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Study details
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A Study Comparing Pembrolizumab and Sacituzumab Govitecan to Standard of Care for Urothelial Cancer

National Cancer Institute (NCI)
NCT IDNCT06524544ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

320

Study length

about 3.1 years

Ages

18+

Locations

114 sites in CA, FL, GA +19

What this study is about

Researchers are testing whether pembrolizumab and sacituzumab govitecan, a combination treatment, are more effective than standard chemotherapy in treating urothelial cancer that has spread or cannot be removed surgically. The trial will compare the effectiveness of this new treatment to usual care with drugs like cisplatin, carboplatin, gemcitabine, docetaxel, and paclitaxel.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Questionnaire Administration
  • 2.Receive Pembrolizumab
  • 3.Receive Sacituzumab Govitecan
  • +3 more

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Injection / IVInjection / IV

How treatment is administered

Treatment Assignment
Randomized (Open Label)

You are randomly assigned, but you will know your treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

carboplatin, cisplatin (Platinum chemotherapy; crosslinks DNA to stop replication), docetaxel, gemcitabine, paclitaxel (Taxane chemotherapy; stabilizes microtubules), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer), sacituzumab govitecan

Drug routes

injection, intravenous, infusion, injection (Injection)

Endpoints

Primary: Overall survival (OS)

Secondary: Clinical benefit rate (CBR), Duration of response (DOR), Incidence of adverse events (AEs), Overall response rate (ORR), Progression-free survival (PFS)

Procedures

diagnostic, imaging

Body systems

Oncology