EUCTR2014-005603-25-FR进行中（未招募）1 期
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) VERSUS OBSERVATION AS ADJUVANT THERAPY IN PATIENTS WITH PD-L1-SELECTED, HIGH RISK MUSCLE INVASIVE BLADDER CANCER AFTER CYSTECTOMY
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •- Histologically or cytologically confirmed muscle-invasive transitional cell carcinoma (TCC) (also termed urothelial carcinoma [UC]) of the bladder (excluding TCC of renal pelvis, ureters, or urethra)
- •- Tumor Nodes Metastasis (TNM) classification at pathological examination of cystectomy specimen - For patients treated with prior neoadjuvant chemotherapy: tumor stage of ypT2-T4a or ypN+; For patients not treated with prior neoadjuvant chemotherapy: tumor stage of pT3-T4a or pN+
- •- Cystectomy with lymph node dissection
- •- MIBC with a PD-L1 immunohistochemistry (IHC) score of IC2/3 prospectively determined on the cystectomy tumor specimens by a central laboratory
- •- Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 6 weeks prior to randomization
- •- Full recovery from cystectomy within 12 weeks following surgery
- •- Eastern Cooperative Oncology Group performance status score of <=2
- •- Life expectancy >=12 weeks
- •- Adequate hematologic and end-organ function
- •- For women who are not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined non-hormonal contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 90 days after the last dose of study drug
- •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 264
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 176
排除标准
- •- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- •- Adjuvant chemotherapy or radiation therapy for UC following cystectomy
- •- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- •- Malignancies other than MIBC within 5 years prior to Cycle 1, Day 1
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •- History of autoimmune disease
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •- Tested Positive for HIV
- •- Patients with active hepatitis B virus and tuberculosis
- •- Prior allogeneic stem cell or solid organ transplant
- •- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
- •- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
研究者
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