EUCTR2016-000250-35-SI进行中（未招募）1 期
A Phase III, multicenter, randomized, placebo-controlled study of atezolizumab (anti-PD-L1 antibody) as monotherapy and in combination with platinum-based chemotherapy in patients with untreated locally advanced or metastatic urothelial carcinoma
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,213
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
- •- Age >= 18 years
- •- Considered to be eligible to receive platinum-based chemotherapy, in the investigator’s judgment
- •- Eastern Cooperative Oncology Group performance status of <= 2
- •- Histologically documented, locally advanced (T [tumor] 4b, any N [nodes]; or any T, N 2-3) or metastatic urothelial carcinoma (mUC) (M [metastasized] 1, Stage IV)
- •- Representative formalin-fixed paraffin-embedded tumor specimens in paraffin blocks or at least 15 unstained slides
- •- No prior chemotherapy for inoperable locally advanced or mUC
- •- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •- Adequate hematologic and end-organ function
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of carboplatin, cisplatin, or gemcitabine or for 5 months after the last dose of Atez
- •- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm that together result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of carboplatin and or gemcitabine, and/or cisplatin
- •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 468
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 732
排除标准
- •Cancer-Specific Exclusions:
- •- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
- •- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
- •- Active or untreated central nervous system metastases as determined by computed tomography or magnetic resonance imaging evaluation during screening and prior radiographic assessments
- •- Leptomeningeal disease
- •- Uncontrolled hypercalcemia, tumor-related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •- Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1
- •General Medical Exclusions:
- •- Life expectancy of < 12 weeks
- •- Pregnant or lactating, or intending to become pregnant during the study
- •- Serum albumin < 25 gram per liter
- •Exclusion Criteria Related to Atez:
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •- History of autoimmune disease
- •- Patients with prior allogeneic stem cell or solid organ transplantation
- •- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis
- •- Significant cardiovascular disease
- •- Known left ventricular ejection fraction < 40%
- •- Positive test for HIV
- •- Active hepatitis B or hepatitis C, tuberculosis
- •- Severe infections within 4 weeks prior to randomization
- •- Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization
- •- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
- •- Prior treatment with Cluster of Differentiation (CD) 137 agonists, anti- cytotoxic T-lymphocyte-associated protein (CTLA)-4, anti- programmed cell death protein (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
- •- Treatment with systemic immunostimulatory agents, systemic corticosteroids or other systemic immunosuppressive medications
- •Exclusion Criteria Related to Gemcitabine:
- •- Known hypersensitivity to gemcitabine
- •Exclusion Criteria Related to Carboplatin:
- •- History of severe allergic reactions to cisplatin or other platinum-containing compounds
- •- Severe bone marrow depression or significant bleeding
- •Exclusion Criteria Related to Cisplatin:
- •- Patients with preexisting renal impairment
- •- Patients with myelosuppresion or hearing impairment
- •- History of allergic reactions to cisplatin or other platinum-containing compounds
研究者
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