Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

July 1, 2027

Study Completion Date

June 1, 2029

Conditions
Metastatic MelanomaBRAF Gene Mutation
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

Dabrafenib

All patients will begin dabrafenib (150mg PO BID) on day one and will continue for 28 days.

DRUG

Trametinib

All patients will begin trametinib (2mg PO once daily) on day one and will continue for 28 days.

DRUG

Encorafenib

encorafenib will be administered orally 450mg once daily for 28 consecutive days

DRUG

Binimetinib

binimetinib will be administered orally 45mg twice daily for 28 consecutive days

Trial Locations (4)

18045

RECRUITING

St. Luke's University Health Network, Easton

37232

RECRUITING

Vanderbilt-Ingram Cancer Center, Nashville

40536

RECRUITING

Markey Cancer Center, Lexington

52242

NOT_YET_RECRUITING

University of Iowa, Iowa City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Ruta Arays

OTHER

NCT04903119 - Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma | Biotech Hunter | Biotech Hunter