OncoMatch/Clinical Trials/NCT05868265
A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
Is NCT05868265 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Enfortumab Vedotin for urothelial carcinoma.
Treatment: Enfortumab Vedotin — The purpose of this study is to find out whether the study drug, enfortumab vedotin, is an effective and safe treatment for people who have urothelial carcinoma of the upper urinary tract. Study participants will be people who are not eligible to receive or have chosen not to receive the chemotherapy drug cisplatin for treatment of their cancer. In addition, all participants will be planning on having standard surgery to remove their tumor.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Grade: high grade
radiographically visible tumor stage T2-T4a N0/x M0 disease with positive selective urinary cytology
Prior therapy
Cannot have received: systemic chemotherapy
Exception: for urothelial cancer of the bladder within the last 2 years; prior intravesical treatment such as BCG is allowed
Prior treatment with systemic chemotherapy or radiotherapy for urothelial cancer of the bladder within the last 2 years. (Prior intravesical treatment such as BCG is allowed).
Cannot have received: radiotherapy
Exception: for urothelial cancer of the bladder within the last 2 years; prior intravesical treatment such as BCG is allowed
Prior treatment with systemic chemotherapy or radiotherapy for urothelial cancer of the bladder within the last 2 years. (Prior intravesical treatment such as BCG is allowed).
Cannot have received: antibody-drug conjugate (enfortumab vedotin, other MMAE-based antibody-drug conjugates)
Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs).
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9 /L; Platelets ≥ 100 x 10^9 /L
Kidney function
Estimated or calculated creatinine clearance ≥ 30ml/min but < 60 ml/min (for cisplatin ineligibility)
Liver function
Bilirubin ≤1.5 x ULN; AST and ALT ≤ 2.5 x ULN
Required initial laboratory values: Absolute neutrophil count ≥ 1.5 x 10^9 /L; Platelets ≥ 100 x 10^9 /L; Bilirubin ≤1.5 x ULN; AST and ALT ≤ 2.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited protocol activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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