Melanoma Clinical Trial
Official title:
Study of CDX-3379, a Human Monoclonal Antibody Targeting ERBB3, in Combination With the MEK Inhibitor, Trametinib, in Patients With Advanced Stage NRAS Mutant and BRAF/NRAS Wildtype (WT) Melanoma
The main goal of this study is to test if it is safe and effective to give CDX-3379 together to treat advanced melanoma in patients with the NRAS mutation and BRAF/NRAS wildtype.
Primary Objectives:
Phase 1b: To determine the RP2D and assess the toxicity and tolerability of the combination
of CDX-3379 (ERBB3 antibody) and trametinib (MEK inhibitor) in NRAS and BRAF/NRAS WT melanoma
patients
Phase 2: To estimate the response rates and duration of response of the combination of
CDX-3379 (ERBB3 antibody) and trametinib in NRAS positive and BRAF/NRAS WT melanoma patients
Secondary/Exploratory Objectives:
Phase 1b: To assess clinical activity and steady-state pharmacokinetics of CDX-3379 and
trametinib Phase 2: To compare the efficacy of the combination of CDX-3379 (ERBB3 antibody)
and trametinib is more effective than a MEK inhibitor alone in NRAS positive and BRAF/NRAS WT
melanoma patients alone using locally assessed progression free survival (PFS) and overall
survival (OS).
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