EUCTR2017-002979-26-ES进行中（未招募）1 期
A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non Muscle Invasive Bladder Cancer Patients (POTOMAC) - POTOMAC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 975
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
- •-BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible).
- •-Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high risk tumor is defined as one of the following:
- •?High grade/G3 tumor
- •?Multiple and recurrent and large (with diameter of largest evaluable node =3 cm) tumors (all conditions must be met in this point)
- •-Complete resection (or as complete as possible) of all Ta/T1 papillary disease prior to randomization, with the most recent TURBT occurring 2 months or less prior to signing informed consent for this study. Patients with residual CIS after TURBT are eligible.
- •-No prior radiotherapy to the bladder.
- •-No prior exposure to immune-mediated therapy of cancer including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies. Patients who have been treated with anticancer vaccines will be excluded.
- •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 292
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 683
排除标准
- •-Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV).
- •-Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium.
- •-Previous investigational product (IP) assignment in the present study.
- •-Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer related conditions (eg, hormone replacement therapy) is acceptable.
- •-Active infection including TB (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (HIV [positive HIV] 1/2) antibodies. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
- •-Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. 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, computed tomography [CT] scan premedication)
- •-15.Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
- •-History of another primary malignancy
研究者
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