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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.

NCT03815058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2026-01-30

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • BioNTech SE

    collaborator INDUSTRY

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2025-01-21
Completion
2025-01-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03815058 on ClinicalTrials.gov