An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China (RAINFOL-02)
2026年9月7日 更新者：Genmab
A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer
The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.
Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.
All participants will receive active drug; no one will be given placebo.
This study is an extension study of the protocol GCT1184-02 (NCT06619236).
研究概览
研究类型
介入性
注册 (估计的)
82
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
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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Changchun、中国
- 招聘中
- The First Hospital of Jilin University
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Changsha、中国
- 招聘中
- Hunan Cancer Hospital
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Chengdu、中国
- 招聘中
- West China Second University Hospital, Sichuan University
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Chongqing、中国
- 招聘中
- Chongqing University Cancer Hospital - Chongqing Cancer Hospital
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Guangzhou、中国
- 招聘中
- Sun Yat-sen University Cancer Center
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Guangzhou、中国
- 招聘中
- Sun Yat-sen Memorial Hospital
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Hangzhou、中国
- 招聘中
- Zhejiang Cancer Hospital
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Harbin、中国
- 招聘中
- Harbin Medical University Cancer Hospital
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Jinan、中国
- 招聘中
- Shandong First Medical University Affiliated Tumor Hospital
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Nanjing、中国
- 招聘中
- Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
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Shanghai、中国
- 招聘中
- Obstetrics & Gynecology Hospital of Fudan University
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Shanghai、中国
- 招聘中
- Fudan University Shanghai Cancer Hospital
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Shenyang、中国
- 招聘中
- Liaoning Cancer Hospital
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Taiyuan、中国
- 招聘中
- Shanxi Cancer Hospital
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Tianjin、中国
- 招聘中
- Tianjin Medical University Cancer Institute & Hospital
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Xi'an、中国
- 招聘中
- The First Affiliated Hospital of Xi'an Jiaotong University
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Zhengzhou、中国
- 招聘中
- Henan Cancer Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Key Inclusion Criteria:
- Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- Participants may be enrolled regardless of FRα expression level.
- Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
Participants must have received prior treatment with the following therapies:
- Platinum chemotherapy
- Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
- Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor
Mirvetuximab soravtansine, if:
- Mirvetuximab soravtansine is available in the enrollment region, and
- The participant is eligible, and
- The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
Participants must have platinum-resistant disease:
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between > 91 days and ≤ 183 days after the date of the last dose of platinum.
- Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.
Key Exclusion Criteria:
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
- History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
- Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
- Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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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有源比较器：研究者的选择
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静脉输液
静脉输液
静脉输液
静脉输液
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实验性的：丽娜-S
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静脉 (IV) 输注
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 |
|---|---|---|
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Progression-Free Survival (PFS)
大体时间：Up to approximately 16 months
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.
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Up to approximately 16 months
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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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Overall Survival (OS)
大体时间：Up to approximately 25 months
|
OS is defined as the time from date of randomization to date of death due to any cause.
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Up to approximately 25 months
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Objective Response Rate (ORR)
大体时间：Up to approximately 25 months
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ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.
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Up to approximately 25 months
|
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PFS as Determined by BICR
大体时间：Up to approximately 16 months
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR.
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Up to approximately 16 months
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ORR as Determined by BICR
大体时间：Up to approximately 25 months
|
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.
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Up to approximately 25 months
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Duration of Response (DOR)
大体时间：Up to approximately 25 months
|
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR).
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Up to approximately 25 months
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Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
大体时间：Up to approximately 25 months
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A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.
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Up to approximately 25 months
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Time to Second Disease Progression or Death From any Cause (PFS2)
大体时间：Up to approximately 25 months
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PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.
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Up to approximately 25 months
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Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)
大体时间：Baseline, up to approximately 25 months
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Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire.
The score ranges from 0 to 100.
A high scale score represents a higher response level.
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Baseline, up to approximately 25 months
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Time to Deterioration (TTD) in the GHS/Qol Score
大体时间：Up to approximately 25 months
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TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score.
A longer TTD indicates a better outcome.
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Up to approximately 25 months
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
大体时间：Up to approximately 25 months
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Up to approximately 25 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Study Official、Genmab
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月26日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年5月18日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年9月1日
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
- GCT1184-02 Extension Study
- CTR20253987 (注册表标识符：ChinaDrugTrials.org.cn)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.