NCT04131634终止2 期
A Phase II Trial of Stereotactic Ablative Radiation (SAbR) for Urothelial Cancer Patients With Progression While on Anti-PD-1/PD-L1 Immunotherapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS) at 6 months
研究概览
简要总结
To evaluate the benefit of SAbR for oligo-progressive metastatic urothelial cancer.
详细描述
Oligo-progressive urothelial cancer with limited disease burden and progression on an anti-PD-1/L1 immune checkpoint inhibitor.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be at least 18-years-old
- •ECOG performance status 0-2
- •Patients must have pathology-proven metastatic urothelial carcinoma, with tissue sampling of at least the primary tumor. Tissue sampling of each presumed metastatic site is not necessary, provided that the patient already has a confirmed diagnosis of urothelial cancer.
- •Patients must be on immune checkpoint inhibitor therapy with radiographic scans to verify oligo-progression of at least one and ≤ 6 sites of disease per RECIST 1.
- •Any of the currently FDA-approved PD-1/PD-L1 inhibitors are allowed. These include pembrolizumab, nivolumab, atezolizumab, avelumab, and durvalumab.
- •At least 1 metastatic lesion must show stable disease, partial response or complete response per RECIST 1.
- •Patients must be able to understand and willing to sign written informed consent.
- •Patients must have acceptable tolerability of ongoing therapy as decided by the treating medical oncologist.
- •Patients must have a desire to continue ongoing therapy.
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
排除标准
- •Inability to receive further immune checkpoint inhibitor therapy
- •Anticipated survival of fewer than 12 weeks
- •Daily steroid requirement of > 10 mg prednisone or prednisone-equivalent. Steroid replacement therapy for adrenal insufficiency is permitted.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
- •Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
研究组 & 干预措施
SAbR 6 measurable lesions
Experimental
PD-L1 assessment on biopsy of metastatic site (biopsy will be performed if no prior metastasis sample available)
干预措施: Stereotactic Ablative Radiation (Radiation)
结局指标
主要结局
Progression free survival (PFS) at 6 months
时间窗: 6 months
Progression free survival (PFS) at 6 months in the patients for whom SAbR is added to the ICI after progression on ICI. PFS will be defined as the combination of progressive disease from SAbR start date and death from any cause.
次要结局
- The disease control rate(6 months)
- The time to next-line systemic therapy(6 months)
- Overall survival of patients(6 months)
研究者
Aurelie Garant
Associate Professor of Medicine
University of Texas Southwestern Medical Center
研究点 (1)
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