30
Participants
Start Date
June 1, 2022
Primary Completion Date
July 1, 2027
Study Completion Date
June 1, 2029
Nilotinib 100mg
Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 100mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
Nilotinib 200mg
Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 200mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
Nilotinib 300mg
Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 300mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
Nilotinib 400mg
Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) or encorafenib (450 mg PO) and binimetinib (45 mg PO BID) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 400mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
Dabrafenib
All patients will begin dabrafenib (150mg PO BID) on day one and will continue for 28 days.
Trametinib
All patients will begin trametinib (2mg PO once daily) on day one and will continue for 28 days.
Encorafenib
encorafenib will be administered orally 450mg once daily for 28 consecutive days
Binimetinib
binimetinib will be administered orally 45mg twice daily for 28 consecutive days
RECRUITING
St. Luke's University Health Network, Easton
RECRUITING
Vanderbilt-Ingram Cancer Center, Nashville
RECRUITING
Markey Cancer Center, Lexington
NOT_YET_RECRUITING
University of Iowa, Iowa City
Collaborators (1)
Novartis
INDUSTRY
National Cancer Institute (NCI)
NIH
Ruta Arays
OTHER