II 期:上皮性卵巢癌中的派姆单抗/卡铂/紫杉醇
抗 PD 1 疗法 Pembrolizumab 联合一线铂类化疗后进行 12 个月 Pembrolizumab 单药治疗 III/IV 期上皮性卵巢癌患者的 II 期开放标签非随机试验
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Ohio
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Cleveland、Ohio、美国
- Cleveland Clinic
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Medical College of Wisconsin and Froedtert Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 患有晚期 III/IV 期上皮性卵巢癌、输卵管癌或原发性腹膜癌
- 愿意并能够为试验提供书面知情同意/同意。
- 在签署知情同意书之日年满 18 岁。
- 根据 RECIST 1.1,次优细胞减灭术定义为根据手术报告记录的任何残留疾病和/或具有可测量/宏观疾病(定义为目标和/或非目标病变)。
- 愿意提供来自新获得的肿瘤病变核心或切除活检的组织。 新获得的样本定义为在第 1 天开始治疗前最多 6 周(42 天)获得的标本。无法为其提供新获得样本的受试者(例如 无法访问或存在安全问题)只有在申办者同意的情况下才能提交存档样本。
- ECOG 体能量表的体能状态为 0、1 或 2。
- 展示足够的器官功能
- 所有筛选实验室应在治疗开始后 28 天内进行。
- 有生育能力的女性受试者在接受首次研究药物治疗前 72 小时内的尿液或血清妊娠应为阴性。
- 有生育能力的女性受试者应愿意使用 2 种节育方法或进行手术绝育,或在研究过程中直至最后一次研究药物给药后 120 天内停止异性恋活动。
排除标准:
- 目前正在参与和接受研究治疗,或已参与研究药物的研究并接受研究治疗或在首次治疗后 4 周内使用研究设备。
- 在第一次试验治疗前 7 天内被诊断为免疫缺陷或正在接受全身性类固醇治疗或任何其他形式的免疫抑制治疗。
- 有已知的活动性结核病史(结核杆菌)
- 对派姆单抗或其任何赋形剂过敏。
- 在研究第 1 天之前的 4 周内曾使用过抗癌单克隆抗体 (mAb) 或未从 4 周前服用药物引起的不良事件中恢复(即,≤ 1 级或基线)。
在研究第 1 天之前的 2 周内接受过化疗、靶向小分子治疗或放射治疗,或因先前使用药物引起的不良事件尚未恢复(即≤ 1 级或基线)。
- 注意:如果受试者接受了大手术,他们必须在开始治疗之前从干预的毒性和/或并发症中充分恢复。
- 有需要类固醇治疗的(非感染性)肺炎病史或目前患有肺炎。
- 在过去 3 年内患有已知的其他恶性肿瘤,或者正在进展或需要积极治疗。 例外情况包括皮肤基底细胞癌或已经过潜在治愈性治疗的皮肤鳞状细胞癌或原位宫颈癌。
- 已知有活动性中枢神经系统 (CNS) 转移和/或癌性脑膜炎。
- 在过去 2 年中患有需要全身治疗的活动性自身免疫性疾病(即使用疾病调节剂、皮质类固醇或免疫抑制药物)。 替代疗法(例如,甲状腺素、胰岛素或生理性皮质类固醇替代疗法用于肾上腺或垂体功能不全等)不被视为全身治疗的一种形式。
- 有需要全身治疗的活动性感染。
- 有任何病症、治疗或实验室异常的病史或当前证据,这些异常、治疗或实验室异常可能会混淆试验结果,干扰受试者在整个试验期间的参与,或不符合受试者的最佳利益,在治疗研究者看来。
- 具有病史或先前未另行指定的病症的患者,研究者认为应排除参与本研究。 调查员应咨询研究主席。
- 已知会干扰配合试验要求的精神或物质滥用障碍。
- 从预筛查或筛查访视开始到最后一剂试验治疗后的 120 天内怀孕或哺乳,或预期在试验的预计持续时间内怀孕。
- 之前接受过抗 PD-1、抗 PD-L1 或抗 PD-L2 药物的治疗。
- 有人类免疫缺陷病毒 (HIV)(HIV 1/2 抗体)的已知病史。
- 已知患有活动性乙型肝炎(例如,HBsAg 反应性)或丙型肝炎(例如,检测到 HCV RNA [定性])。
- 患有交界性卵巢肿瘤、复发性上皮性卵巢癌/原发性腹膜癌/输卵管癌或非上皮性卵巢癌的患者不符合资格。
- 在计划开始研究治疗后的 30 天内接受过活疫苗接种。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:化疗联合派姆单抗
单臂研究: Pembrolizumab IV 每 21 天一次 (200 mg) Carboplatin IV 每 21 天一次 紫杉醇 IV 输注 (80 mg/m2) 每 7 天一次,共 6 个周期 随后 12 个月 pembrolizumab IV 每 21 天一次 |
IV 每 21 天 200 mg
