Adult patients with resectable muscle-invasive urothelial cancer of the bladder, defined as stage II and IIIa UC, who have not yet undergone systemic therapy for UBC.
Conditions
Brief summary
Pathological complete response (pCR), defined as pT0N0 or pTisN0, at cystectomy
Detailed description
Percentage of patients that completes cystectomy within 12 weeks of start of treatment. Patients who elect to not undergo surgery or have a delay due to logistical reasons not related to study treatment will be excluded from this analysis., Overall Survival. Event-Free Survival; events are defined as: - Disease progression precluding surgery - Disease recurrence outside the urinary tract (distant metastases, pelvic recurrence) - Muscle invasive recurrence in the bladder or distal ureters - Switch to other treatments directed at systemic urothelial cancer, Immune-related adverse events (irAE) according to CTCAE 5.0 criteria
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR), defined as pT0N0 or pTisN0, at cystectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients that completes cystectomy within 12 weeks of start of treatment. Patients who elect to not undergo surgery or have a delay due to logistical reasons not related to study treatment will be excluded from this analysis., Overall Survival. Event-Free Survival; events are defined as: - Disease progression precluding surgery - Disease recurrence outside the urinary tract (distant metastases, pelvic recurrence) - Muscle invasive recurrence in the bladder or distal ureters - Switch to other treatments directed at systemic urothelial cancer, Immune-related adverse events (irAE) according to CTCAE 5.0 criteria | — |
Countries
Netherlands
Outcome results
None listed