Summary
Description of a phase 3 clinical trial for adjuvant pembrolizumab post-cystectomy in patients with high-risk muscle-invasive urothelial carcinoma of the bladder and upper tract.
Bladder Cancer Program
US · IL
NIH RePORTER
grant
closed
#nih-1ZIABC011351-16
What they want
Initiated a phase 3 clinical trial of adjuvant pembrolizumab post-cystectomy in patients with high-risk muscle-invasive urothelial carcinoma of the bladder and upper tract. Patients were randomly assigned, in a 1:1 ratio, to receive pembrolizumab at a dose of 200 mg every 3 weeks for 1 year or to undergo observation. Randomization was stratified according to pathological stage, centrally tested programmed death ligand 1 (PD-L1) status, and previous neoadjuvant chemotherapy. The coprimary end points were disease-free survival and overall survival in the intention-to-treat population. The trial was considered successful if either disease-free survival or overall survival was significantly longer with pembrolizumab than with observation.
Technical requirements
- Pembrolizumab at a dose of 200 mg every 3 weeks for 1 year
- Randomization stratified by pathological stage, centrally tested PD-L1 status, and previous neoadjuvant chemotherapy
Risks & flags
Incumbent: Principal Investigator (researcher)
- This text describes an already initiated and conducted research project, not an open procurement opportunity. No bidding instructions, due dates, or requirements for new vendors are present.
