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.

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.

Timeline

Start

2018-12-21

Primary completion

2025-01-21

Completion

2025-01-21

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm A: Pembrolizumab vs Arm B: Pembrolizumab + RO7198457; p = 0.3284 NCT03815058 ↗

release “previously untreated advanced melanoma were presented at the 2025 ESMO Congress. While, as previously disclosed, the trial did not meet its primary efficacy endpoint” biontech.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Autogene cevumeran	Messenger RNA (mRNA)	—	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications