Recurrent Melanoma Clinical Trial
Official title:
A Phase II Trial of MAP Kinase Inhibition With AZD6244 Hydrogen Sulfate in Combination With MK-2206 (Akt Inhibitor) in Patients With BRAF V600-Mutant Advanced Melanoma Whose Disease Has Progressed on Prior Therapy With a Selective BRAF Inhibitor (i.e., Vemurafenib, Dabrafenib, LGX818)
This phase II trial studies how well selumetinib and Akt inhibitor MK2206 works in treating patients with stage III or stage IV melanoma who failed prior therapy with vemurafenib or dabrafenib. Selumetinib and Akt inhibitor MK2206 stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether giving selumetinib and Akt inhibitor MK2206 together is an effective treatment for advanced melanoma.
PRIMARY OBJECTIVES:
I. To determine the frequency of objective clinical responses by RECIST 1.1 for these
melanoma patients who have previously progressed on selective BRAF inhibitors when treated
with MEK inhibitor, AZD6244 hydrogen sulfate plus Akt inhibitor, MK-2206.
II. To further characterize toxicities of both regimens in these patients who have
progressed after BRAF inhibitor therapy.
SECONDARY OBJECTIVES:
I. With required fresh pretreatment biopsies on all patients, we plan to characterize the
molecular state (genetic and proteomic) associated with BRAF inhibitor resistance. This may
include an analysis of pathway activation, PI3/Akt or MAP kinase pathway; loss of expression
of PTEN, secondary mutations in BRAF, other mutations in the MAP kinase pathway (NRAS, KRAS,
HRAS, CRAF, MEK), activation of other RTKs (amplification, over expression,
phosphorylation).
OUTLINE:
Patients receive selumetinib orally (PO) twice daily (BID) on days 1-21 and Akt inhibitor
MK2206 PO once weekly.
After completion of study treatment, patients are followed up every 12 weeks.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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