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.
NCT ID: NCT03815058
Last Updated: 2026-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2018-12-21
2025-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Safety Run-in Period: Autogene Cevumeran + Pembrolizumab
Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by intravenous (IV) infusion followed by 200 mg pembrolizumab IV infusion every 3 weeks (Q3W) plus a recommended dose of autogene cevumeran.
Autogene cevumeran
Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Randomized Period: Arm A: Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W. Participants in Arm A have the option to cross over to combination treatment with autogene cevumeran plus pembrolizumab (Arm B) after confirmed disease progression.
Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab
Participants will receive at least one cycle of 200 mg pembrolizumab monotherapy by IV infusion followed by 200 mg pembrolizumab IV infusion Q3W plus a recommended dose of autogene cevumeran.
Autogene cevumeran
Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Interventions
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Autogene cevumeran
Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
Pembrolizumab
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Any anti-cancer therapy with the exceptions as specified in the protocol;
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases;
* Previous splenectomy;
* History of autoimmune disease;
* Prior allogeneic bone marrow transplantation or prior solid organ transplantation;
* Positive test for Human Immunodeficiency Virus (HIV) infection;
* Active hepatitis B or C or tuberculosis;
* Significant cardiovascular disease;
* Known clinically significant liver disease.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California San Diego Moores Cancer Center
La Jolla, California, United States
UCSF Comprehensive Cancer Ctr
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
Cancer Specialists
Jacksonville, Florida, United States
Moffitt McKinley Outpatient Center
Tampa, Florida, United States
Atlanta Cancer Care
Alpharetta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital.
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
Case Western Research University
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States
Intermountain Surgical Oncology
Murray, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
St. John of God - Subiaco Hospital
Subiaco, Western Australia, Australia
Antwerp University Hospital
Edegem, , Belgium
ZAS Sint Augustinus Wilrijk
Wilrijk, , Belgium
Elbe Kliniken Stade-Buxtehude GmbH
Buxtehude, , Germany
Universitätsklinikum Koeln
Cologne, , Germany
Universitatsklinikum Eppendorf
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Uni Schleswig-Holstein
Lübeck, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
Mainz, , Germany
Med. Fakultat Mannheim der Universitat Heidelberg
Mannheim, , Germany
Fachklinik Hornheide
Münster, , Germany
Universitätshautk. Tübingen
Tübingen, , Germany
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Instituto Oncológico Dr. Rosell
Barcelona, , Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Barts and The London
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-001773-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-507389-15-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
GO40558
Identifier Type: -
Identifier Source: org_study_id
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