EUCTR2015-001633-24-IT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 - DANUBE
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
- 性别
- All
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 24-hour 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 without active disease
- •in the last 3 years may be included but only after consultation with
- •AstraZeneca • Patients with celiac disease controlled by diet alone may
- •be included but only after consultation with 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 investigational product (IP). 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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