Phase 1B Study to assess safety and efficacy of Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy (NABUCCO) - NABUCCO

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 54 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•High-risk resectable urothelial cancer (upper urinary tract allowed), defined
•as stage III UC:
•- cT3-4aN0M0 OR
•- >=T1-4aN1-3M0
•- Patients who refuse neoadjuvant/induction cisplatin based chemotherapy or in
•whom neoadjuvant cisplatin based therapy is not appropriate
•- Age > 18 years
•- World Health Organization (WHO) performance Status 0 or 1.
•- 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 <= 2.5 x ULN, ALT <=2.5 x ULN, Bilirubin <=1.5 X ULN
•- Negative pregnancy test within 2 weeks of Day 1 Cycle 1 for female patients
•of childbearing potential.

•- No high risk profile as defined by criteria
•- Previous intravenous chemotherapy for bladder cancer i.v. Prior
•chemoradiation is allowed.
•- 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.
•- Prior CTLA-4 or PD-1/PD-L1-targeting immunotherapy.
•- Pregnant and lactating female patients.
•- Known history of Human Immunodeficiency Virus, positive tests for Hepatitis B
•surface antigen or Hepatitis C ribonucleic acid (RNA), active tuberculosis, or
•other active infection requiring therapy at the time of inclusion.
•- Patients in whom use of a colon segment for urinary diversion is planned

发起方

Antoni van Leeuwenhoek Ziekenhuis