OncoMatch/Clinical Trials/NCT05656235
Renal Retention in High Grade Upper Tract Urothelial Cancer
Is NCT05656235 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Enfortumab vedotin and Pembrolizumab for high grade urothelial carcinoma.
Treatment: Enfortumab vedotin · Pembrolizumab — This trial will evaluate the use of combination pembrolizumab and enfortumab vedotin for patients with high grade non-metastatic (cN0/NxMx, no measurable regional lymph nodes, no metastases) upper tract urothelial cancer (UTUC), preferring to forego standard of care radical nephroureterectomy (RNU) surgery. Currently these patients would not be suitable candidates for neoadjuvant trials, as the patients intention is to forego surgery. The patients are also not candidates for metastatic trials, as the patients have no measurable metastasis. The Investigators hypothesize the combination of pembrolizumab and enfortumab vedotin for patients with high grade cN0/NxMx UTUC deferring RNU will lead to event free survival outcomes similar to that achieved by RNU in a historic dataset.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: enfortumab vedotin or other MMAE-based antibody-drug conjugate
Subjects who have previously received enfortumab vedotin or other MMAE-based ADCs
Cannot have received: PD-1 inhibitor or PD-L1 inhibitor (atezolizumab, pembrolizumab, nivolumab, durvalumab, avelumab)
Subjects who have received prior treatment with a PD-(L)-1 inhibitor for any malignancy, including earlier stage UC, defined as a PD-1 inhibitor or PD-L1 inhibitor (including, but not limited to, atezolizumab, pembrolizumab, nivolumab, durvalumab, or avelumab)
Cannot have received: agent directed to another stimulatory or co inhibitory T-cell receptor (CD137 agonists, CTLA-4 inhibitors, OX-40 agonists)
Subjects who have previously received any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor (including but not limited to CD137 agonists, CTLA-4 inhibitors, or OX-40 agonists)
Cannot have received: chemotherapy, biologics, or investigational agents not otherwise prohibited
Exception: treatment must be completed ≥4 weeks prior to first dose of study treatment; ongoing hormonal/anti hormonal treatment (e.g., for breast cancer) is allowed if eligible per exclusion criteria 14
Subjects who have received anti-cancer treatment with chemotherapy, biologics, or investigational agents not otherwise prohibited by exclusion criterion 1-3 that is not completed 4 weeks prior to first dose of study treatment (ongoing hormonal/anti hormonal treatment, e.g., for breast cancer, is allowed, provided that the subject is eligible per exclusion criteria 14)
Lab requirements
Blood counts
ANC: ≥1500/μL; Platelets: ≥100,000/μL; Hemoglobin: ≥9.0 g/dL or ≥5.6 mmol/L; transfusion of red blood cells to meet eligibility criteria is allowed
Liver function
Total Bilirubin: ≤1.5× ULN; AST (SGOT) and ALT (SGPT): No adjustment in the starting dose is required when administering PADCEV to patients with mild hepatic impairment (total bilirubin 1 to 1.5 × ULN and AST any, or total bilirubin ≤ULN and AST >ULN)
Subjects must have adequate hematologic and organ function as defined by the baseline laboratory values in Table 3. Transfusion of red blood cells to meet eligibility criteria is allowed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins University: Sibley Memorial Hospital · Washington D.C., District of Columbia
- Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
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