EUCTR2015-001633-24-DK进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1, 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.
- •2, Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined as meeting 1 of the following criteria: • Creatinine clearance <60 mL/min calculated by Cockcroft-GAult equation (using actual body weight) or by measured 24h urine collection• Common Terminology Criteria for Adverse Events (CTCAE) Grade =2 audiometric hearing loss • CTCAE Grade 2 peripheral neuropathy • New York Heart Association Class III heart failure.
- •3, Tumor PD-L1 status, with IHC assay confirmed by a reference laboratory, must be known prior to randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 820
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 365
排除标准
- •1, Prior exposure to immune-mediated therapy, 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.2, History of allogenic organ transplantation that requires use of immunosuppressive agents. 3, Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion: • Patients with vitiligo or alopecia • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement •Any chronic skin condition that does not require systemic therapy •Patients w/o active disease in the last 3 years may be included but only after prior consultation w/ AstraZeneca •Patients w/ celiac disease controlled by diet alone may be included but only after prior consultation w/ AstraZeneca but only after prior consultation w/ AstraZeneca. 4, Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids for at least 14 days prior to the start of study treatment. Patients with suspected or known brain metastases at screening should have an MRI(preferred)/CT, preferably with IV contrast to access baseline disease status.
- •5, Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- •6, Current or prior use of immunosuppressive medication within 14 days before the first dose of MEDI4736 or tremelimumab. The following are exceptions to this criterion: • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection), • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent, • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
- •7, Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IP.
研究者
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