jRCT2061230114招募中不适用
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) (RUBY-J)
GlaxoSmithKline K.K.0 个研究点目标入组 36 人开始时间: 2024年5月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 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
- Single Arm Study
- 干预模型
- Single 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
- •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.
结局指标
主要结局
-
Durable response rate for 12 months (DRR12) assessed by Blinded independent central review (BICR)
次要结局
- DRR12 per RECIST 1.1
- Progression-free survival (PFS) per RECIST 1.1
- OS
- Overall response rate (ORR) per RECIST 1.1
- Disease control rate (DCR) per RECIST 1.1
- Duration of response (DOR) per RECIST 1.1
研究者
相似试验
进行中（未招募）
2 期
Dostarlimab and Cobolimab in Advanced Cervical CancerAdvanced Cervical CarcinomaMetastatic Cervical CancerMetastatic Cervical CarcinomaRecurrent Cervical CarcinomaCervical CancerNCT06238635Meghan Shea66
进行中（未招募）
2 期
Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix CancerRecurrent Cervix CancerProgressive Cervix CancerNCT04068753University of Oklahoma66
招募中
2 期
Study of the Combination Dostarlimab With Niraparib In Patients With Penile CarcinomaPenile CarcinomaNCT05526989H. Lee Moffitt Cancer Center and Research Institute25
招募中
不适用
A Phase 3 study of belrestotug plus dostarlimab compared with placebo plus pembrolizumab in previously untreated PD-L1 high NSCLC
(GALAXIES LUNG-301)jRCT2051240051GlaxoSmithKline K.K.1,000
进行中（未招募）
3 期
A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial CancerNeoplasmsNCT03981796Tesaro, Inc.785