A Randomized, Open-label, Two-arm, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of PRGN-2009 in Combination With Pembrolizumab Versus Pembrolizumab Monotherapy in Patients With Recurrent or Metastatic Cervical Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
研究概览
简要总结
This randomized trial will evaluate the efficacy and safety of PRGN-2009 in combination with pembrolizumab compared to pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
详细描述
This is a randomized, two-arm study of PRGN-2009 in patients with recurrent or metastatic cervical cancer who are pembrolizumab resistant. Patients meeting all eligibility criteria who consent to participate in the study will be randomized 1:1 to receive a combination of PRGN-2009, plus pembrolizumab, or to receive pembrolizumab alone.
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
- •Age 18 years and older.
- •Recurrent or metastatic cervical cancer (histologically or cytologically confirmed) that meets the criteria of pembrolizumab-resistant.
- •Must have been treated with pembrolizumab, either as monotherapy or in combination
- •Patients must have received no more than two prior systemic regimens in the recurrent or metastatic setting
- •Tumors are confirmed positive for PD-L1 and HPV16/18
- •Measurable disease that can be accurately measured by RECIST v1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 12 weeks from the time of enrollment.
- •Must have adequate organ function
- •Negative serum pregnancy test. Women of child-bearing potential (WOCBP) must agree to use adequate contraception prior to study entry and for at least 6 months following completion of study treatment.
- •All patients must have the ability to understand and willingness to sign a written informed consent.
排除标准
- •Patients with presence of other active malignancy within 1 year prior to study entry
- •Known Central Nervous System (CNS) disease
- •Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- •Known history of active tuberculosis (TB, Bacillus tuberculosis).
- •Pregnant and lactating women are excluded from this study.
- •Patients with a history of solid organ transplant.
- •Patients currently participating in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment.
- •Patients, who in the opinion of the investigator, may not be able to comply with the monitoring requirements of the study.
研究组 & 干预措施
PRGN-2009 plus Pembrolizumab
PRGN-2009 at a dose of 5 x 10^11 PU q3W for 3 administrations, then q6w, plus Pembrolizumab, 400mg q6w
干预措施: PRGN-2009 plus Pembrolizumab (Biological)
Pembrolizumab alone
Pembrolizumab, 400mg q6w
干预措施: Pembrolizumab alone (Drug)
结局指标
主要结局
Determine the Objective Response Rate (ORR) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone in patients with pembrolizumab-resistant recurrent or metastatic cervical cancer.
时间窗: 1 year
The ORR will be calculated as the combination of subjects achieving a complete response or a partial response per RECIST v1.1. ORR will be calculated and presented with 2-sided 95% confidence interval.
次要结局
- Time to Response and Duration of Responses following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone(1 year)
- Vector shedding following subcutaneous administration of PRGN-2009(Up to 4 months)
- Safety of PRGN-2009 in combination with pembrolizumab or pembrolizumab alone(1 year)
- Progression-Free Survival (PFS) and Overall Survival (OS) following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone(1 year)
- Best Overall Responses (BOR) and Disease Control Rate (DCR) per RECIST v1.1 following treatment with PRGN-2009 in combination with pembrolizumab or pembrolizumab alone(1 year)