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.

Advanced Melanoma Clinical Trial

— IMCODE001  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03815058
• Other study ID #: GO40558
• Secondary ID: 2018-001773-24
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 8, 2019
• Est. completion date: October 30, 2025

Study information

• Verified date: April 2024
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Advanced Melanoma
• Melanoma

Intervention

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.

Locations

Country	Name	City	State
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Alfred Hospital; Medical Oncology	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre; Medical Oncology	Melbourne	Victoria
Australia	St. John of God - Subiaco Hospital	Subiaco	Western Australia
Australia	The Queen Elizabeth Hospital; Haematology/Oncology	Woodville South	South Australia
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	Antwerp University Hospital	Edegem
Belgium	AZ Groeninge	Kortrijk
Belgium	CHU Sart-Tilman	Liège
Belgium	Sint Augustinus Wilrijk	Wilrijk
Germany	Elbe Kliniken Stade-Buxtehude GmbH; Klinik für Dermatologie	Buxtehude
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Universitatsklinikum Eppendorf; Klinik fur Dermatologie und Vernerologie	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Heidelberg; Hauttumorzentrum	Heidelberg
Germany	Universitätsklinikum Koeln	Koeln
Germany	Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)	Lübeck
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik	Mainz
Germany	Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie	Mannheim
Germany	Fachklinik Hornheide	Muenster
Germany	Universitätshautk. Tübingen	Tübingen
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Instituto Oncológico Dr. Rosell	Barcelona
Spain	Vall d?Hebron Institute of Oncology (VHIO), Barcelona	Barcelona
Spain	Clinica Universidad de Navarra-Madrid	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Fundacion Instituto Valenciano de Oncologia (IVO)	Valencia
United Kingdom	Barts and The London	London
United Kingdom	The Royal Marsden NHS Foundation Trust; Oncology	London
United States	Atlanta Cancer Care	Alpharetta	Georgia
United States	Dana Farber Can Ins	Boston	Massachusetts
United States	Massachusetts General Hospital.	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Case Western Research University; University Hospitals Case Medical Center	Cleveland	Ohio
United States	University of Colorado	Denver	Colorado
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)	Jacksonville	Florida
United States	University of California San Diego Moores Cancer Center	La Jolla	California
United States	The Los Angeles Clinic	Los Angeles	California
United States	Intermountain Surgical Oncology	Murray	Utah
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Oregon Health and Science University	Portland	Oregon
United States	Intermountain Heathcare/Dixie Regional	Saint George	Utah
United States	Washington University; Wash Uni. Sch. Of Med	Saint Louis	Missouri
United States	Huntsman Cancer Institute; University of Utah	Salt Lake City	Utah
United States	UCSF Comprehensive Cancer Ctr	San Francisco	California
United States	HonorHealth Research Institute ? Bisgrove	Scottsdale	Arizona
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Moffitt McKinley Outpatient Center; McKinley Pharmacy	Tampa	Florida
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	BioNTech SE

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization		Up to approximately 24 months
Secondary	Overall Survival (OS) After Randomization		The time from randomization to death from any cause (up to approximately 24 months).
Secondary	Duration of Response (DOR) According to RECISTv.1.1 After Randomization		The time from randomization up to approximately 24 months.
Secondary	Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization	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.	From randomization up to approximately 24 months.
Secondary	Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over		Up to 12 months from the time of cross-over
Secondary	Percentage of Participants With Adverse Events (AEs)		Baseline up to 90 days after the final dose of study drug (up to approximately 27 months)