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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
40
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.
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.
Institut Jules Bordet
Brussels, Belgium
UZ Brussel
Brussels, Belgium
CHIREC Edith Cavell
Brussels, Belgium
UZ Antwerpen
Edegem, Belgium
UZ Gent
Ghent, 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
...and 4 more locations
Number of Participants with BRAF V600 Mutation as Assessed Using the Idylla^TM Diagnostic Platform
Time frame: Days -56 to -1 (Pre-screening period)
Concentration of BRAF V600 Mutation as Determined on Plasma cfDNA
Time frame: Days -56 to -1 (Pre-screening period)
Number of Participants by BRAF Mutation Status
Time frame: Days -56 to -1 (Pre-screening period)
Number of Participants with BRAF V600 Mutation as Assessed Using the Idylla^TM Diagnostic Platform in Participants With BRAF Wild-Type Based on a Prior Tissue Test Result
Time frame: Days -56 to -1 (Pre-screening period)
Percentage of Participants with Objective Response as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Baseline up to disease progression or death whichever occurs first (up to 38 months)
Progression-Free Survival (PFS)
Time frame: Baseline up to disease progression or death whichever occurs first (up to 38 months)
Duration of Response as Assessed by Investigator According to RECIST v1.1
Time frame: Baseline up to disease progression or death whichever occurs first (Up to 38 months)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 Cycle 1 up to 4 weeks after end of treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to 38 months)
Overall Survival
Time frame: Baseline up to death (up to 38 months)
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