其他名称:
每 21 天静脉注射一次
其他名称:
每 7 天静脉滴注 (80mg/m2),共 6 个周期
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
上皮性卵巢癌 (EOC) 患者联合铂类治疗与抗程序性死亡 (PD)-1 治疗随后进行维持性抗 PD-1 治疗的无进展生存期 (PFS)。
大体时间:从完成主要治疗之日起至首次出现疾病进展或因任何原因导致死亡的临床、生化或放射学证据之日止
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无进展生存期 (PFS) 是从进入研究(第一剂治疗)到疾病进展、死亡或最后一次接触日期的时间。 所有患者在开始治疗前均接受基线计算机断层扫描。 残留疾病信息是从外科手术报告以及术后 CT 扫描中收集的。 在每个治疗周期用 CA 125 评估治疗反应。 术后开始全身治疗前、铂类、紫杉烷和派姆单抗联合治疗完成时以及派姆单抗维持治疗完成时进行 CT 扫描。 还以增加的 CA 125 进行 CT 扫描,或者如果每位治疗医生有临床指征,并使用实体瘤 (RECIST) 标准中的反应评估标准进行评估,定义为目标病灶最长直径总和增加 20%,或可测量非目标l增加 |
从完成主要治疗之日起至首次出现疾病进展或因任何原因导致死亡的临床、生化或放射学证据之日止
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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通过抗 PD-1 治疗的联合治疗和单药维持治疗期间的生活质量,以及治疗期间定期进行的癌症治疗功能评估 - 卵巢 (FACT-O) 调查。
大体时间:入组时间至治疗开始后 18 个月
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每个周期为21天。 所有参与者都被要求在基线/入组时、治疗开始后 3 个月、6 个月和 18 个月时完成 FACT-O 调查。 FACT-O 是经过验证的 26 项总分 112 分,涵盖了身体健康(7 项)、功能健康(7 项)和卵巢癌子量表的 FACT-General (FACT-G) 生活质量维度(12 项)。 FACT-0 是一项包含 39 个项目的自我管理调查。 每个项目均按 5 点李克特量表评分。 FACT-0 评分范围为 0-44。 FACT-G 的子量表评分范围为 0-108。 总分越高,患者的健康状况越好。 结果测量数据代表 FACT-G 评分,因为它是与 QOL 相关的部分。 https://www.facit.org/measures/FACT-O |
入组时间至治疗开始后 18 个月
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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患者初次诊断时获得的保存组织中的 PD-L1 表达
大体时间:在登记时,将从细胞减灭手术获得的组织从病理块中获得。
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使用初始肿瘤样本的免疫组织化学 (IHC) 方法,在初次诊断细胞减灭性卵巢癌患者时获得的保存组织中的 PD-L1 表达,并与临床反应和生存结果相关。
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在登记时,将从细胞减灭手术获得的组织从病理块中获得。
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合作者和调查者
调查人员
- 首席研究员:Denise Uyar, MD、Medical College of Wisconsin
出版物和有用的链接
一般刊物
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研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (估计的)
上次提交的符合 QC 标准的更新
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与本研究相关的术语
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其他研究编号
- Uyar 25680 IIT Merck
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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