765
Participants
Start Date
January 31, 2026
Primary Completion Date
March 31, 2033
Study Completion Date
March 31, 2033
Sacituzumab govitecan
"SG is administered at 10 mg/kg as an intravenous (i.v.) infusion on Days 1 and 8 of a 21-day cycle.~The dose of SG will be calculated based on actual weight at randomization (using weight obtained either at enrolment or on Cycle 1 Day 1) and remains constant throughout the study, unless there is a \> 10% change in body weight from baseline. Modifications to the study drug doses administered should be made for a \> 10% change in body weight from baseline and according to local and regional prescribing standards. Dose modifications for changes in body weight \< 10% may be made according to local institutional guidelines.~SG is administered via i.v. infusion as described below with additional information available in the current version of the SmPC."
Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA]
Pembrolizumab 200 mg will be administered as a 30-minute i.v. infusion every 3 weeks.
SoC Chemotherapy
Standard of care chemotherapy as per common treatment guidelines and recommendations
Collaborators (1)
Gilead Sciences
INDUSTRY
West German Study Group
OTHER