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.

PHASE2CompletedINTERVENTIONAL
Enrollment

131

Participants

Timeline

Start Date

January 8, 2019

Primary Completion Date

January 21, 2025

Study Completion Date

January 21, 2025

Conditions
Advanced Melanoma
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.

Trial Locations (41)

2170

Liverpool Hospital, Liverpool

2610

Sint Augustinus Wilrijk, Wilrijk

2650

Antwerp University Hospital, Edegem

3000

Peter MacCallum Cancer Centre, Melbourne

3181

Alfred Hospital, Melbourne

5011

The Queen Elizabeth Hospital, Woodville South

6008

St. John of God - Subiaco Hospital, Subiaco

20246

Universitatsklinikum Eppendorf, Hamburg

21614

Elbe Kliniken Stade-Buxtehude GmbH, Buxtehude

22906

University of Virginia, Charlottesville

23562

Uni Schleswig-Holstein, Lübeck

28007

Hospital General Universitario Gregorio Marañon, Madrid

30005

Atlanta Cancer Care, Alpharetta

31008

Clinica Universidad de Navarra, Pamplona

32256

Cancer Specialists, Jacksonville

33612

Moffitt McKinley Outpatient Center, Tampa

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

41009

Hospital Universitario Virgen Macarena, Seville

48157

Fachklinik Hornheide, Münster

50937

Universitätsklinikum Koeln, Cologne

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik, Mainz

60611

Northwestern University, Chicago

63110

Washington University, St Louis

68167

Med. Fakultat Mannheim der Universitat Heidelberg, Mannheim

69120

Universitätsklinikum Heidelberg, Heidelberg

72076

Universitätshautk. Tübingen, Tübingen

80262

University of Colorado, Denver

84107

Intermountain Surgical Oncology, Murray

84112

Huntsman Cancer Institute, Salt Lake City

91010

City of Hope Comprehensive Cancer Center, Duarte

92037

University of California San Diego Moores Cancer Center, La Jolla

94115

UCSF Comprehensive Cancer Ctr, San Francisco

97239

Oregon Health and Science University, Portland

98109

Seattle Cancer Care Alliance, Seattle

280146

Hospital Universitario La Paz, Madrid

02114

Massachusetts General Hospital., Boston

44106-5067

Case Western Research University, Cleveland

08028

Instituto Oncológico Dr. Rosell, Barcelona

08035

Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

EC1M 6BQ

Barts and The London, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

BioNTech SE

INDUSTRY

lead

Genentech, Inc.

INDUSTRY

NCT03815058 - 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. | Biotech Hunter | Biotech Hunter