CTIS2023-506551-23-00进行中（未招募）1 期
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY OF DOSTARLIMAB (TSR-042) PLUS CARBOPLATIN-PACLITAXEL VERSUS PLACEBO PLUS CARBOPLATIN-PACLITAXEL IN PATIENTS WITH RECURRENT OR PRIMARY ADVANCED ENDOMETRIAL CANCER (RUBY) - 4010-03-001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Tesaro Inc.
- 入组人数
- 785
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
入选标准
- •(Part 1 and Part 2): 1. Female subject at least 18 years of age, who is able to understand the study procedures and agrees to participate in the study by providing written informed consent., (Part 1 and Part 2): 2. Subject has histologically or cytologically proven endometrial cancer with recurrent or advanced disease., (Part 1 and Part 2): 3. Subject must provide adequate tumor tissue sample at Screening for MMR/MSI status testing. Note: The quality of the tumor tissue sample must be confirmed by the central laboratory during screening. Subjects should not be randomized without central laboratory confirmation., (Part 1 and Part 2): 4. Subject 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 meet at least 1 of the following criteria: a) Subject has primary Stage IIIA to IIIC1 disease with presence of evaluable or measurable disease per RECIST v.1.1 based on Investigator’s assessment. Lesions that are equivocal or can be representative of post-operative change should be biopsied and confirmed for the presence of tumor. b) Subject has primary Stage IIIC1 disease with carcinosarcoma, clear cell, serous, or mixed histology (containing =10% carcinosarcoma, clear cell, or serous histology) regardless of presence of evaluable or measurable disease on imaging. c) Subject has primary Stage IIIC2 or Stage IV disease regardless of presence of evaluable or measurable disease. d) Subject has first recurrent disease and is naïve to systemic anticancer therapy. e) Subject has received prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence or PD = 6 months after completing treatment (first recurrence). Note: Subjects with uterine sarcoma are not allowed., (Part 1 and Part 2): 5. Subject has an ECOG performance status of 0 or 1., (Part 1 and Part 2): 6. Subject has adequate organ function, defined as follows: a) Absolute neutrophil count =1,500 cells/µL b) Platelets =100,000 cells/µL c) Hemoglobin =9 g/dL or =5.6 mmol/L d) Serum creatinine =1.5× upper limit of normal (ULN) or calculated creatinine clearance =50 mL/min using the Cockcroft-Gault equation for subjects with creatinine levels >1.5 × institutional ULN e) Total bilirubin =1.5× ULN and direct bilirubin =1× ULN f) Aspartate aminotransferase and alanine aminotransferase =2.5× ULN unless liver metastases are present, in which case they must be =5× ULN g) International normalized ratio or prothrombin time (PT) =1.5× ULN and activated partial thromboplastin time =1.5× ULN. Subjects receiving anticoagulant therapy must have a PT or partial thromboplastin within the therapeutic range of the intended use of anticoagulants., (Part 1 and Part 2): 7. Contraceptive use by subjects should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a) A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • The participant is a woman of nonchildbearing potential. OR • The participant is a WOCBP, using a contraceptive method that is highly effective (with a failure rate of <1% per year and, preferably, with low user dependency) during the Treatment Period and for at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova or oocytes) for the purpose of reproduction during this period.
排除标准
- •(Part 1 and Part 2) 1.Subject has received neo-adjuvant/adjuvant systemic anticancer therapy for primary Stage III or IV disease and: a. has not had a recurrence or PD prior to first dose on the study OR b. has had a recurrence or PD within 6 months of completing anticancer therapy treatment prior to first dose on the study Note: Low-dose cisplatin given as a radiation sensitizer or hormonal therapies do not exclude subjects from study participation., (Part 1 and Part 2) 10.Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of systemic immunosuppressive therapy within 7 days prior to the first dose of study treatment., (Part 1 and Part 2) 11.Subject has not recovered (ie, to Grade =1 or to baseline) from cytotoxic therapy-induced AEs or has received transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within 21 days prior to the first dose of study drug. Note: Subjects with Grade =2 neuropathy, Grade =2 alopecia, or Grade =2 fatigue are an exception to this criterion and may qualify for the study., (Part 1 and Part 2) 12. Subject has not recovered adequately from AEs or complications from any major surgery prior to starting therapy., (Part 1 and Part 2) 13. Subject has a known hypersensitivity to carboplatin, paclitaxel, or dostarlimab components or excipients., (Part 1 and Part 2) 14.Subject is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment., (Part 1 and Part 2) 15.Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, noninfectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent)., (Part 1 and Part 2) 16.Subject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment., (Part 1 and Part 2) 17.Subject has received, or is scheduled to receive, a live vaccine within 30 days before first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment., Part 2 only: 18.Subject has received prior therapy with a PARP inhibitor., Part 2 only: 19.Subject has clinically significant cardiovascular disease (eg, significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina <6 months to enrollment, New York Heart Association Grade =2 congestive heart failure, serious cardiac arrhythmia requiring medication, Grade =2 peripheral vascular disease, and history of cerebrovascular accident within 6 months)., (Part 1 and Part 2) 2.Subject has had >1 recurr
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