NCT06317311进行中（未招募）2 期
A Phase 2, Multicenter, Open-label, Single Arm Study of Dostarlimab Plus Carboplatin-paclitaxel Followed by Dostarlimab Monotherapy in Japanese Patients With Primary Advanced or Recurrent Endometrial Cancer (RUBY-J)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR)
研究概览
简要总结
The goal of this clinical trial is to understand the effectiveness of dostarlimab and carboplatin-paclitaxel followed by dostarlimab monotherapy in participants with endometrial cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Participant has histologically or cytologically proven endometrial cancer with recurrent or advanced disease.
- •Participant has molecular subtype of defective mismatch repair/microsatellite instability high (dMMR/MSI-H) or mismatch repair proficient/microsatellite stable (MMRp/MSS) determined.
- •Participant must have primary Stage III or Stage IV disease or first recurrent endometrial cancer with a low potential for cure by radiation therapy or surgery alone or in combination, and presence of at least one measurable lesion per RECIST 1.1 based on Investigator's assessment.
- •Participant is not pregnant or breastfeeding and agrees to use a highly effective contraceptive method during the study period if a woman of childbearing potential (WOCBP).
- •Participant has an Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0 or
- •Participant has adequate organ function, as assessed by hematologic, renal, hepatic and coagulation parameters.
排除标准
- •Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for <3 years or who received any active treatment in the last 3 years for that malignancy. Non-melanoma skin cancer is allowed.
- •Participant has any medical history of interstitial lung disease or pneumonitis.
- •Participant has cirrhosis or current unstable liver or biliary disease.
- •Participant has known uncontrolled central nervous system metastases, carcinomatosis meningitis, or both.
- •Participant has a diagnosis of immunodeficiency.
- •Participant has received prior therapy with an anti- Programmed death protein 1 (PD-1), anti- Programmed death ligand 1 (PD-L1), anti- Programmed death ligand 2 (PD-L2), or anti- Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent.
- •Participant has not recovered adequately from AEs.
- •Participant has received prior anticancer therapy (chemotherapy, targeted therapies, hormonal therapy, radiotherapy, or immunotherapy) within 21 days or <5 times the half-life of the most recent therapy prior to the first dose of study intervention, whichever is shorter.
- •Participant has received any live vaccine within 30 days of the first dose of study intervention. Vaccination against coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms are not exclusionary.
- •Participant has HBsAg positive, or HCV RNA positive.
- •Participant is known HIV infection.
- •Participant is currently participating and receiving study intervention or has participated in a study of an investigational agent and received study intervention or used an investigational device within 4 weeks of the first dose of treatment.
- •Participant with contraindication to carboplatin and paclitaxel.
研究组 & 干预措施
Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy
Experimental
干预措施: Dostarlimab (Biological)
Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy
Experimental
干预措施: Carboplatin (Drug)
Dostarlimab- Carboplatin-Paclitaxel followed by Dostarlimab Monotherapy
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR)
时间窗: Approximately 18 months
DRR12 is defined as the proportion of participants with Complete Response (CR) or Partial Response (PR) lasting greater than or equal to (≥) 12 months, per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
次要结局
- DRR12 per RECIST 1.1, assessed by investigator(Approximately 18 months)
- Progression-free survival (PFS) per RECIST 1.1, assessed by BICR and investigator(Up to approximately 3 years)
- DCR per RECIST 1.1 assessed by investigator(Up to approximately 3 years)
- Disease control rate (DCR) per RECIST 1.1 assessed by BICR(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 3 years)
- Overall response rate (ORR) per RECIST 1.1 assessed by BICR(Up to approximately 3 years)
- ORR per RECIST 1.1 assessed by investigator(Up to approximately 3 years)
- Duration of response (DOR) per RECIST 1.1 assessed by BICR(Up to approximately 3 years)
- DOR per RECIST 1.1 assessed by investigator(Up to approximately 3 years)
- Maximum concentration (Cmax) for dostarlimab(Up to 67 weeks)
- Minimum concentration (Cmin) for dostarlimab(Up to 67 weeks)
- Number of participants with adverse events (AEs), Immune-related adverse events (irAEs), and serious adverse events (SAEs) by severity(Up to approximately 3 years)
- Number of participants AEs, irAEs, and SAEs leading to dose modifications such as dose delay or study intervention discontinuation(Up to approximately 3 years)
- Number of participants with AEs leading to death(Up to approximately 3 years)
研究者
研究点 (1)
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