NL-OMON52369招募中不适用
A Phase 1b trial in Stage II-III urothelial cancer to explore pre-operative immunotherapy - TURANDOT - Pre-operative immunotherapy in stage II-III urothelial cancer
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
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. Resectable muscle-invasive UC (upper urinary tract allowed), defined as:
- •- cT2-4aN0M0 OR
- •- cT1-4aN1-3M0
- •2. World Health Organization (WHO) performance Status 0 or 1.
- •3. Urothelial cancer is the dominant histology (>70%).
- •4. PD-L1 status must be determined using the 22C3 pharmDx test. Combined
- •positivity score (CPS) must be >10 under amendment V3.
- •5. 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, AST <= 1.5 x ULN, ALT <=1.5 x ULN, Bilirubin <=1.5 X ULN
- •6. Negative pregnancy test
- •7. Age >= 18 years
排除标准
- •1. 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.
- •2. Documented history of severe autoimmune disease (e.g. inflammatory bowel
- •disease, myasthenia gravis).
- •3. Prior CTLA-4 or PD-1/PD-L1-targeting immunotherapy.
- •4. Known history of Human Immunodeficiency Virus infection, or tuberculosis, or
- •other active infection requiring therapy at the time of inclusion.
- •5. Positive tests for Hepatitis B or Hepatitis C
- •6. Underlying medical conditions that, in the investigator's opinion, will make
- •the administration of study drug hazardous or obscure the interpretation of
- •adverse events
- •7. Medical condition requiring the use of immunosuppressive medications
- •8. Use of other investigational drugs before study drug administration
- •9. Malignancy, other than urothelial cancer, in the previous 2 years, with a
- •high chance of recurrence (estimated >10%).
- •10. Pregnant and lactating female patients.
- •11. Major 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.
- •12. Severe infections within 2 weeks prior to enrolment in the study
- •13. Significant cardiovascular disease, such as New York Heart Association
- •cardiac disease (Class II or greater), myocardial infarction within 3 months
- •prior to enrolment, unstable arrhythmias and unstable angina.
- •14. Previous intravenous chemotherapy for bladder cancer. Prior low-dose
- •sensitizing chemotherapy used for combined modality treatment, or radiation
- •alone, is allowed if patients have recurred after an initial response. Patients
- •with residual disease after (chemo)radiation for bladder cancer are not
研究者
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