OncoMatch/Clinical Trials/NCT06524544
A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
Is NCT06524544 recruiting? Yes, currently enrolling (Sep 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-hziy 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-hziy is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan-hziy. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan-hziy 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-hziy 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
Treatments studied
Immunotherapy
Targeted therapy
Chemotherapy
Cancer type
Urothelial Carcinoma
Biomarker criteria
Excluded: TACSTD2 expression
Patient must have had no prior exposure to Sacituzumab govitecan-hziy or other TROP-2 directed therapies or antibody-drug conjugate that contains topo-isomerase I inhibitor, e.g. trastuzumab deruxtecan
Excluded: UGT1A1 deficiency
Patient must not have a known genetic UGT1A1 deficiency (Gilbert's syndrome). Patients with variant type UGT1A1*28 allele may have increased levels of SN-38 metabolite (due to reduced SN-38 metabolism and clearance) and are at higher risk for severe adverse events when compared to wild-type.
Allowed: FGFR3 susceptible alteration
For tumors with known FGFR3+ susceptible alteration (for FGFR inhibitor), patients must have received a prior FGFR inhibitor unless contraindicated per physician discretion
Allowed: NECTIN4 expression
Patient must have received prior enfortumab vedotin or any other Nectin-4 directed therapy or other MMAE-containing therapy in any disease/therapy setting unless contraindicated per physician
Disease stage
Required: Stage LOCALLY ADVANCED (UNRESECTABLE AND/OR NOT AMENABLE TO CURATIVE INTENT THERAPY), IV
locally advanced (unresectable and/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 urothelial carcinoma
Patient must have had 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
Patient must have had ≥ 1 line of systemic therapy given in the advanced/metastatic disease setting, except for patients who had received anti-PD(L)1 + enfortumab vedotin in the localized disease setting (e.g., neoadjuvant and/or adjuvant) and had cancer progression within 12 months from the last systemic therapy dose
Cannot have received: Sacituzumab govitecan-hziy or other TROP-2 directed therapies or antibody-drug conjugate that contains topo-isomerase I inhibitor (Sacituzumab govitecan-hziy, trastuzumab deruxtecan)
Patient must have had no prior exposure to Sacituzumab govitecan-hziy or other TROP-2 directed therapies or 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; Hemoglobin (Hb) ≥ 8.5 g/dl; 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; Platelets ≥ 100,000/uL; Albumin ≥ 3 g/dL; Total bilirubin ≤ 1.5 x institutional ULN; AST/ALT ≤ 3 × institutional ULN or ≤ 5.0 x institutional ULN if known liver metastases; Creatinine clearance (CrCl) ≥ 30 mL/min; Hemoglobin (Hb) ≥ 8.5 g/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cancer Center at Saint Joseph's · Phoenix, Arizona
- 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
- Emory University Hospital Midtown · Atlanta, Georgia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06524544 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Sacituzumab govitecan-hziy or other TROP-2 directed therapies or antibody-drug conjugate that contains topo-isomerase I inhibitor disqualifies patients from enrollment.
Are patients with TACSTD2 alterations eligible?
No. TACSTD2 expression is an exclusion criterion.
Are patients with UGT1A1 alterations eligible?
No. UGT1A1 deficiency is an exclusion criterion.
What disease stage is eligible?
Stage LOCALLY ADVANCED (UNRESECTABLE AND/OR NOT AMENABLE TO CURATIVE INTENT THERAPY) or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages