Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

September 20, 2023

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Muscle-invasive Urothelial Carcinoma of the Bladder
Interventions
DRUG

Sacituzumab govitecan is a humanized mAb with a hydrolysable linker through which SN-38 is conjugated to the humanized mAb hRS7 IgG1κ to enhance the delivery of SN-38 to Trop-2- expressing tumors, whi

"Neoadjuvant treatment: 7,5mg/kg sacituzumab-govitecan IV, on days 1, 8, of each 21 day cycle; Pembrolizumab will be administered in combination with sacituzumab-govitecan on day 1, every 21 days, at the standard dose of 200 mg intravenously. A total of 4 cycles is planned before surgery.~After surgery patients will receive additional 13 cycles of pembrolizumab at the standard dose, every 3 weeks, accounting for a total of 17 cycles of perioperative pembrolizumab (neoadjuvant + adjuvant)."

Trial Locations (1)

20132

Fondazione San Raffaele, Milan

All Listed Sponsors
lead

Claudia Guerrieri

OTHER

NCT05535218 - Pembrolizumab-Sacituzumab Govitecan Combination to Treat High-risk, Localized Bladder Cancer | Biotech Hunter | Biotech Hunter