HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation (NCT05263453) | Clinical Trial Compass
UnknownPhase 2
HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation
China104 participantsStarted 2021-09-06
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Male or female patients ≥ 18 years of age;
* Patients with histological confirmed advanced melanoma;
* BRAF V600E/ V600K mutation positiveï¼›
* At least 1 site of radiographically measurable disease by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 1;
* Life expectancy ≥ 3 months;
* Can swallow the medicine,
* UCG documenting LVEF ≥50% within seven days prior to initiation of dosing;
* Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 1.0 x lower limit of normal (LLN); Hemoglobin ≥ 90 g/L; Serum creatinine ≤ 1.5 x upper limit of normal (ULN); Serum aspartate transaminase (AST) or serum alanine transaminase (ALT)≤ 2.5x ULN, and ≤ 5.0 x ULN if liver metastases are present. Serum alkaline phosphatase (ALP)≤ 2.5x ULN and ≥ 2.5 x ULN if bone metastases are present; Total serum bilirubin ≤ 1.5 x ULN; Serum albumin ≥ 30 g/L; Coagulation function:INR ≤1.5×ULN;Activated partial thrombin time (APTT) ≤1.5×ULN; Creatine kinase (CK) ≤1× ULN
* 10\. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
* 11\. Be willing and able to complete all the study procedures and follow-up examinations.
Exclusion Criteria:
* Patients who have been previously treated with a BRAF and/or MEK inhibitors.
* Patients with act…