Spots Global Cancer Trial Database for A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma
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Trial Identification
Brief Title: A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma
Official Title: A Single Arm, Open Label, Phase II, Multicenter Study to Assess The Detection of The BRAF V600 Mutation on cfDNA From Plasma in Patients With Advanced Melanoma
Study ID: NCT02768207
Conditions
Study Description
Brief Summary: This is a single arm, multicenter, open label, and non-randomized clinical study on adult participants with unresectable or metastatic melanoma. The study will be conducted in two phases. Pre-screening phase will assess the BRAF V600 mutation in a new mutation analysis triggered by a mutant plasma cfDNA test result. Treatment phase will assess the clinical outcome for the participants treated with vemurafenib plus cobimetinib. The length of the study will be approximately 38 months.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UZ Brussel, Brussel, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
CHIREC Edith Cavell, Bruxelles, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Gent, Gent, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
AZ Groeninge, Kortrijk, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
AZ Delta (Campus Wilgenstraat), Roeselare, , Belgium
AZ Nikolaas (Sint Niklaas), Sint Niklaas, , Belgium
Sint Augustinus Wilrijk, Wilrijk, , Belgium
Klinika Onkologii Klinicznej CO-I Kraków, Krakow, , Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu., Poznań, , Poland
Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie, Warszawa, , Poland
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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