Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.
Official Title: A Phase Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy
Study ID: NCT04835805
Conditions
Study Description
Brief Summary: This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.
Detailed Description: The study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (Belva arm); a belvarafenib plus cobimetinib arm (Belva + Cobi arm) in an initial dose-finding phase followed by an expansion phase and a belvarafenib plus cobimetinib plus nivolumab arm (Belva + Cobi + Nivo arm) in a run-in phase followed by an expansion phase.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chao Family Comprehensive Cancer Center UCI, Orange, California, United States
California Pacific Medical Center Research Institute, San Francisco, California, United States
UCSF Helen Diller Family CCC, San Francisco, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
University of Iowa, Iowa City, Iowa, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan Kettering, New York, New York, United States
Sarah Cannon Research Institute /Tennessee Oncology, Nashville, Tennessee, United States
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Peter MacCallum Cancer Centre-East Melbourne, Melbourne, Victoria, Australia
Linear Clinical Research Ltd, Nedlands, Western Australia, Australia
Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Princess Margaret Hospital; Department of Med Oncology, Toronto, Ontario, Canada
The Sir Mortimer B. Davis General Hospital, Montreal, Quebec, Canada
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Klinikum Mannheim GmbH Universitätsklinikum, Mannheim, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
Asan Medical Center - PPDS, Seoul, , Korea, Republic of
Samsung Medical Center - PPDS, Seoul, , Korea, Republic of
Haukeland Universitetssykehus, Bergen, , Norway
Oslo universitetssykehus HF, Oslo, , Norway
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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