Neoadjuvant Vemurafenib and Cobimetinib in BRAF V600 Mutant Stage IIIB-C Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Radiologic Complete Response Rate
研究概览
简要总结
Neoadjuvant Vemurafenib and Cobimetinib in BRAF V600 Mutant Stage IIIB-C Melanoma
• To evaluate the overall radiological complete response rate in patients with stage IIIB/C melanoma after 8 weeks of neoadjuvant vemurafenib and cobimetinib
详细描述
Vemurafenib and cobimetinib are FDA-approved drugs to treat advanced melanoma that has a mutated (changed) form of a cell protein called BRAF (BRAF V600 mutation). The purpose of this study is to determine if vemurafenib and cobimetinib can be safely given to patients with this type of melanoma to shrink it before surgery. This research is being done because patients with melanoma spread to lymph node have high chance of melanoma recurrence even after lymph node removal surgery, and currently there is no approved medicine to use for patients with BRAF V600 mutant melanoma before lymph node removal surgery.
Vemurafenib and cobimetinib as a combination has been approved by the United States Food and Drug Administration (FDA) for patients with more advanced melanoma. In this trial, vemurafenib and cobimetinib combination is considered to be experimental since safety of this combination prior to lymph node surgery has not been studied.
Before the participant begins the study:
The participant will need to have the following exams, tests or procedures to find out if eligibility is met.
- A skin exam
- An eye exam
- An electrocardiogram (ECG) which is a test that tracks the electricity of the heart
- An echocardiogram (a test that uses sound waves to create pictures of the heart) or MUGA scan (a test that uses radioactive materials called tracers to show the heart chambers) which is a test to evaluate the function of the heart
- A blood test
- A biopsy of lymph node
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Had prior radiotherapy at lymph node basin
- •Prior treatment with BRAF inhibitor or MEK inhibitor
- •Active infection
- •Pregnant, lactating or breast feeding women
- •Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- •History of malabsorption or other condition that would interfere with absorption of vemurafenib or cobimetinib
- •Any underlying medical or psychiatric condition, which in the opinion of the Investigator will make the administration of vemurafenib and cobimetinib hazardous
- •Unwillingness or inability to comply with study and follow-up procedures.
- •The following foods/supplements are prohibited at least 7 days prior to initiation of and during study treatment:
- •St. John's wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)
- •Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor)
研究组 & 干预措施
Vemurafenib/Cobimetinib
Vemurafenib and cobimetinib as a combination has been approved by the United States Food and Drug Administration (FDA) for patients with more advanced melanoma. In this trial, vemurafenib and cobimetinib combination is considered to be experimental since safety of this combination prior to lymph node surgery has not been studied.
干预措施: Vemurafenib and Cobimetinib (Drug)
结局指标
主要结局
Radiologic Complete Response Rate
时间窗: Day 56 (+/- 3 days)
Radiologic complete response rate will be the primary endpoint. This will be assessed after completion of the 8-week treatment of vemurafenib and cobimetinib by CT measurements of tumor diameter pre-treatment and at day 56 (± 3 days) using RECIST 1.1. Complete response (CR) is defined by a reduction in the short-axis diameter of any pathologic lymph node to less than 10 mm, whereas partial response (PR) is defined as 30% or more decrease in the short axis. The analysis of response rate is based on the efficacy evaluable patients who has post-treatment CT scan at Day 43. Patients who discontinued study drug or withdraw from the study will be included only if they had post-treatment CT scan. We will calculate radiologic complete response rate with 95% confidence interval.
次要结局
- Overall response rate, pathologic complete response rate(Day 56 (+/- 3 days))