An Extension Protocol to Evaluate the Efficacy and Safety of Extended Use Treatment With OncoVEX^GM-CSF for Eligible Melanoma Patients Participating in Study 005/05
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (NCT00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Previously participated in protocol 005/05 (NCT00769704) and:
- •received the maximum number of talimogene laherparepvec treatment injections or cycles of GM-CSF allowable for that patient on study 005/05, or
- •new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/
- •New injectable lesions must have appeared within ≤ 12 months from the End of Treatment visit on the 005/05 study.
- •In the opinion of the investigator and the sponsor's medical monitor further treatment is warranted [e.g., those patients who do not have clinically relevant progressive disease (PDr)].
- •Performance status (Eastern Cooperative Oncology Group, ECOG) 0 or
- •For patients randomized to talimogene laherparepvec only: Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. There is no minimum size for injection.
排除标准
- •Prior Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or 4 toxicity related to talimogene laherparepvec of any organ system (with the exception of injection site reactions, fever and vomiting).
- •History of Grade 3 fatigue lasting > 1 week while on talimogene laherparepvec treatment.
- •History of Grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment.
- •History of ≥ Grade 2 autoimmune reactions, allergic reactions or urticaria or other talimogene laherparepvec related non-hematological toxicities while on talimogene laherparepvec treatment that required a dose delay or discontinuation of talimogene laherparepvec therapy.
- •PDr while participating in study 005/05
- •Patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial.
- •At the discretion of the investigator, patient was withdrawn from the 005/05 trial.
研究组 & 干预措施
GM-CSF
Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
干预措施: Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF) (Drug)
Talimogene Laherparepvec
Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
干预措施: Talimogene Laherparepvec (Biological)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (AEs)
时间窗: From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.
AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE. Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator. A serious AE is one that meets one or more of the following criteria/outcomes: * Results in death. * Is life-threatening. * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in persistent or significant disability/incapacity. * Is a congenital anomaly/birth defect. * Is an important medical event.
次要结局
- Objective Response Rate(From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.)
- Durable Response Rate(From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.)