NCT05751629已完成2 期
Cohort A: PARP Inhibitor-Naïve Platinum-Resistant Ovarian Cancer Treatment Cohort With TSR-042, Bevacizumab, and Niraparib
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Tesaro, Inc.
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Confirmed Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment
研究概览
简要总结
The primary objective of this sub study is to evaluate the efficacy of the combination of TSR-042, bevacizumab, and niraparib in participants with advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 2 prior lines of anticancer therapy, are PARP inhibitor naïve, and have platinum-resistant but not refractory disease.
This study is a sub study of the master protocol - OPAL (NCT03574779).
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 must be resistant to the most recent platinum-based therapy, defined for the purpose of this protocol as progression within 6 months from completion of a minimum of 4 cycles of platinum-containing therapy. This should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing disease progression. Participant with primary platinum-refractory disease as defined by those who progressed during or within 4 weeks of completion of first platinum-based chemotherapy are not eligible
- •Participant must not have received any prior therapy for ovarian cancer with a PARP inhibitor
- •Participant has had 1 to 2 prior lines of anticancer therapy for ovarian cancer
- •Participant is able to take oral medications.
排除标准
- •Participant has known hypersensitivity to TSR-042, bevacizumab, niraparib, their components, or their excipients
- •Participant has a known history of myelodysplastic syndrome or acute myeloid leukemia
- •Participant has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- •Participant received prior treatment with an anti- programmed death-1 (PD-1) or anti- programmed death-ligand 1 (PD-L1) agent
- •Participant has received prior treatment with anti-angiogenic therapy with the exception of bevacizumab. (Participant who received prior bevacizumab are eligible only if they did not discontinue bevacizumab due to toxicity, as established by the Investigator.)
- •Participant has bowel obstruction, had bowel obstruction within the past 3 months, or is otherwise judged by the Investigator to be at high risk for bowel obstruction related to the underlying disease. Participant has any history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscesses. Evidence of recto-sigmoid involvement by pelvic examination or significant bowel involvement on computed tomography scan
- •Participant has proteinuria as demonstrated by urine protein:creatinine ratio ≥1.0 at screening or urine dipstick for proteinuria ≥2 (Participant discovered to have ≥2 proteinuria on dipstick at baseline should undergo 24-hour urine collection and must demonstrate <2g of protein in 24 hours to be eligible.)
- •Participant is at increased bleeding risk due to concurrent conditions (eg, major injuries or surgery within the past 28 days prior to start of study treatment, history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months)
- •Participant has a history of recent major thromboembolic event defined as follows:
- •Pulmonary embolism diagnosed within 3 months of enrollment
- •Lower extremity deep venous thrombosis diagnosed within 3 months of enrollment (Participant with a history of thromboembolic disease on stable therapeutic anticoagulation for more than 3 months prior to enrollment are eligible for this study.)
研究组 & 干预措施
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Experimental
干预措施: Dostarlimab (Drug)
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Experimental
干预措施: Bevacizumab (Drug)
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Experimental
干预措施: Niraparib (Drug)
结局指标
主要结局
Confirmed Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment
时间窗: Up to approximately 38 Months
ORR was defined as percentage of participants with a confirmed investigator-assessed Best Overall Response (BOR) of confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).
次要结局
- Progression Free Survival (PFS) Per RECIST Version 1.1 by Investigator Assessment(Up to approximately 38 Months)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to approximately 38 Months)
- Change From Baseline in Vital Signs (Weight) at End of Treatment(Baseline (Day 1) and end of treatment (Up to approximately 32 months))
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters - Chemistry, Coagulation, Hematology and Thyroid(Up to approximately 38 Months)
- Absolute Values in Urinalysis Parameter - Specific Gravity (Ratio)(Baseline (Day 1) and end of treatment (Up to approximately 32 months))
- Overall Survival (OS)(Up to approximately 38 Months)
- Disease Control Rate (DCR) Per RECIST Version 1.1 by Investigator Assessment(Up to approximately 38 Months)
- Duration of Response (DOR) Per RECIST Version 1.1 by Investigator Assessment(Up to approximately 38 Months)
- Change From Baseline in Cancer Antigen 125 (CA-125) at End of Treatment(Baseline (Day 1) and end of treatment (Up to approximately 32 months))
- Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment(Baseline (Day 1) and end of treatment (Up to approximately 32 months))
研究者
研究点 (1)
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