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.
- Conditions
- Advanced Melanoma
- Interventions
- Registration Number
- NCT03815058
- Lead Sponsor
- Genentech, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
- 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.
Exclusion criteria:
- Ocular/uveal melanoma;
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Safety Run-in Period: Autogene Cevumeran + Pembrolizumab Autogene cevumeran 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. Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab Autogene cevumeran 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. Safety Run-in Period: Autogene Cevumeran + Pembrolizumab 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. Randomized Period: Arm A: Pembrolizumab 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. Randomized Period: Arm B: Autogene Cevumeran + Pembrolizumab 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.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization The time from randomization to disease progression/death (up to approximately 24 months)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization Up to approximately 24 months Overall Survival (OS) After Randomization The time from randomization to death from any cause (up to approximately 24 months). Duration of Response (DOR) According to RECISTv.1.1 After Randomization The time from randomization up to approximately 24 months. Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization From randomization up to approximately 24 months. The 2-item GHS/HRQoL questionnaire of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30) uses a 7-point scale from 1=very poor to 7= excellent. Score range for GHS/HRQoL is 2-14. A negative change from baseline indicates deterioration in GHS.
Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over Up to 12 months from the time of cross-over Percentage of Participants With Adverse Events (AEs) Baseline up to 90 days after the final dose of study drug (up to approximately 27 months)
Trial Locations
- Locations (41)
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Atlanta Cancer Care
🇺🇸Alpharetta, Georgia, United States
Case Western Research University
🇺🇸Cleveland, Ohio, United States
Elbe Kliniken Stade-Buxtehude GmbH
🇩🇪Buxtehude, Germany
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
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
Northwestern University
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital.
🇺🇸Boston, Massachusetts, United States
Washington University
🇺🇸Saint Louis, Missouri, 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
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
Sint Augustinus Wilrijk
🇧🇪Wilrijk, Belgium
Universitatsklinikum Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Universitätsklinikum Koeln
🇩🇪Koeln, 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
🇩🇪Muenster, Germany
Universitätshautk. Tübingen
🇩🇪Tübingen, Germany
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
🇪🇸Sevilla, Spain
Barts and The London
🇬🇧London, United Kingdom