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Pembrolizumab + Sacituzumab Govitecan-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer
NCT06524544Phase 3
Key facts
- Status
- Recruiting
- Start
- Dec 2025
- Primary completion
- Dec 2030
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Immune Checkpoint Inhibitors, Small Molecules, Recombinant Proteins and Enzymes
- Conditions
- urothelial carcinoma (UC)
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Overview
Phase 3, randomised, open-label trial of pembrolizumab and sacituzumab govitecan in urothelial carcinoma (UC) (2 arms), sponsored by National Cancer Institute. Primary endpoint: Overall Survival at 5 years. Started Dec 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm I (TPC chemotherapy)
TPC with carboplatin/cisplatin + gemcitabine, or docetaxel, or paclitaxel.
Arm II (pembrolizumab, sacituzumab govitecan-hziy)
Pembrolizumab IV + sacituzumab govitecan-hziy IV.
03
Who it enrols
Adults with locally advanced or metastatic urothelial cancer who have progressed on or after anti-PD(L)1 therapy and enfortumab vedotin, with adequate organ function and ECOG PS 0-2.
04
Endpoints
Primary
Overall Survival
Secondary
Progression-Free Survival
Overall Response Rate
Clinical Benefit Rate
Duration of Response
Adverse Events
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