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.
IMCODE001
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
3 other identifiers
interventional
131
6 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
Longer than P75 for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2018
CompletedFirst Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
January 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2025
CompletedResults Posted
Study results publicly available
January 30, 2026
CompletedJanuary 30, 2026
January 1, 2026
6.1 years
January 7, 2019
January 14, 2026
January 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization
PFS was defined as the time from randomization to the first documented PD as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Kaplan-Meier (KM) method was used to estimate median PFS.
From randomization to PD or death (up to approximately 60 months)
Secondary Outcomes (6)
Objective Response Rate (ORR) According to RECIST V.1.1 After Randomization
Up to approximately 60 months
Overall Survival (OS) After Randomization
From randomization to death (up to approximately 63 months)
Duration of Response (DOR) According to RECIST V.1.1 After Randomization
Up to approximately 60 months
Change From Baseline in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score Assessed by European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire (EORTC QLQ-C30)
Baseline, Day 1 of Cycles 1 to 34, time of first PD, time to last dose, treatment discontinuation and study drug completion (up to approximately 29 months) (1 cycle = 21 days)
ORR According to RECIST V.1.1 After Crossover
Up to 54.7 months
- +1 more secondary outcomes
Study Arms (3)
Safety Run-in Period: Autogene Cevumeran + Pembrolizumab
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Participants will receive a recommended dose of autogene cevumeran administered by IV infusion at protocol-defined intervals.
Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
- BioNTech SEcollaborator
Study Sites (41)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92037, United States
UCSF Comprehensive Cancer Ctr
San Francisco, California, 94115, United States
University of Colorado
Denver, Colorado, 80262, United States
Cancer Specialists
Jacksonville, Florida, 32256, United States
Moffitt McKinley Outpatient Center
Tampa, Florida, 33612, United States
Atlanta Cancer Care
Alpharetta, Georgia, 30005, United States
Northwestern University
Chicago, Illinois, 60611, United States
Massachusetts General Hospital.
Boston, Massachusetts, 02114, United States
Washington University
St Louis, Missouri, 63110, United States
Case Western Research University
Cleveland, Ohio, 44106-5067, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, 37203, United States
Intermountain Surgical Oncology
Murray, Utah, 84107, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22906, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Alfred Hospital
Melbourne, Victoria, 3181, Australia
St. John of God - Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Antwerp University Hospital
Edegem, 2650, Belgium
ZAS Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
Elbe Kliniken Stade-Buxtehude GmbH
Buxtehude, 21614, Germany
Universitätsklinikum Koeln
Cologne, 50937, Germany
Universitatsklinikum Eppendorf
Hamburg, 20246, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Uni Schleswig-Holstein
Lübeck, 23562, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
Mainz, 55131, Germany
Med. Fakultat Mannheim der Universitat Heidelberg
Mannheim, 68167, Germany
Fachklinik Hornheide
Münster, 48157, Germany
Universitätshautk. Tübingen
Tübingen, 72076, Germany
Clinica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Instituto Oncológico Dr. Rosell
Barcelona, 08028, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 280146, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Barts and The London
London, EC1M 6BQ, United Kingdom
MeSH Terms
Interventions
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 24, 2019
Study Start
December 21, 2018
Primary Completion
January 21, 2025
Study Completion
January 21, 2025
Last Updated
January 30, 2026
Results First Posted
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).