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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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pre-screening phase:
Participants with histologically confirmed cutaneous melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer 7th edition
Documentation of BRAF V600 test result mutation-positive status on melanoma tumor tissue using a validated tissue test
Treatment Phase:
Eastern Cooperative Oncology Group performance status of 0-2
Adequate hematologic and end organ function obtained within 14 days prior to first dose of study drug treatment
Negative serum pregnancy test prior to commencement of dosing in women of childbearing potential
Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and treatment regimen and follow-up after treatment discontinuation schedule
Female participants of childbearing potential and male participants with partners of childbearing potential must agree to always use two effective forms of contraception during the course of this study and for at least 6 months after completion of study therapy
Participants should be able to swallow tablets
Documentation of BRAF mutation positive status in melanoma tissue
You may not be if
Treatment Phase:
History of prior rapidly accelerated fibrosarcoma or mitogen-activated protein kinase pathway inhibitor treatment
Use of prior chemotherapy or immunotherapy (including treatment with an anti-programmed death 1, or anti- programmed death ligand 1 or anti-cytotoxic T-lymphocyte-associated protein 4 monoclonal antibody) within 4 weeks before first study drug administration
Palliative radiotherapy within 14 days prior to the first dose of study treatment
Evidence of retinal pathology on ophthalmologic examination
Systemic risk factors for retinal vein occlusion
History of clinically significant cardiac dysfunction
Current severe, uncontrolled systemic disease
Pregnancy, lactating or breast feeding
Intake of St. John's wort or hyperforin (a potent cytochrome P450 3A4 \[CYP3A4 enzyme inducer\] and grapefruit juice (a potent CYP3A4 enzyme inhibitor) at least 7 days prior to initiation of and during the study treatment
Clareo Health | 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
