At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 131 enrolled
Drug / intervention
Autogene cevumeran +1 morebiological
Likely dose
Pembrolizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced Melanoma
In Brief
A Phase 2 clinical trial evaluating Autogene cevumeran and Pembrolizumab for Advanced Melanoma. Completed, enrolled 131 participants across 41 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Melanoma
CountriesAustralia, Belgium, Germany, Spain, United Kingdom, United States
CollaboratorsBioNTech SE
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
Enrollment StartDec 2018
First PostedJan 2019
Primary CompletionJan 2025
TodayJul 2026
First PostedJan 24, 2019
Enrollment StartDec 21, 2018
Primary CompletionJan 21, 2025
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 7.4 years ago
Interventions
Autogene cevumeranbiological
Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
Pembrolizumabdrug
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.