NCT07183319

Circulating Tumor DNA Response In Urothelial Cancer

Circulating Tumor DNA Response Adapted Treatment De-escalation Metastatic Urothelial Carcinoma (CT-READ)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This study aims to evaluate the de-escalation of therapy in patients with metastatic urothelial carcinoma (mUC). Patients will begin treatment with first-line (1L) (PEV) per standard of care. After 24 weeks, patients will be assessed for disease progression. Those who demonstrate stable disease or ongoing disease radiographic response and a ≥50% reduction in circulating tumor DNA (ctDNA) levels will enter the de-escalation phase. This phase consists of transitioning from PEV to pembrolizumab monotherapy. If, during the de-escalation period, patients exhibit disease progression or increased toxicity, they will be rechallenged with PEV.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab & Enfortumab Vedotin (PEV)	Patients in the study will receive 1L PEV with 1.25 mg/kg of EV on day 1 and day 8 every 21 days, and 200 mg of pembrolizumab every 21 days.
DRUG	Pembrolizumab	Patients will receive 400 mg of pembrolizumab every 42 days. During the de-escalation period from PEV.
DRUG	Pembrolizumab & Enfortumab Vedotin (PEV)	If patients experience radiographic progression on pembrolizumab monotherapy, they will undergo rechallenge with PEV.

Timeline

• Start date: 2026-01-19
• Primary completion: 2028-03-01
• Completion: 2029-03-01
• First posted: 2025-09-19
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study