NCT00070642已完成2 期
ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 184
- 主要终点
- Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
研究概览
简要总结
To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.
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
- •Histologically or cytologically confirmed melanoma that is metastatic.
- •Measurable disease according to the RECIST criteria.
- •Karnofsky Performance Status of > 70.
排除标准
- •Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC).
- •Suspected or known CNS metastases.
研究组 & 干预措施
Chemotherapy alone
Active Comparator
dacarbazine
干预措施: Chemotherapy (Drug)
CPG 7909 Injection 10 mg
Experimental
干预措施: CPG 7909 Injection (Drug)
CPG 7909 Injection plus chemotherapy
Experimental
CPG 7909 Injection plus DTIC
干预措施: CPG 7909 Injection (Drug)
CPG 7909 Injection plus chemotherapy
Experimental
CPG 7909 Injection plus DTIC
干预措施: dacarbazine (Drug)
CPG 7909 Injection 40 mg
Experimental
干预措施: CPG 7909 Injection (Drug)
结局指标
主要结局
Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
时间窗: indeterminate
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
时间窗: Indeterminate
次要结局
- Phase III: Assess the overall response rate(indeterminate)
- Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.(indeterminate)
- Determine the duration of response.(indeterminate)
- Determine the time to progression(indeterminate)
- Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only).(indeterminate)
- Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone(indeterminate)
研究者
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