EUCTR2019-001310-42-ES进行中（未招募）1 期
A randomized phase II trial assessing trimodality therapy with or without adjuvant Durvalumab (MEDI4736) to treat patients with muscle-invasive bladder cáncer
Canadian Cancer Trials Group (CCTG)0 个研究点目标入组 238 人开始时间: 2019年7月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 238
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. Histologic diagnosis of urothelial carcinoma of the bladder
- •2. Stage T2-T4a N0M0 at time of diagnosis (AJCC-TNM version 8
- •3. CT scan of the chest/abdomen/pelvis within 8 weeks from enrollment, showing no evidence of metastatic disease
- •4. Patients must be = 18 years of age
- •5. Patients must have a life expectancy greater than 6 months
- •6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix I) and a body weight of > 30kg
- •7. Patients must have adequate hematologic reserve
- •8. Patients must have an estimated creatinine clearance = 30 ml/min
- •9. Patients must have adequate liver function
- •10. All patients must have a tumour block from their primary tumour available and consent to release for correlative analyses
- •11. Patients have completed prior trimodality therapy (TMT) consisting of surgery, chemotherapy and radiation therapy treatment prior to enrollment on the BL.13 study
- •Patients should begin protocol treatment within 42 days after completion of TMT
- •12. Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires
- •13. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements
- •14. Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
- •15. In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment
- •16. Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 3 months following treatment.
- •Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation
- •17. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 138
排除标准
- •1. Pre-existing medical conditions precluding treatment
- •2. Pregnancy or lactating mothers
- •3. Received prior therapy with anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137, anti-CTLA-4) antibody
- •4. Active or prior documented autoimmune or inflammatory disorders, diverticulitis with the exception of diverticulosis, celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener síndrome, rheumatoid arthritis, hypophysitis, uveitis, etc., within the past 3 years prior to the start of treatment.
- •5. Patients with active or uncontrolled intercurrent illness including, but not limited to:
- •cardiac dysfunction
- •active peptic ulcer disease or gastritis
- •active bleeding diatheses
- •psychiatric illness
- •Tuberculosis
- •HIV virus infection
- •known active hepatitis B infection
- •known active hepatitis C infection
- •6. History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe immune mediated toxicity from other immune therapy or grade = 3 infusion reaction
- •7. Current or prior use of immunosuppressive medication within 28 days of study entry
- •8. Peripheral neuropathy = grade 2
- •9. History of allergic or hypersensitivity reactions to any study drug or their excipients
- •10. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) = 470 msec in screening ECG or history of familial long QT syndrome
- •11. History of interstitial lung disease
- •12. Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy
- •13. Any condition that does not permit compliance with the protocol
- •14. Live attenuated vaccination administered within 30 days prior to randomization.
研究者
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