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Circulating Tumor DNA Response In Urothelial Cancer

This study is looking at a new way to treat unresectable, locally advanced, or metastatic urothelial carcinoma (a type of bladder cancer). It's testing if patients can safely reduce their treatment after an initial period. You would first receive a combination of two drugs, Pembrolizumab and Enfortumab Vedotin (PEV). If your cancer responds well and your circulating tumor DNA (ctDNA) levels decrease significantly after 24 weeks, you might then switch to just Pembrolizumab. If your cancer progresses or you experience side effects on Pembrolizumab alone, you would go back to the PEV combination. The study aims to see how many patients remain progression-free on Pembrolizumab monotherapy after 3 and 6 months. This study is currently unclear on its status and plans to enroll 30 participants aged 18 and older with measurable disease.

Study design
This is an interventional study planning to enroll 30 participants. It explores a de-escalation approach, starting with combination therapy and potentially moving to a single drug.
What's involved
You would receive Pembrolizumab and Enfortumab Vedotin every 21 days initially. If eligible for de-escalation, you would then receive Pembrolizumab every 42 days.
Compensation
Not stated in the trial record.
Follow-up
The study measures progression-free survival at 3 months and 6 months while on Pembrolizumab monotherapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07183319

Circulating Tumor DNA Response In Urothelial Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Oklahoma
~30 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:Pembrolizumab & Enfortumab Vedotin (PEV)Pembrolizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
3 months of progression-free survival (PFS) while on Pembrolizumab Monotherapy.
Measured over 3 months
+1 more outcome measured

Conditions

Urothelial Carcinoma

Explore related trials

Urothelial CarcinomaCirculating Tumor-Derived DNA Negative

Where it's being run

1 sites across 1 states
Oklahoma1

Study leadership

  • Adanma Ayanambakkam, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma

Who to contact

Lead Onco Nurse
[email protected]
405-271-8777
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have histologically documented unresectable, locally advanced, or metastatic urothelial carcinoma.
Measurable disease according to the New Response Evaluation Criteria in Solid Tumors (RECIST v1.1)38
Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgment.
Archival tumor tissue comprising muscle-invasive urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma must be available for tumor-informed ctDNA analysis.
Meets Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
Adequate hematologic and organ function (Hb ≥ 8.0 g/dL; ANC ≥ 1.5x109 cells/L; CrCl \~30 mL/min; total bilirubin ≤ 1.5 mg/dL; ALT and AST within normal limits).

Exclusion

Previously received enfortumab, vedotin, or other monomethyl auristatin E (MMAE)-based ADCs.
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.
Has received anti-cancer treatment with chemotherapy, biologics, or investigational agents not otherwise prohibited by exclusion criterion 1-3 that is not completed within 28 days prior to cycle 1 day 1.
Has uncontrolled diabetes or ≥ grade III peripheral neuropathy.
Patient's estimated life expectancy is less than 12 weeks.
Has untreated central nervous system metastases.
Experiences ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1 or returned to baseline.
Is currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal). Routine antimicrobial prophylaxis is permitted.
Has known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection.
Has history of another invasive malignancy requiring treatment within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy (excluding localized prostate cancer or basal cell carcinoma of skin or squamous cell carcinoma of the skin).
Has documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months.
Received radiotherapy within 2 weeks.
Received major surgery (defined as requiring general anesthesia and \>24-hour inpatient hospitalization) within 2 weeks.
Known severe (≥ Grade 3) hypersensitivity to any EV excipient contained in the drug formulation of EV.
Has active keratitis or corneal ulcerations.
Has a history of autoimmune disease that has required systemic immunosupressive treatment in the past 2 years, or uncontrolled autoimmune disease.
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.
Has a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
Has received prior allogeneic stem cell or solid organ transplant.
Received a live attenuated vaccine within 30 days.

What this trial measures

  • 3 months of progression-free survival (PFS) while on Pembrolizumab Monotherapy.3 months

    Number of patients who achieve PFS at the 3-month mark on pembrolizumab monotherapy. These patients will undergo radiographic assessments to evaluate progression-free survival (PFS).

  • 6 months of PFS while on Pembrolizumab Monotherapy6 months

    Number of patients in the de-escalation phase who have reached 6-month PFS while on pembrolizumab monotherapy.