OncoMatch/Clinical Trials/NCT07183319
Circulating Tumor DNA Response In Urothelial Cancer
Is NCT07183319 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab & Enfortumab Vedotin (PEV) and Pembrolizumab for urothelial carcinoma.
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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
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 →Frequently asked questions
Is NCT07183319 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
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