NL-OMON50693招募中3 期
A phase III randomized, open-label, multi-centre, global study of Durvalumab and Bacillus Calmette-Guerin (BCG) administered as combination therapy versus BCG alone in high-risk, BCG-naive non-muscle-invasive bladder cancer patients - POTOMAC
Astra Zeneca0 个研究点目标入组 11 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >=18 years at the time of screening.
- •2. Written informed consent.
- •3. 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
- •4. Local histological confirmation (based on pathology report) of high-risk
- •transitional
- •cell carcinoma of the urothelium of the urinary bladder confined to the mucosa
- •submucosa. A high-risk tumor is defined as one of the following:
- •- T1 tumor
- •- High grade/G3 tumor
- •- Multiple and recurrent and large (with diameter of largest tumor >=3 cm)
- •tumors (all conditions must be met in this point)
- •5. Complete resection of all Ta/T1 papillary disease prior to randomization,
- •with the TURBT removing high-risk NMIBC performed not more than 4 months before
- •randomization in the study. Patients with residual CIS after TURBT are eligible.
- •6. No prior radiotherapy for bladder cancer.
- •7. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0 or 1 at screening.
- •8. Body weight >30 kg.
- •9. Must have a life expectancy of at least 12 weeks.
- •10. No prior exposure to immune-mediated therapy of cancer including, but not
- •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
- •be excluded.
- •11. Must be a candidate for BCG treatment.
- •12. Adequate organ and marrow function as defined below:
- •- Hemoglobin >=9.0 g/dL
- •- Absolute neutrophil count >=1.0 × 109/L
- •- Platelet count >=75 × 109/L
- •- Serum bilirubin <=1.5 × the upper limit of normal (ULN). This will not apply
- •to patients with confirmed Gilbert*s syndrome, who will be allowed in
- •consultation with their physician.
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 ×
- •- Measured creatinine clearance (CL) >40 mL/min or calculated creatinine CL >40
- •mL/min as determined by Cockcroft-Gault (using actual body weight)
- •Creatinine CL (mL/min) = Weight (kg) × (140 - Age) / 72 × serum creatinine
- •Creatinine CL (mL/min) = Weight (kg) × (140 - Age) × 0.85 / 72 × serum
- •creatinine (mg/dL)
- •13. Postmenopausal or negative pregnancy test.
- •14 . At screening, provision of a tumor biopsy that is formalin-fixed and
- •paraffin-embedded (FFPE) is mandatory. Tumor sample should be relevant to the
- •high-risk NMIBC which is the reason for inclusion in the study, preferably,
- •from TURBT removing this tumor.
排除标准
- •1. Evidence of muscle-invasive, locally advanced, metastatic, and/or
- •extra-vesical bladder cancer (ie, T2, T3, T4, and / or stage IV).
- •2. Predominantly variant histology such as micropapillary, plasmocytoid,
- •nested, sarcomatoid, microcystic, squamous and adeno variants of urothelial
- •carcinoma representing more than 50% of tumor tissue or other than urothelial
- •tumors as assessed by pathology
- •3. Evidence of lymphovascular invasion of bladder tumor.
- •4. Immediate cystectomy is indicated.
- •5. Known or documented absolute and/or relative contraindication of adjuvant
- •intravesical BCG treatment.
- •6. Concurrent extravesical (ie, urethra, ureter, or renal pelvis),
- •non-muscle-invasive transitional cell carcinoma of the urothelium.
- •7. Involvement in the planning and/or conduct of the study.
- •8. Previous investigational product (IP) assignment in the present study.
- •9. Concurrent enrollment in another clinical study.
- •10. Participation in another clinical study with an IP during the last 28 days
- •or 5 half-lives of the respective Investigational Product, whichever is longer
- •prior to study enrollment.
- •11. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
- •treatment. Chemotherapy for previous instances of NMIBC 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.
- •12. Previous or concurrent treatment with potent systemic immunostimulatory
- •agents (i.e systemic use of interleukins, interferons, glatiramer or similar
- •13. Major surgical procedure within 28 days prior to randomization.
- •14. History of allogenic organ transplantation.
- •15. Active or prior documented autoimmune or inflammatory disorders,
- •diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener
- •16. Uncontrolled intercurrent illness, including but not limited to, ongoing or
- •active infection, symptomatic congestive heart failure, uncontrolled
- •hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious
- •chronic GI conditions associated with diarrhea, or psychiatric illness/social
- •situations that would limit compliance with study requirement, substantially
- •increase risk of incurring AEs, or compromise the ability of the patient to
- •give written informed consent.
- •17. History of another primary malignancy.
- •18. History of active primary immunodeficiency.
- •19. Intentionally Omitted.
- •20. Active infection including TB, hepatitis B, hepatitis C or HIV.
- •21. Current or prior use of immunosuppressive medication within 14 days before
- •the first dose of durvalumab.
- •22. Receipt of live attenuated vaccine within 90 days (approximately 5
- •half-lives) prior to the first dose of IP.
- •23. Female patients who are pregnant or breastfeeding or male or female
- •patients of
- •reproductive potential who are not willing to employ effective birth control
- •screening to 90 days after the last dose of durvalumab.
- •24. Known allergy or hypersensitivity to any of the study drugs or any of the
- •drug excipients.
- •25. Prior randomization or treatment in a previous durvalumab clinical study
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