OncoMatch/Clinical Trials/NCT06356155
Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer
Is NCT06356155 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Enfortumab vedotin and Pembrolizumab for urothelial carcinoma.
Treatment: Enfortumab vedotin · Pembrolizumab — This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CT1-4, N0-1
Grade: high-grade
cT1-4 N0-1 M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immune-mediated therapy
Prior exposure to immune-mediated therapy, including but not limited to, other anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4), anti-PD1, anti-PD-L1, anti-PD-L2 antibodies, and therapeutic anticancer vaccines
Cannot have received: monomethyl auristatin E antibody-drug conjugate
Prior exposure to monomethyl auristatin E antibody-drug conjugates (MMAE ADC)
Lab requirements
Blood counts
adequate organ and bone marrow function as defined in Table 1
Kidney function
Creatinine clearance 45 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or measured by 24-hour urine collection
Liver function
Moderate or severe liver dysfunction (does not meet hepatic function laboratory criteria outlined in Table 1) [excluded]
Cardiac function
Absence of New York Heart Association Class III or higher heart failure
Patients must be eligible for cisplatin. Cisplatin eligibility is defined as meeting all of the following criteria: a. Creatinine clearance 45 mL/min calculated by Cockcroft-Gault equation (using actual body weight) or measured by 24-hour urine collection. b. Absence of Grade 2 peripheral neuropathy. c. Absence of New York Heart Association Class III or higher heart failure. ... adequate organ and bone marrow function as defined in Table 1
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan Comprehensive Cancer Center · Ann Arbor, Michigan
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