Clinical trial 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Melanoma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: BioNTech SE
First posted: 2019-01-24
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECISTv.1.1) After Randomization
timeFrame: The time from randomization to disease progression/death (up to approximately 24 months)
Secondary outcomes:
measure: Objective Response Rate (ORR) According to RECISTv.1.1 After Randomization
timeFrame: Up to approximately 24 months
measure: Overall Survival (OS) After Randomization
timeFrame: The time from randomization to death from any cause (up to approximately 24 months).
measure: Duration of Response (DOR) According to RECISTv.1.1 After Randomization
timeFrame: The time from randomization up to approximately 24 months.
measure: Mean Change in Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score After Randomization
timeFrame: From randomization up to approximately 24 months.
measure: Objective Response Rate (ORR) According to RECISTv.1.1 After Cross Over
timeFrame: Up to 12 months from the time of cross-over
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to 90 days after the final dose of study drug (up to approximately 27 months)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Ctr
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Jacksonville
country: United States
facility: Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Moffitt McKinley Outpatient Center
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Cancer Care
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital.
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Cleveland
country: United States
facility: Case Western Research University
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Nashville
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Murray
country: United States
facility: Intermountain Surgical Oncology
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Subiaco
country: Australia
facility: St. John of God - Subiaco Hospital
state: Western Australia
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Buxtehude
country: Germany
facility: Elbe Kliniken Stade-Buxtehude GmbH
city: Hamburg
country: Germany
facility: Universitatsklinikum Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Koeln
country: Germany
facility: Universitätsklinikum Koeln
city: Lübeck
country: Germany
facility: Uni Schleswig-Holstein
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
city: Mannheim
country: Germany
facility: Med. Fakultat Mannheim der Universitat Heidelberg
city: Muenster
country: Germany
facility: Fachklinik Hornheide
city: Tübingen
country: Germany
facility: Universitätshautk. Tübingen
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Instituto Oncológico Dr. Rosell
city: Barcelona
country: Spain
facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: London
country: United Kingdom
facility: Barts and The London
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: