NL-OMON50230已完成3 期
A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Cancer - DANUBE
Astra Zeneca0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
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 99（—）
入选标准
- •1. Age *18 years at the time of screening.
- •2. Written informed consent
- •3. Patients with histologically or cytologically documented, unresectable,
- •Stage IV transitional
- •cell carcinoma of the urothelium who have not been previously treated with
- •first-line chemotherapy.
- •4. At least 1 lesion, not previously irradiated, that can be accurately
- •measured at
- •baseline as *10 mm in the longest diameter with a computed tomography (CT) or
- •magnetic resonance imaging (MRI) and that is suitable for accurate repeated
- •measurements as per
- •Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
- •guidelines.
- •5. Eastern Cooperative Oncology Group (ECOG) PS 0 or 1
- •6. Life expectancy *12 weeks (in the opinion of the Investigator)
- •7. Patients eligible or ineligible for cisplatin-based chemotherapy.
- •8. Tumor PD-L1 status, with IHC assay confirmed by a reference laboratory, must
- •known prior to randomization.
- •9. Adequate organ and marrow function
排除标准
- •1. Involvement in the planning and/or conduct of the study
- •2. Previous IP assignment in the present study
- •3. Concurrent enrollment in another clinical study, unless it is an
- •observational (noninterventional) clinical study or during the follow-up period
- •of an interventional study
- •4. Prior exposure to immune-mediated therapy (with exclusion of Bacillus
- •Calmette Guerin), including but not limited to, other anti-CTLA-4, anti-PD-1,
- •anti-PD-L1, or anti-PD-L2 antibodies, including therapeutic anticancer
- •vaccines. Prior local intervesical chemotherapy or immunotherapy is allowed if
- •completed at least 28 days prior to the initiation of study treatment
- •5. Any unresolved toxicity NCI CTCAE Grade *2 from previous anticancer therapy
- •with the exception of alopecia, vitiligo, and the laboratory values defined in
- •the inclusion criteria.
- •6. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
- •treatment. Concurrent use of hormonal therapy for non-cancer-related conditions
- •(eg, hormone replacement therapy) is acceptable.
- •7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide
- •field of radiation within 28 days of the first dose of study drug.
- •8. Major surgical procedure (as defined by the Investigator) within 28 days
- •prior to the first dose of IP.
- •9. History of allogenic organ transplantation that requires use of
- •immunosuppressive agents.
- •10. Active or prior documented autoimmune or inflammatory disorders
- •11. Uncontrolled intercurrent illnesses.
- •12. Other malignancy within 5 years before first dose of IP, except for the
- •following pending a discussion with AstraZeneca: Patients with a history of
- •prostate cancer and patients who have been adequately treated for a malignancy
- •with a low potential risk for recurrence.
- •13. History of leptomeningeal carcinomatosis
- •14. Brain metastases or spinal cord compression.
- •15. QT interval corrected for heart rate *470 ms calculated from 3 ECGs.
- •16. History of active primary immunodeficiency
- •17. Active infection, including tuberculosis, hepatitis B, hepatitis C, or
- •human immunodeficiency virus.
- •18. Current or prior use of immunosuppressive medication within 14 days before
- •first dose of IP.
- •19. Receipt of live attenuated vaccine within 30 days prior to the first dose
- •20. 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 MEDI4736
- •monotherapy or 180 days after the last dose of MEDI4736 + tremelimumab
- •combination therapy
- •21. Known allergy or hypersensitivity to IP or any IP excipient, or to other
- •humanized mAbs
- •22. Any medical contraindication to platinum (cisplatin or carboplatin)-based
- •doublet chemotherapy
- •23. Patient <30 kg in weight
研究者
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