Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma: A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of recurrence-free survival
研究概览
简要总结
This study will investigate whether the use of talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma.
详细描述
This is a prospective, non-randomized, open-label, single-center interventional study looking at the response rate when using talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor in neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma. For this pilot study, a sample size of 20 participants, over 18 years of age will be included.
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
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
- 未提供
研究组 & 干预措施
T-Vec + BRAF/MEK
Participants will begin taking the following 3 medications:
BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10^6 PFU/mL; Dose #2: 10^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10^8 PFU/mL every 14 (+/-3) days).
Dosing to continue for at least 3 months, or up to 6 months if no plateau in response.
May stop earlier than 3 months at physician discretion depending on side effects and response.
Ultrasound of tumor nodal basin(s) monthly.
Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months.
PET CT or brain MRI as needed at discretion of the investigator.
Manual tumor measurement in office prior to each injection.
干预措施: Talimogene laherparepvec (T-Vec) (Drug)
T-Vec + BRAF/MEK
Participants will begin taking the following 3 medications:
BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10^6 PFU/mL; Dose #2: 10^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10^8 PFU/mL every 14 (+/-3) days).
Dosing to continue for at least 3 months, or up to 6 months if no plateau in response.
May stop earlier than 3 months at physician discretion depending on side effects and response.
Ultrasound of tumor nodal basin(s) monthly.
Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months.
PET CT or brain MRI as needed at discretion of the investigator.
Manual tumor measurement in office prior to each injection.
干预措施: Dabrafenib (BRAF Inhibitor) (Drug)
T-Vec + BRAF/MEK
Participants will begin taking the following 3 medications:
BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10^6 PFU/mL; Dose #2: 10^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10^8 PFU/mL every 14 (+/-3) days).
Dosing to continue for at least 3 months, or up to 6 months if no plateau in response.
May stop earlier than 3 months at physician discretion depending on side effects and response.
Ultrasound of tumor nodal basin(s) monthly.
Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months.
PET CT or brain MRI as needed at discretion of the investigator.
Manual tumor measurement in office prior to each injection.
干预措施: Trametinib (MEK Inhibitor) (Drug)
结局指标
主要结局
Rate of recurrence-free survival
时间窗: 1 year
次要结局
- Rate of pathological response in the surgical specimen(6 months)
- Rate of distant metastatic free survival(3 years)
- Tumor response rate to therapy according to RECIST criteria(6 months)
- Incidence of all adverse events (AEs)(7 months)
- Rate of melanoma specific survival(3 years)