Study to Assess the Efficacy and Safety of Rina-S With or Without Bevacizumab Compared to Investigator's Choice of Platinum-based Chemotherapy With or Without Bevacizumab as Second-line Treatment in Participants With Recurrent Platinum-sensitive Ovarian Cancer (RAINFOL™-07)
A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer
This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.
The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.
Participants will receive either:
- Rina-S monotherapy (by itself),
- Rina-S plus bevacizumab,
- investigator's choice chemotherapy (by itself) (standard of care), or
- investigator's choice chemotherapy plus bevacizumab (standard of care).
No participants will be given placebo. Participants will participate in 1 of 2 arms.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.
The overall study duration (including screening, treatment, and follow-up) will be different for every participant.
研究概览
详细说明
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Genmab Trial Information
- 电话号码:+4570202728
- 邮箱:clinicaltrials@genmab.com
学习地点
-
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Connecticut
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Danbury、Connecticut、美国、06810
- 招聘中
- Danbury Hospital
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Wisconsin
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Waukesha、Wisconsin、美国、53188
- 招聘中
- Prohealth Care Inc
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Key Inclusion Criteria:
- Participant must have histologically confirmed high-grade serous or endometrioid epithelial ovarian cancer (EOC), including primary peritoneal or fallopian tube cancer.
- Participant must have documented recurrence or progression after first-line (1L) platinum-based chemotherapy regimen (carboplatin + paclitaxel ≥ 4 cycles) with or without bevacizumab and have platinum-sensitive disease defined as radiographic progression at least 6 months (ie, >183 days) after their last dose administration of platinum-based therapy.
- Prior poly (ADP-ribose) polymerase inhibitor(s) (PARPi) maintenance therapy (alone or in combination with bevacizumab) is required for participants with breast cancer susceptibility gene (BRCA 1- and BRCA 2)-mutated (germline or somatic) or homologous recombination deficiency (HRD)-positive disease.
- Participants must have measurable disease per RECIST v1.1 by investigator at baseline.
- All participants must provide a tumor specimen.
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at baseline.
Key Exclusion Criteria:
- Participants with clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade/borderline ovarian tumors.
- Participant has received previous therapy with other anti-angiogenetic agents different from bevacizumab or biosimilar.
- Participant has received prior therapy with an antibody-drug conjugate (ADC) containing a topoisomerase-1 inhibitor.
- Participant has received prior therapy with an ADC targeting folate receptor alpha (FRα).
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 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:Arm 1: Rina-S ± Bevacizumab
Participants will receive Rina-S ± bevacizumab once every 3 weeks (Q3W).
|
静脉输液
Intravenous (IV) infusion
其他名称:
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有源比较器:Arm 2: Investigator Choice of Chemotherapy ± Bevacizumab
Participants will receive carboplatin plus gemcitabine ± bevacizumab, carboplatin plus paclitaxel ± bevacizumab, or carboplatin plus pegylated liposomal doxorubicin (PLD) ± bevacizumab.
|
静脉输液
静脉输液
静脉输液
静脉输液
IV infusion
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
大体时间:Up to approximately 3 years
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Up to approximately 3 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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总生存期(OS)
大体时间:最长约 5 年
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最长约 5 年
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根据 RECIST v1.1 的响应持续时间 (DOR)
大体时间:最长约3年
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最长约3年
|
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患有治疗效果不良事件(TEAE)的参与者数量
大体时间:大约3年
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大约3年
|
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PFS per RECIST v1.1, as Determined by Investigator
大体时间:Up to approximately 3 years
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Up to approximately 3 years
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Objective Response Rate (ORR) per RECIST v1.1
大体时间:Up to approximately 3 years
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Up to approximately 3 years
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Progression-free Survival on the Next Line of Therapy After the First Progression (PFS2)
大体时间:Up to approximately 3 years
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Up to approximately 3 years
|
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Time to First Subsequent Therapy (TFST)
大体时间:Up to approximately 3 years
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Up to approximately 3 years
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Cancer Antigen 125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
大体时间:Up to approximately 3 years
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Up to approximately 3 years
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Overall Change from Baseline in Global Health Status (GHS)/Quality of Life (QoL) Score Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
大体时间:Baseline up to approximately 3 years
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Baseline up to approximately 3 years
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Time to Deterioration (TTD) in the GHS/QoL Score Using the EORTC QLQ C30 Questionnaire
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
合作者和调查者
赞助
调查人员
- 研究主任:Study Official、Genmab
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GCT1184-07
- 2025 (美国 NIH 拨款/合同:Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- GOG-3143 (其他标识符:Other Identifier)
- ENGOT-ov103 (其他标识符:Other Identifier)
- GEICO-177-O (其他标识符:Other Identifier)
- APGOT-ov21 (其他标识符:Other Identifier)
- LACOG 0126-EVA (其他标识符:Other Identifier)
- 2025-524202-15-00 (克蒂斯)
- jRCT2021260025 (注册表标识符:Japan Registry for Clinical Trials (jRCT))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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