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Circulating Tumor DNA Response In Urothelial Cancer

NCT07183319 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-02

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Natera, Inc.

    collaborator INDUSTRY

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Adanma Ayanambakkam, MD · University of Oklahoma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-19
Primary Completion
2028-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07183319 on ClinicalTrials.gov