2024-511316-25-00招募中1 期
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients with Urothelial Carcinoma (MORPHEUS-UC)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 13
- 主要终点
- 1. Objective response rate (mUC Cohort)
研究概览
简要总结
Metastatic urothelial carcinoma cohort (mUC) cohort: To evaluate the efficacy of immunotherapy-based treatment combinations during Stage 1 based on Objective response rate MIBC cohorts: To evaluate the efficacy of treatment in patients treated perioperatively for MIBC based on pathologic complete response
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase Ib/II, open-label, randomized, immunotherapy-based treatments, urothelial carcinoma
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Stage 1: Availability of a representative tumor specimen that is suitable for determination of Programmed death-ligand 1 (PD-L1) and/or additional biomarker status by means of central testing
- •Stage 1: Disease progression during or following treatment with no more than one platinum containing regimen for inoperable, locally advanced or metastatic UC or disease recurrence
- •Stage 1 and Stage 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST) v1.1
- •Stage 1 and Stage 2 Negative HIV test at screening
- •For the Muscle Invasive Bladder Cancer Cohorts (MIBC) Availability of a TURBT specimen that is suitable for determination of PD-L1 and additional biomarker status by means of central testing
- •For the Muscle Invasive Bladder Cancer Cohorts (MIBC) N0 or M0 disease assessed by CT or magnetic resonance imaging (MRI) scan (within 4 weeks of study treatment initiation)
排除标准
- •For mUC cohort: Stage 1 Prior treatment with a T-cell co-stimulating therapy or an immune checkpoint inhibitor, or investigational therapy within 28 days before C1D1, or any approved anti-cancer therapy within 3 weeks before study
- •For mUC cohort: Stage 1 and Stage 2 Prior systemic immunostimulatory treatments within 4 weeks or 5 half-lives of the drug before study, or with systemic immunosuppressants within 2 weeks before study, or need such during study
- •For mUC cohort: Stage 1 and Stage 2 History of leptomeningeal disease, autoimmune disease, idiopathic pulmonary fibrosis (IPF), organizing pneumonia drug-induced pneumonitis, or idiopathic pneumonitis, or active pneumonitis at screening
- •For mUC cohort: Stage 1 and Stage 2 Active tuberculosis (TB)
- •For MIBC Cohorts Received a live, attenuated vaccine within 4 weeks before study, or needing such during atezolizumab treatment or within 5 months after the last dose
- •For MIBC Cohorts Active or history of autoimmune disease or immune deficiency
结局指标
主要结局
1. Objective response rate (mUC Cohort)
1. Objective response rate (mUC Cohort)
2. Pathological complete response (MIBC Cohorts)
2. Pathological complete response (MIBC Cohorts)
次要结局
- 1. Progression-free survival
- 2. Overall survival after randomization
- 3. Overall survival rate at specific time points
- 4. Duration of response
- 5. Disease control
- 6. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0
- 7. Change from baseline in vital signs
- 8. Change from baseline in targeted clinical laboratory test results MIBC Cohorts
- 9. Landmark recurrence-free survival, event-free survival and overall survival MIBC Cohorts
- 10. Incidence, nature, and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v4.0
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (13)
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