NL-OMON52087
Recruiting
Phase 2
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 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Urothelial carcinoma of the bladder and bladder cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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