NCT03425565已完成2 期
A Phase II Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Progression Free Survival at 12 Weeks
研究概览
简要总结
PEACOCC is a multi-centre, single arm, single stage phase II trial. The overall aim is to determine whether treatment with pembrolizumab is effective in patients with advanced clear cell gynaecological cancer.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Histological diagnosis of advanced clear cell ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer.
- •Have measurable disease based on RECIST 1.
- •Evidence of radiological disease progression.
- •Patient is willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion at baseline, 6-8 weeks after start of treatment and at the time of progression.
- •ECOG Performance Status 0 or
- •Patient has a life expectancy of at least 3 months from consent.
- •Received ≥ 1 line of prior chemotherapy .
排除标准
- •Has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses > 10mg prednisolone daily or equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •Has a known history of active TB (Bacillus Tuberculosis), Hepatitis B (e.g., HBsAg reactive), Hepatitis C or a known history of Human Immunodeficiency Virus (HIV).
- •Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids (at a dose >10mg predisolone daily or equivalent) or immunosuppressive drugs).
- •Has known history or evidence of active, non-infectious pneumonitis.
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •Has received a live vaccine within 30 days prior to the planned start of trial treatment.
研究组 & 干预措施
Pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Progression Free Survival at 12 Weeks
时间窗: 12 weeks
The proportion of progression-free participants is defined as the number of participants alive with complete or partial response or stable disease maintained at 12 weeks (as assessed by the site radiologist and/or investigator, using RECIST v1.1) divided by the number of participants in the analysis population. Only participants with tumour assessment at or beyond 12 weeks were considered progression-free. All eligible participants who received at least one cycle of pembrolizumab were included in the analysis population. Any patient found to be ineligible will be excluded and replaced.
次要结局
- Progression-free Survival(Time from start of trial treatment to progression or death from any cause (whichever came first).)
- Time to Second Disease Progression (Re-treatment Period)(Time from diagnosis of first progression during or after their initial pembrolizumab therapy to second progression or death from any cause (whichever came first), during or after their retreatment pembrolizumab.)
- Overall Survival(Time from start of treatment to death from any cause.)
- Objective Response at 12 Weeks(12 weeks post start of treatment)
- Best Objective Response Rate(Time from start of treatment until last tumour assessment. Tumour imaging was performed at baseline, week 6, week 12 and then repeated every 12 weeks during trial treatment and follow-up; on average the last response assessment was at 12 weeks.)
- Duration of Response(Time from initial complete or partial response to disease progression or death on study from any cause (defined as death within 110 days of the last study treatment), whichever occurred first.)
- Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) Total Score(Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.)
- Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Physical Well-being (PWB)(Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.)
- Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Social Well-being (SWB)(Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.)
- Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Emotional Well-being (EWB)(Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.)
- Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Functional Well-being (FWB)(At end of treatment from baseline (before start of treatment), an average of 20 weeks.)
- Quality of Life (QoL): The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) - Ovarian Cancer Sub-scale (OCS)(Change at end of treatment from baseline (before start of treatment), an average of 20 weeks.)
研究者
研究点 (5)
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