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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients ≥ 18 years of age;
* Patients with histological confirmed advanced melanoma;
* BRAF V600E/ V600K mutation positive；
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.