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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 57 Locations for this study
Scottsdale Arizona, 85258, United States
Duarte California, 91010, United States
La Jolla California, 92037, United States
Los Angeles California, 90025, United States
San Francisco California, 94158, United States
Denver Colorado, 80262, United States
Farmington Connecticut, 06030, United States
Washington District of Columbia, 20007, United States
Jacksonville Florida, 32256, United States
Tampa Florida, 33612, United States
Alpharetta Georgia, 30005, United States
Chicago Illinois, 60611, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63110, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97239, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Murray Utah, 84107, United States
Saint George Utah, 84780, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22906, United States
Seattle Washington, 98109, United States
Sydney New South Wales, 2080, Australia
Woodville South South Australia, 5011, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3181, Australia
Subiaco Western Australia, 6008, Australia
Bruxelles , 1200, Belgium
Edegem , 2650, Belgium
Kortrijk , 8500, Belgium
Liège , 4000, Belgium
Wilrijk , 2610, Belgium
Buxtehude , 21614, Germany
Erlangen , 91054, Germany
Hamburg , 20246, Germany
Hannover , 30625, Germany
Heidelberg , 69120, Germany
Koeln , 50937, Germany
Lübeck , 23562, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
Muenster , 48157, Germany
Tübingen , 72076, Germany
Pamplona Navarra, 31008, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28007, Spain
Madrid , 28014, Spain
Madrid , 28027, Spain
Madrid , 28041, Spain
Sevilla , 41009, Spain
Valencia , 46009, Spain
London , EC1M , United Kingdom
London , SW3 6, United Kingdom
How clear is this clinincal trial information?