Phase 2
Completed N=6
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.
Advanced Melanoma
Source: ClinicalTrials.gov NCT03815058 ↗
Enrolled (actual)
6
Serious AEs
34.3%
Results posted
Jan 2026
Primary outcomePrimary: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization — 7.9; 8.3 months — p=0.3284
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization |
7.9; 8.3 | 0.3284 |
| SECONDARY Objective Response Rate (ORR) According to RECIST V.1.1 After Randomization |
48.8; 41.7 | — |
| SECONDARY Overall Survival (OS) After Randomization |
NA; 62.2 | — |
| SECONDARY Duration of Response (DOR) According to RECIST V.1.1 After Randomization |
NA; NA | — |
| SECONDARY Change From Baseline in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score Assessed by European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire (EORTC QLQ-C30) |
64.74; 73.39; 0.00; -1.85; -1.37; 2.60 | — |
| SECONDARY ORR According to RECIST V.1.1 After Crossover |
40.0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
6; 43; 79; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Life expectancy >/= 12 weeks;
- Adequate hematologic and end-organ function;
- Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions;
- Tumor specimen availability;
- Measurable disease per RECIST v1.1.
Exclusion criteria
- Ocular/uveal melanoma;
- Any anti-cancer therapy with the exceptions as specified in the protocol;
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
- Previous splenectomy;
- History of autoimmune disease;
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation;
- Positive test for Human Immunodeficiency Virus (HIV) infection;
- Active hepatitis B or C or tuberculosis;
- Significant cardiovascular disease;
- Known clinically significant liver disease.
Data sourced from ClinicalTrials.gov (NCT03815058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.