2024-510865-41-00招募中4 期
Treatment Of Metastatic Bladder cancer at the time Of biochemical reLApse following radical cystectomy - TOMBOLA
Aarhus Universitetshospital4 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2024年6月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 282
- 试验地点
- 4
- 主要终点
- Complete response (CR) after treatment with investigational agent initiated by ctDNA positive status after radical cystectomy (with or without concomitant visible metastases on CT)
研究概览
简要总结
Complete response (CR) after treatment with investigational agent initiated by ctDNA positive statusafter radical cystectomy (with or without concomitant visible metastases on CT). Data will becompared to available historical data on response to PD-1 / PD-L1 targeted agents14,15. CR in thecurrent study is defined as ctDNA negative status in the last plasma samples taken during IOtreatment combined with negative imaging (CT) at the same time point after treatment. Thus, anymetastasis visible on CT at the time of treatment initiation should undergo complete response. InStudy Subjects without visible metastasis on CT at the time of treatment, initiation should result inunchanged status on CT.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Tombola
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age at the time of signing the Informed Consent Form
- •For male Study Subjects: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
- •Signed Informed Consent Form
- •ECOG PS 0 or 1
- •Is, according to the Investigator’s judgement, able to comply with the trial protocol
- •Ability to understand the Participant Information Sheet orally and in writing
- •Preoperative PET/CT of thorax, abdomen, and pelvis with no suspicion of organ metastases or lymph node metastasis* above the aortic bifurcation
- •Study Subjects planned to undergo radical cystectomy due to histopathological or clinical documented muscle invasive urothelial carcinoma (including subtypes) stage cT2-4a in the urinary bladder following NAC** in cisplatin-fit Study Subjects
排除标准
- •Other histology of BC than urothelial carcinoma – mixed tumours with urothelial features are allowed
- •Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without metastasis
- •Known contraindication to immunotherapy
- •A history of autoimmune disease. Study Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
- •Study Subjects who meet any of the following criteria will be excluded from study entry: o History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan o Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
- •HIV positive
- •History of pneumonitis (History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •Hepatitis B or hepatitis C infection
- •Subjects who have received a live, attenuated vaccine within 28 days prior to enrolment
结局指标
主要结局
Complete response (CR) after treatment with investigational agent initiated by ctDNA positive status after radical cystectomy (with or without concomitant visible metastases on CT)
Complete response (CR) after treatment with investigational agent initiated by ctDNA positive status after radical cystectomy (with or without concomitant visible metastases on CT)
次要结局
未报告次要终点
研究者
Jørgen Bjerggaard Jensen
Scientific
Aarhus Universitetshospital
研究点 (4)
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