NCT07816666尚未招募3 期
A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan With or Without Bevacizumab Versus Standard of Care as Second- or Third-Line Maintenance Treatment in Participants With Platinum-sensitive Relapsed Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-03)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 600
- 试验地点
- 79
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to measure the efficacy and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to standard of care (SoC) as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer (PSR OC)
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer.
- •Provision of an archival FFPE tumour sample
- •Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy.
- •Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment
- •Participants who received at least 6 cycles of PBC during the induction phase of their current line of treatment.
- •Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation.
- •Participants with non-progressive disease upon completion of PBC in their current line of treatment.
- •Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance).
排除标准
- •Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, or low-grade epithelial tumours.
- •Participants with history of (non-infectious) ILD/pneumonitis that required steroids, or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening
- •Participants with non-healing wound, active ulcer, or bone fracture (not applicable if not receiving bevacizumab)
- •Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab)
- •Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)
研究组 & 干预措施
Torvutatug samrotecan monotherapy or in combination with bevacizumab
Experimental
Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV.
干预措施: Torvutatug samrotecan (Drug)
Torvutatug samrotecan monotherapy or in combination with bevacizumab
Experimental
Torvutatug samrotecan monotherapy intravenous (IV) or Torvutatug samrotecan IV with bevacizumab IV.
干预措施: Bevacizumab (Drug)
Observation or bevacizumab
Active Comparator
Observation or bevacizumab IV.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 5 years
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review, or death due to any cause.
次要结局
- Overall Survival (OS)(Up to approximately 5 years)
- Second Progression-Free Survival (PFS2)(Up to approximately 5 years)
- Time to First Subsequent Therapy (TFST)(Up to approximately 5 years)
- Time to Second Subsequent Therapy (TSST)(Up to approximately 5 years)
- Health-related Quality of Life (HrQoL)(Up to approximately 5 years)
- Number and percentage of participants with adverse events as graded by CTCAE v6 criteria(Up to approximately 5 years)
研究者
研究点 (79)
Loading locations...
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