NL-OMON55844
Recruiting
Not Applicable
Phase 1B Study to assess safety and efficacy of Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy (NABUCCO) - NABUCCO
Antoni van Leeuwenhoek Ziekenhuis0 sites54 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 54
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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