Adult patients with cT2-4aN0-1 urothelial bladder cancer, who are amenable for a bladder-sparing approach, will be included. Patients must have a WHO performance status 0 or 1
Conditions
Brief summary
Estimated 2-year bladder-intact event-free survival (BI-EFS) for the intention-to-treat population, measured from day 1 of treatment until the moment of analysis.
Detailed description
Feasibility of no consolidation vs consolidative RT (followed by maintenance pembrolizumab) in cCR patients after induction EVP: rate of cystectomy and/or muscle-invasive recurrence per arm, Overall survival (OS), Progression-free survival (PFS), Metastasis-free survival (MFS), Bladder function of no consolidation vs consolidative RT in cCR patients after induction EVP using bladder-specific QOL assessments., Muscle-invasive recurrence in patients not undergoing cystectomy, Non-muscle-invasive bladder recurrence in patients not undergoing cystectomy, Safety of EVP induction by NCI CTC-AE 5.0 criteria, Prediction of BI-EFS by circulating tumor DNA (ctDNA) assessment
Interventions
DRUGKEYTRUDA 25 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 |
|---|---|
| Estimated 2-year bladder-intact event-free survival (BI-EFS) for the intention-to-treat population, measured from day 1 of treatment until the moment of analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of no consolidation vs consolidative RT (followed by maintenance pembrolizumab) in cCR patients after induction EVP: rate of cystectomy and/or muscle-invasive recurrence per arm, Overall survival (OS), Progression-free survival (PFS), Metastasis-free survival (MFS), Bladder function of no consolidation vs consolidative RT in cCR patients after induction EVP using bladder-specific QOL assessments., Muscle-invasive recurrence in patients not undergoing cystectomy, Non-muscle-invasive bladder recurrence in patients not undergoing cystectomy, Safety of EVP induction by NCI CTC-AE 5.0 criteria, Prediction of BI-EFS by circulating tumor DNA (ctDNA) assessment | — |
Outcome results
None listed