The main purpose of this study is to Evaluate the Efficacy and Safety of the combination of HL-085 and Vemurafenib in Advanced Melanoma Patients with BRAF V600E/K Mutation. This study includes IIa and IIb phase. Phase IIa will determine the dose regiment for Phase IIb. Phase IIb part will evaluate the efficacy and safety with this combination regiment.
This is a single-arm, multi-center Phase II trial to evaluate the efficacy and safety of the combination of HL-085 and Vemurafenib in advanced melanoma patients with BRAF V600E/K mutation. There are two phase of this study ( IIa and IIb). Phase IIa will be evaluating the safety and efficacy of the combination regiment (HL-08512mg +Vemurafenib 720mg, and/or some lower dose regiment, such as 9mg+720mg) in 20-30 patients, and final determine the recommended dose regiment for Phase IIb. In Phase IIb will enrolled 74 patients , the primary endpoint is ORR, and the secondary endpoint are PFS. The safety profile of this combined HL-085/Vemurafenib regimen will be monitored during both phases. The treatment period consists of 21-day cycles until progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
HL-085 capsule 12mg administered orally twice daily in a 21-day treatment cycle
Vemurafenib tablet 720mg administered orally twice daily in a 21-day treatment cycle
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective response rate (ORR)
Objective response rate (ORR)as measure of efficacy by RECIST 1.1
Time frame: up to 24 months
Progression Free survival (PFS)
Defined as the time from first dosing (C1D1) to date of first observed progression or death from any cause (whichever comes first)
Time frame: up to 24 months
Disease control rate(DCR)
Defined as the percentage of patients who have achieved a confirmed response of at least CR or PR or a response of SD
Time frame: up to 24 months
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