Circulating Tumor DNA Response In Urothelial Cancer

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT07183319
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab & Enfortumab Vedotin (PEV) — DRUG
    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.
  • Pembrolizumab — DRUG
    Patients will receive 400 mg of pembrolizumab every 42 days. During the de-escalation period from PEV.
  • Pembrolizumab & Enfortumab Vedotin (PEV) — DRUG
    If patients experience radiographic progression on pembrolizumab monotherapy, they will undergo rechallenge with PEV.

Study Details

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).

Key Dates

Start date
Jan 19, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab & Enfortumab Vedotin (PEV)
    Patients with metastatic urothelial carcinoma (mUC) will initiate first-line (1L) PEV therapy as the standard of care. At 24 weeks, radiographic imaging will be performed to evaluate disease status. Patients who exhibit either stable disease or ongoing radiographic response, accompanied by a ≥50% reduction in circulating tumor DNA (ctDNA) levels, will transition to pembrolizumab monotherapy as part of a treatment de-escalation strategy. Pembrolizumab will be continued until the occurrence of disease progression or unacceptable toxicity. In the event of progression or intolerance, patients will be re-challenged with first-line PEV therapy and continue treatment until completion of the study-defined treatment period.

Primary Outcome Measure

3 months of progression-free survival (PFS) while on Pembrolizumab Monotherapy. [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73117
Adanma Ayanambakkam, MD
[email protected]
405-271-4022

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