| Sponsor | Genentech, Inc. |
|---|
| Status | Completed |
|---|
| Enrollment | 131 participants |
|---|
| Interventions | Autogene cevumeran, Pembrolizumab |
|---|
| Start date | Dec 21, 2018 |
|---|
| Completion date | Jan 21, 2025 |
|---|
| Results posted | Jan 30, 2026 |
|---|
Summary
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.
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization
From randomization to PD or death (up to approximately 60 months) · months
| Arm A: Pembrolizumab | 7.9 months |
|---|
| Arm B: Pembrolizumab + RO7198457 | 8.3 months |
|---|
| p-value | 0.3284 |
|---|
| Hazard Ratio (HR) | 0.79 (95% CI 0.49–1.27) |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.