OncoMatch/Clinical Trials/NCT06524544
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
Is NCT06524544 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for locally advanced urothelial carcinoma.
Treatment: Carboplatin · Cisplatin · Docetaxel · Gemcitabine · Paclitaxel · Pembrolizumab · Sacituzumab Govitecan — This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan to standard of care in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan to kill them. The usual treatment approach is treatment with chemotherapy such as cisplatin, carboplatin, gemcitabine, docetaxel or paclitaxel. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Giving pembrolizumab and sacituzumab govitecan may be more effective than usual care of carboplatin or cisplatin with gemcitabine, docetaxel or paclitaxel in treating patients with locally advanced or metastatic urothelial cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Allowed: FGFR3 susceptible alteration
Disease stage
Required: Stage LOCALLY ADVANCED (UNRESECTABLE OR NOT AMENABLE TO CURATIVE INTENT THERAPY), IV
locally advanced (unresectable or not amenable to curative intent therapy) or metastatic urothelial cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy — any disease/therapy setting for UC
prior exposure to anti-PD(L)1 therapy [anti-PD(L)1 monotherapy or as a combination regimen in any disease/therapy setting for UC. Patients must have received at least 1 dose of anti-PD(L)1 therapy
Must have received: systemic therapy — advanced/metastatic disease setting
≥ 1 line of systemic therapy given in the advanced/metastatic disease setting
Must have received: FGFR inhibitor
For tumors with FGFR3 + susceptible alteration (for FGFR inhibitor), patients must have received a prior FGFR inhibitor unless contraindicated per physician discretion
Must have received: antibody-drug conjugate (enfortumab vedotin) — any disease/therapy setting
must have received prior enfortumab vedotin in any disease/therapy setting unless contraindicated per physician
Cannot have received: TROP-2 directed therapy (sacituzumab govitecan)
no prior exposure to sacituzumab govitecan or other TROP-2 directed therapies
Cannot have received: antibody-drug conjugate containing topoisomerase I inhibitor (trastuzumab deruxtecan)
no prior exposure to ...antibody-drug conjugate that contains topo-isomerase I inhibitor, e.g. trastuzumab deruxtecan
Lab requirements
Blood counts
ANC ≥ 1,500/uL; Platelets ≥ 100,000/uL; Albumin ≥ 3 g/dL
Kidney function
Creatinine clearance (CrCl) ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5 x institutional ULN; AST and ALT ≤ 3 × institutional ULN or ≤ 5.0 x institutional ULN if known liver metastases
ANC ≥ 1,500/uL (obtained ≤ 14 days prior to randomization); Platelets ≥ 100,000/uL (obtained ≤ 14 days prior to randomization); Albumin ≥ 3 g/dL (obtained ≤ 14 days prior to randomization); Total bilirubin ≤ 1.5 x institutional ULN (obtained ≤ 14 days prior to randomization); AST and ALT ≤ 3 × institutional ULN or ≤ 5.0 x institutional ULN if known liver metastases (obtained ≤ 14 days prior to randomization); Creatinine clearance (CrCl) ≥ 30 mL/min (obtained ≤ 14 days prior to randomization)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
- UF Health Cancer Institute - Gainesville · Gainesville, Florida
- Kootenai Health - Coeur d'Alene · Coeur d'Alene, Idaho
- Kootenai Clinic Cancer Services - Post Falls · Post Falls, Idaho
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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