Neoadjuvant Combination Immunotherapy for Stage III Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.
详细描述
This is a single arm Phase 2 study of pre-operative combination immunotherapy with pembrolizumab and T-VEC given for 6 months prior to complete lymph node dissection for stage 3 resectable cutaneous melanoma with clinically apparent lymph node metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma
- •ECOG performance status of 0 or 1
- •Adequate hematologic, hepatic, renal and coagulation function
- •Must have measurable disease and have an injectable target lymph node for intralesional therapy administration
- •Primary melanoma has been resected
- •Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist.
- •Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.
- •BRAF mutant or wild type allowed (mutations status not necessary for enrollment)
- •Signed, written informed consent
排除标准
- •Cannot have metastatic (AJCC M1) disease
- •No primary mucosal or uveal melanoma
- •No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years
- •May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor
- •Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression
- •Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use
研究组 & 干预措施
Combination T-VEC/Pembrolizumab
Pre-operative talimogene laherparepvec (T-VEC) with Pembrolizumab
T-VEC - intra-lesional injection into palpable lymph nodes every 3 weeks for 6 months, or until complete response of target tumors.
Pembrolizumab - administered intravenously every 3 weeks for 6 months, then every 3 weeks for one year in the adjuvant setting following complete lymph node dissection.
干预措施: Pembrolizumab (Drug)
Combination T-VEC/Pembrolizumab
Pre-operative talimogene laherparepvec (T-VEC) with Pembrolizumab
T-VEC - intra-lesional injection into palpable lymph nodes every 3 weeks for 6 months, or until complete response of target tumors.
Pembrolizumab - administered intravenously every 3 weeks for 6 months, then every 3 weeks for one year in the adjuvant setting following complete lymph node dissection.
干预措施: Talimogene Laherparepvec (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: 6 months
Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection
次要结局
- Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events(Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years)
研究者
Michael Egger
Principal Investigator
University of Louisville