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
Sites (40)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| St. John of God Subiaco Hospital Coordinator of this site? Confirm its status | Subiaco | Australia | Unknown status |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville South | Australia | Unknown status |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| ZAS Sint Augustinus Wilrijk Coordinator of this site? Confirm its status | Wilrijk | Belgium | Unknown status |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Completed |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Completed |
| Universitat Heidelberg Coordinator of this site? Confirm its status | Mannheim | Germany | Completed |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Completed |
| Instituto Oncologico Dr. Rosell S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Barts and The London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Atlanta Cancer Care Coordinator of this site? Confirm its status | Alpharetta | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Case Western Research University Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Cancer Specialists Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| University of California San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Intermountain Surgical Oncology Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| Sarah Cannon Research Institute (Tennessee Oncology) Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| UCSF Comprehensive Cancer Ctr Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Moffitt McKinley Outpatient Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.