ALK Fusion Protein Expression Clinical Trial
Official title:
A Phase II Trial of Targeted Kinase Fusion Inhibition in Unresectable Stage III/IV BRAF/NRAS Wild-Type Melanoma
This phase II trial studies how well capmatinib, ceritinib, regorafenib, or entrectinib work in treating patients with BRAF/NRAS wild-type stage III-IV melanoma. Capmatinib, ceritinib, regorafenib, or entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To estimate the clinical activity of tyrosine kinase inhibitors matched to the
tumor-specific fusion kinase in patients with metastatic melanoma.
SECONDARY OBJECTIVES:
I. To estimate tumor stability in melanoma patients treated with kinase inhibitors matched to
the tumor-specific fusion kinase.
II. To estimate survival in melanoma patients treated with kinase inhibitors matched to the
tumor-specific fusion kinase.
III. To examine the safety and tolerability of kinase inhibitors in patients with melanoma
with a fusion kinase.
TERTIARY OBJECTIVES:
I. To explore molecular mechanisms of resistance for patients who progress on therapy.
OUTLINE: Patients are assigned to 1 of 4 arms.
ARM A: Patients with MET fusion receive capmatinib orally (PO) twice daily (BID) on day 1-28.
Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
ARM B: Patients with ALK fusion receive ceritinib PO once daily (QD) on days 1-28. Courses
repeat every 28 days in the absence of disease progression or unaccepted toxicity.
ARM C: Patients with RET or BRAF fusion receive regorafenib PO QD on day 1-21. Courses repeat
every 28 days in the absence of disease progression or unaccepted toxicity.
ARM D: Patients with NTRK1, NTRK2, NTRK3, or ROS1 fusion receive entrectinib PO QD on days
1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted
toxicity.
After completion of study treatment, patients are followed up within 30 days and then
periodically.
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