EUCTR2017-002979-26-NL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
适应症
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. Chemotherapy for previous instances of NIMBC is acceptable.
- •Patients who have received a single instillation of Mitomycin C or equivalent chemotherapy agent immediately after TURBT can be enrolled in the study.
- •Active infection including TB, 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).
- •Appropriate TB tests (e.g. skin or interferon gamma tests) should be performed to exclude TB infection requiring treatment. Additional clinical evaluations including clinical history, physical examination, radiographic findings, other diagnostic procedures and specialist consultations should be performed if necessary.
- •-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)
- •-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]). The following are exceptions to this criterion:
- •-Patients with vitiligo or alopecia
- •-Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- •-Any chronic skin condition that does not require systemic therapy
- •-Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
- •-Patients with celiac disease controlled by diet alone
- •-History of another primary malignancy except for
- •-Malignancy treated with curative intent and with no known active disease = 2 years before the first dose of IP and of low potential risk for recurrence during the study period
- •-Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease
- •-Adequately treated CIS without evidence of disease
- •-Prostate cancer (tumor/node/metastasis stage) of stage = T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention
研究者
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