A Phase III Randomized, Open-Label, Multi-Center, GlobalStudy of Durvalumab and Bacillus Calmette-Guerin (BCG)Administered as Combination Therapy Versus BCG Alone inHigh-Risk, BCG Naïve Non Muscle Invasive Bladder Cancer Patients (POTOMAC) - D419JC00001(POTOMAC)

AstraZeneca AB0 个研究点目标入组 1,026 人开始时间: 2024年1月30日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 1,026

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•BCG-naïve (patients who have not received priorintravesical BCG or who previously received but stoppedBCG more than 3 years before study entry are eligible). - Local histological confirmation (based on pathologyreport) of high-risk transitional cell carcinoma of theurothelium of the urinary bladder confined to the mucosaor submucosa.A high-risk tumor is defined as one of thefollowing: -T1 tumor -High grade/G3 tumor -CIS -Multiple andrecurrent and large (with diameter of largesttumor =3cm) tumors (all conditions must be met in this point) -Complete resection of all Ta/T1 papillary disease prior torandomization, with the TURBT removing high-risk NMIBCperformed not more than 4 months before randomizationin the study. Patients with residual CIS after TURBT are eligible. -No prior radiotherapy for bladder cancer. -No prior exposure to immune-mediated therapy of cancerincluding, but not limited to, other anti CTLA-4, anti-PD-1,anti-PD-L1, and anti-programmed cell death ligand 2antibodies. Patients who have been treated with anticancer vaccines will be excluded.

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 renalpelvis), non-muscle-invasive transitional cell carcinoma of the urothelium. -Previous investigational product (IP) assignment in the present study. -Any concurrent chemotherapy, IP, biologic, or hormonaltherapy for cancer treatment. Concurrent use of hormonaltherapy for noncancer related conditions (eg, hormonereplacement therapy) is acceptable. Chemotherapy for previous instances of NMIBC is acceptable. Patients who have received a single instillation of Mitomycin C orequivalent chemotherapy agent immediately after TURBT can be enrolled in the study. -Active infection including TB, hepatitis B (known positivehepatitis B virus [HBV] surface antigen [HBsAg] result),hepatitis C virus (HCV), or human immunodeficiency virus(HIV [positive HIV] 1/2) antibodies. Patients with a pastor resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) areeligible. 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, and 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 steroidinjections (eg, intra articular injection) Systemic corticosteroids at physiologic doses not toexceed 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 inflammatorydisorders (including inflammatory bowel disease [eg,colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegenersyndrome [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 Hashimotosyndrome) stable on hormone replacement. Any chronic skin condition that does not requiresystemic therapy Patients without active disease in the last 5 years maybe 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 noknown active disease = 2 years before the first dose of IPand of low potential risk for recurrence during study period Adequately treated nonmelanoma skin cancer or lentigomaligna 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

发起方

AstraZeneca AB

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