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.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Autogene cevumeran	Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
DRUG	Pembrolizumab	Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.

Timeline

• Start date: 2018-12-21
• Primary completion: 2025-01-21
• Completion: 2025-01-21
• First posted: 2019-01-24
• Last updated: 2026-01-30
• Results posted: 2026-01-30

Locations

41 sites across 6 countries: United States, Australia, Belgium, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study