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

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 23, 2016

Primary Completion Date

December 20, 2017

Study Completion Date

June 27, 2019

Conditions
Metastatic Melanoma
Interventions
DRUG

Cobimetinib

Participants will receive cobimetinib 60 mg tablets (three 20 mg tablet) orally OD for 21 consecutive days (Days 1 to 21), followed by a 7 day break (Days 22 to 28); in each 28-day cycle of treatment phase until disease progression, consent withdrawal, or the development of unacceptable toxicity.

DRUG

Vemurafenib

Participants will receive vemurafenib 960 mg tablets (four 240 mg tablet) orally BID from Day 1 to Day 28 of each 28-day cycle of the treatment phase until disease progression, consent withdrawal, or the development of unacceptable toxicity.

Trial Locations (14)

1000

Institut Jules Bordet, Brussels

1090

UZ Brussel, Brussels

1180

CHIREC Edith Cavell, Brussels

2610

Sint Augustinus Wilrijk, Wilrijk

2650

UZ Antwerpen, Edegem

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

5000

Clinique Ste-Elisabeth, Namur

8500

AZ Groeninge, Kortrijk

8800

AZ Delta (Campus Wilgenstraat), Roeselare

9000

UZ Gent, Ghent

9100

AZ Nikolaas (Sint Niklaas), Sint-Niklaas

Unknown

Klinika Onkologii Klinicznej CO-I Kraków, Krakow

60-780

Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu., Poznan

02-781

Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie, Warsaw

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02768207 - 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 | Biotech Hunter | Biotech Hunter