NL-OMON52087招募中2 期
A Phase 2 clinical study to assess efficacy of Induction ipilimumab/nivolumab to spare the Bladder in urothelial bladder cancer (IndiBlade) - Checkpoint inhibition and CRT as bladder sparing treatment in UC
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
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 99（—）
入选标准
- •1. Willing and able to provide informed consent
- •2. Age >= 18 years
- •3. Patients with cT2-4aN0-2M0 urothelial bladder cancer, seeking an alternative
- •to radical cystectomy and/or patients who are medically unfit for surgery.
- •Patients with suspected metastatic disease are not eligible.
- •4. Lymph nodes should be amenable for inclusion into the radiation field
- •according to the multidisciplinary tumor board and/or follow-up consultations
- •between the treating physician and the radiation oncologist.
- •5. World Health Organization (WHO) performance Status 0 or 1.
- •6. Urothelial cancer is the dominant histology (>70%). %). A small cell
- •component is not allowed.
- •7. Formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks
- •from diagnostic TUR available.
- •8. Screening laboratory values must meet the following criteria: WBC >=
- •2.0x109/L, Neutrophils >=1.0x109/L, Platelets >=100 x109/L, Hemoglobin >=5.5
- •mmol/L, GFR>30 ml/min as per Cockcroft-Gault formula, AST <= 2.5 x ULN, ALT <=2.5
- •x ULN, Bilirubin <=1.5 X ULN
- •9. Negative pregnancy test (βHCG in urine or blood) for female patients of
- •childbearing potential within 2 weeks prior to day 1 of start immunotherapy.
- •10. Highly effective contraception for both male and female subjects if the
- •risk of conception exists. Female patients of childbearing potential must
- •comply with contraception methods as requested by the study protocol
排除标准
- •1. Previous pelvic irradiation
- •2. Upper tract urothelial cancer
- •3. Extensive CIS of the bladder
- •4. Bilateral hydronephrosis
- •5. Previous intravenous chemotherapy for bladder cancer
- •6. Contra-indication to one of the study treatment components, or mpMRI
- •7. Subjects with active autoimmune disease in the past 2 years. Patients with
- •diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism,
- •vitiligo, psoriasis or other mild skin disease can still be included
- •8. Documented history of severe autoimmune disease (e.g. inflammatory bowel
- •disease, myasthenia gravis)
- •9. Prior CTLA-4 or PD-(L)1 -targeting immunotherapy
- •10. Known history of Human Immunodeficiency Virus, active tuberculosis, or
- •other active infection requiring therapy at the time of inclusion
- •11. Positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic
- •12. Underlying medical conditions that, in the investigator's opinion, will
- •make the administration of study drug hazardous or obscure the interpretation
- •of adverse events
- •13. Medical condition requiring the use of immunosuppressive medications, with
- •the exceptions of intranasal and inhaled corticosteroids or systemic
- •corticosteroids at physiological doses, which are not to exceed 10 mg/day of
- •prednisone, or an equivalent corticosteroid. Steroids as premedication for
- •hypersensitivity reactions (e.g., CT scan premedication) will be allowed
- •14. Use of other investigational drugs four weeks or five half lifes before
- •study drug administration
- •15. Malignancy, other than urothelial cancer, in the previous 2 years, with a
- •high chance of recurrence (estimated >10%). Patients with low risk prostate
- •cancer (defined as Stage T1/T2a, Gleason score <= 6, and PSA <= 10 ng/mL) who are
- •treatment-naive and undergoing active surveillance are eligible
- •16. Pregnant and lactating female patients
- •17. Major pelvic surgical procedure within 4 weeks prior to enrolment or
- •anticipation of need for a major surgical procedure during the course of the
- •study other than for diagnosis
- •18. Severe infections within 2 weeks prior to enrolment in the study including
- •but not limited to hospitalization for complications of infection, bacteremia,
- •or severe pneumonia
研究者
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