Melanoma Clinical Trial

A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.

Summary

This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

View Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

131

Study ID:

NCT03815058

Recruitment Status:

Active, not recruiting

Sponsor:

Genentech, Inc.

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There are 57 Locations for this study

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HonorHealth Research Institute - Bisgrove
Scottsdale Arizona, 85258, United States
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
The Los Angeles Clinic
Los Angeles California, 90025, United States
UCSF Comprehensive Cancer Ctr
San Francisco California, 94158, United States
University of Colorado
Denver Colorado, 80262, United States
University of Connecticut Health Center
Farmington Connecticut, 06030, United States
Georgetown University
Washington District of Columbia, 20007, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville Florida, 32256, United States
Moffitt McKinley Outpatient Center; McKinley Pharmacy
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
Dana Farber Can Ins
Boston Massachusetts, 02215, United States
Washington University; Wash Uni. Sch. Of Med
Saint Louis Missouri, 63110, United States
Case Western Research University; University Hospitals Case Medical Center
Cleveland Ohio, 44106, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Intermountain Surgical Oncology
Murray Utah, 84107, United States
Intermountain Heathcare/Dixie Regional
Saint George Utah, 84780, United States
Huntsman Cancer Institute; University of Utah
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; Haematology/Oncology
Woodville South South Australia, 5011, Australia
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne Victoria, 3000, Australia
Alfred Hospital; Medical Oncology
Melbourne Victoria, 3181, Australia
St. John of God - Subiaco Hospital
Subiaco Western Australia, 6008, Australia
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
Antwerp University Hospital
Edegem , 2650, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Sint Augustinus Wilrijk
Wilrijk , 2610, Belgium
Elbe Kliniken Stade-Buxtehude GmbH; Klinik für Dermatologie
Buxtehude , 21614, Germany
Universitaetsklinikum Erlangen
Erlangen , 91054, Germany
Universitatsklinikum Eppendorf; Klinik fur Dermatologie und Vernerologie
Hamburg , 20246, Germany
Medizinische Hochschule Hannover
Hannover , 30625, Germany
Universitätsklinikum Heidelberg; Hauttumorzentrum
Heidelberg , 69120, Germany
Universitätsklinikum Koeln
Koeln , 50937, Germany
Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)
Lübeck , 23562, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik
Mainz , 55131, Germany
Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie
Mannheim , 68167, Germany
Fachklinik Hornheide
Muenster , 48157, Germany
Universitätshautk. Tübingen
Tübingen , 72076, Germany
Clinica Universidad de Navarra
Pamplona Navarra, 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; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Universitario La Paz
Madrid , 28014, Spain
Clinica Universidad de Navarra-Madrid
Madrid , 28027, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Fundacion Instituto Valenciano de Oncologia (IVO)
Valencia , 46009, Spain
Barts and The London
London , EC1M , United Kingdom
The Royal Marsden NHS Foundation Trust; Oncology
London , SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

131

Study ID:

NCT03815058

Recruitment Status:

Active, not recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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