OncoMatch/Clinical Trials/NCT04724018
Sacituzumab Govitecan Plus EV in Metastatic UC
Is NCT04724018 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) for urothelial cancer.
Treatment: Sacituzumab Govitecan (SG) · Enfortumab vedotin-ejfv (EV) · Pembrolizumab — Phase I of this research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin, and Pembrolizumab to assess the efficacy of this drug combination. The names of the study drugs in these investigational combinations are: * Enfortumab Vedotin * Sacituzumab Govitecan * Pembrolizumab
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — adjuvant/neoadjuvant or locally advanced/metastatic
must have received prior treatment with platinum containing therapy defined as within the adjuvant/neoadjuvant setting with ≥ ypT2 disease at surgery or recurrent or progressive disease within 12 months or receiving treatment with platinum in locally advanced or metastatic setting
Must have received: checkpoint inhibitor — locally advanced or metastatic urothelial cancer
must have received a checkpoint inhibitor (CPI) in locally advanced or metastatic urothelial cancer setting. Patients who received CPI therapy in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during or within 12 months of therapy completion are eligible. A CPI is defined as a PD-1 or PD-L1 inhibitor.
Cannot have received: topoisomerase 1 inhibitor
Have previously received topoisomerase 1 inhibitors, SG or EV
Cannot have received: Sacituzumab govitecan (Sacituzumab govitecan)
Have previously received topoisomerase 1 inhibitors, SG or EV
Cannot have received: Enfortumab vedotin (Enfortumab vedotin)
Have previously received topoisomerase 1 inhibitors, SG or EV
Lab requirements
Blood counts
Leukocytes ≥3,000/mcL; Absolute neutrophil count ≥1,500/mcL; Platelets ≥100,000/mcL
Kidney function
Glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2 (by Cockcroft Gault formula)
Liver function
Total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤2.5x institutional ULN OR ≤5x ULN with liver metastases and serum albumin > 3 g/dL
Cardiac function
Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
Participants must have adequate organ and marrow function as defined below: Leukocytes ≥3,000/mcL; Absolute neutrophil count ≥1,500/mcL; Platelets ≥100,000/mcL; Total bilirubin ≤ institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤2.5x institutional ULN OR ≤5x ULN with liver metastases and serum albumin > 3 g/dL; Glomerular filtration rate (GFR) ≥30 mL/min/1.73 m2 (by Cockcroft Gault formula); cardiac risk assessment NYHA class 2B or better.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana Farber Cancer Institute · Boston, Massachusetts
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