ACTRN12620000063910已完成1 期
A phase 1 open label dose-escalation study to evaluate the tolerability, safety, and immunological efficacy of sub-urothelial durvalumab injection in adult subjects with muscle invasive bladder cancer or high-risk non-muscle invasive bladder tumours.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Study population: Participants with either muscle invasive bladder cancer or high-risk non-muscle invasive (T1, high grade Ta, carcinoma in-situ) bladder tumours scheduled for cystectomy, who have refused or are ineligible for systemic neo-adjuvant chemotherapy.
- •Inclusion criteria;
- •1. Age equal to or greater than 18 years
- •2. ECOG performance less than 2
- •3. Life expectancy equal to or greater than 6 months
- •4. Adequate organ and marrow function
排除标准
- •1. Patients who have received neo-adjuvant chemotherapy
- •2. Any concurrent cancer therapy of the same biological intent that may interact with durvalumab.
- •3. Participation in another clinical study with an investigational product during the last 28 days
- •4. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade equal to or greater than 2 from previous anticancer therapy
- •5. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of sub-urothelial durvalumab
- •6. Major surgical procedure within 28 days prior to administration of durvalumab, excluding trans-urethral resection of bladder tumour
- •7. History of allogenic organ transplantation
- •8. Active or prior documented autoimmune or inflammatory disorders
- •9. History of another primary malignancy within the last 5 years, excluding non-melanomatous skin cancer
- •10. History of active primary immunodeficiency
- •11. Active tuberculosis, hepatitis B, hepatitis C
- •12. Current or prior use of immunosuppressive medication within 14 days before the first dose
- •of durvalumab
- •13. Receipt of live attenuated vaccine within 30 days prior to administration of sub-urothelial
- •durvalumab. Patients should not receive live vaccine up to 30 days after durvalumab
- •administration
- •14. Female patients who are pregnant or breastfeeding or male or female patients of
- •reproductive potential who are not willing to employ effective birth control from screening
- •to 90 days after the last dose of durvalumab
- •15. Known allergy or hypersensitivity to durvalumab
研究者
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