jRCT2031250064尚未招募不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 530
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Female
入选标准
- •Patients must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- •Patients must have received 1 to 4 prior lines of therapy.
- •Patients must have received prior treatment with the following therapies:
- •-Platinum chemotherapy
- •-Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless the patient has a documented contraindication or due to precautions/intolerance
- •-Patients with known or suspected deleterious germline or somatic 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 patient is not eligible for treatment with PARP inhibitor
- •-Mirvetuximab soravtansine, if:
- •Mirvetuximab soravtansine is available in the enrollment region, and
- •The patient is eligible based on positive FRalpha expression per an FDA-approved (or local equivalent) test, and
- •The patient 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
- •Patients must have platinum-resistant disease:
- •-Patients who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, and must have either had a response (CR or PR) or had non-measurable disease at the start of platinum-based therapy, and then progressed between > 91 days and <= 183 days after the date of the last dose of platinum.
- •-Patients who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.
排除标准
- •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, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
- •Known active central nervous system metastases or carcinomatous meningitis. Patients 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. Patients with suspected brain metastases at screening should undergo a 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 patients who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
- •Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management. Enrollment of patients with an indwelling peritoneal catheter must be discussed with the medical monitor to determine eligibility.
结局指标
主要结局
-
PFS per Response Criteria in Solid Tumors (RECIST) v1.1, as determined by investigator assessment
次要结局
- Objective response rate (ORR)
- Duration of response
- CA-125 response
- Electrocardiogram (ECG) findings
研究者
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