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OncoMatch/Clinical Trials/NCT07183319

Circulating Tumor DNA Response In Urothelial Cancer

Is NCT07183319 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab & Enfortumab Vedotin (PEV) and Pembrolizumab for urothelial carcinoma.

Phase 2RecruitingUniversity of OklahomaNCT07183319Data as of May 2026

Treatment: Pembrolizumab & Enfortumab Vedotin (PEV) · Pembrolizumab · Pembrolizumab & Enfortumab Vedotin (PEV)The purpose of this clinical trial is to evaluate the effectiveness of pembrolizumab monotherapy following 24 weeks of frontline pembrolizumab \& Enfortumab Vedotin (PEV) in patients with metastatic urothelial cancer (mUC).

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: antibody-drug conjugate (enfortumab, vedotin, other monomethyl auristatin E (MMAE)-based ADCs)

Previously received enfortumab, vedotin, or other monomethyl auristatin E (MMAE)-based ADCs.

Cannot have received: anti-PD-1 therapy

Exception: within 12 months

Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor for any malignancy, including earlier stage UC, defined as a PD-1 inhibitor or PD-L1 inhibitor within 12 months.

Cannot have received: anti-PD-L1 therapy

Exception: within 12 months

Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor for any malignancy, including earlier stage UC, defined as a PD-1 inhibitor or PD-L1 inhibitor within 12 months.

Cannot have received: systemic therapy for locally advanced or metastatic urothelial carcinoma

Exception: neoadjuvant chemotherapy with recurrence >12 months from completion of therapy permitted; adjuvant chemotherapy or ICPIs therapy following cystectomy with recurrence >12 months from completion of therapy permitted

Participants must not have received prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: Participants that received neoadjuvant chemotherapy with recurrence >12 months from completion of therapy are permitted. Participants that received adjuvant chemotherapy or ICPIs therapy following cystectomy with recurrence >12 months from completion of therapy are permitted.

Lab requirements

Blood counts

hb ≥ 8.0 g/dl; anc ≥ 1.5x10^9 cells/l

Kidney function

crcl ~30 ml/min

Liver function

total bilirubin ≤ 1.5 mg/dl; alt and ast within normal limits

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • OU Health Stephenson Cancer Center · Oklahoma City, Oklahoma

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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