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NCT03815058CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 30 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
131 (actual)
First submitted
7 Jan 2019
Start date
21 Dec 2018
Primary completion date
21 Jan 2025
Lead sponsor
Genentech, Inc.
Diseases
Melanoma
NCT number
NCT03815058
EU CT number
2023-507389-15-00
EudraCT number
2018-001773-24

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 131
  • From 21 Dec 2018 to the primary completion date, 21 Jan 2025
  • 40 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous splenectomy;
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation;

Other illness

  • Any anti-cancer therapy with the exceptions as specified in the protocol;
  • History of autoimmune disease;
  • Positive test for Human Immunodeficiency Virus (HIV) infection;
  • Active hepatitis B or C or tuberculosis;
  • Significant cardiovascular disease;
  • Known clinically significant liver disease.

Other

  • Ocular/uveal melanoma;
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liverpool Hospital
Coordinator of this site? Confirm its status
LiverpoolAustraliaUnknown status
Alfred Hospital
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MelbourneAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
St. John of God Subiaco Hospital
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SubiacoAustraliaUnknown status
The Queen Elizabeth Hospital
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Woodville SouthAustraliaUnknown status
Antwerp University Hospital
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EdegemBelgiumUnknown status
ZAS Sint Augustinus Wilrijk
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WilrijkBelgiumUnknown status
University Hospital Cologne AöR
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CologneGermanyCompleted
University Medical Center Hamburg-Eppendorf
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HamburgGermanyCompleted
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyCompleted
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyCompleted
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyCompleted
Universitat Heidelberg
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MannheimGermanyCompleted
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyCompleted
Instituto Oncologico Dr. Rosell S.L.
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BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Clinica Universidad de Navarra
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Barts and The London
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LondonUnited KingdomUnknown status
Atlanta Cancer Care
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AlpharettaUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
Case Western Research University
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ClevelandUnited StatesUnknown status
University of Colorado
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DenverUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Cancer Specialists
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JacksonvilleUnited StatesUnknown status
University of California San Diego Moores Cancer Center
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La JollaUnited StatesUnknown status
Intermountain Surgical Oncology
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MurrayUnited StatesUnknown status
Sarah Cannon Research Institute (Tennessee Oncology)
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NashvilleUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
Huntsman Cancer Institute
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Salt Lake CityUnited StatesUnknown status
UCSF Comprehensive Cancer Ctr
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San FranciscoUnited StatesUnknown status
Seattle Cancer Care Alliance
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SeattleUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Moffitt McKinley Outpatient Center
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.