OncoMatch/Clinical Trials/NCT06356155
Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer
Is NCT06356155 recruiting? Yes, currently enrolling (Sep 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 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
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Urothelial Carcinoma
Disease stage
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
Must meet bone marrow function laboratory criteria outlined in Table 1.
Kidney function
Must meet renal function laboratory criteria outlined in Table 1.
Liver function
Must meet hepatic function laboratory criteria outlined in Table 1. Moderate or severe liver dysfunction (does not meet hepatic function laboratory criteria) is excluded.
Cardiac function
New York Heart Association Class III or higher heart failure excluded.
Patients must have adequate organ and bone marrow function as defined in Table 1. Moderate or severe liver dysfunction (does not meet hepatic function laboratory criteria outlined in Table 1) is excluded. New York Heart Association Class III or higher heart failure excluded.
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
- Fox Chase Cancer Center · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06356155 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immune-mediated therapy, monomethyl auristatin E antibody-drug conjugate disqualifies patients from enrollment.
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