Actively Recruiting
Circulating Tumor DNA Response In Urothelial Cancer
Led by University of Oklahoma · Updated on 2026-02-02
30
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
N
Natera, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Circulating Tumor DNA Response In Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
- Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has shown clear progression since radiation.
- Eligible to receive cisplatin- or carboplatin-containing chemotherapy.
- Archival tumor tissue or biopsy of metastatic urothelial carcinoma must be available for tumor-informed ctDNA analysis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
- Adequate hematologic and organ function (Hemoglobin ≥ 8.0 g/dL; Absolute Neutrophil Count ≥ 1.5x10^9 cells/L; Creatinine Clearance ~30 mL/min; total bilirubin ≤ 1.5 mg/dL; ALT and AST within normal limits).
You will not qualify if you...
- Previously received enfortumab, vedotin, or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates.
- Received PD-(L)-1 inhibitors for any malignancy within 12 months.
- Received anti-cancer treatment not completed within 28 days prior to study start.
- Have uncontrolled diabetes or grade III or higher peripheral neuropathy.
- Estimated life expectancy less than 12 weeks.
- Untreated central nervous system metastases.
- Ongoing significant toxicity from prior treatment not resolved to Grade 1 or baseline.
- Currently receiving systemic antimicrobial treatment for active infection (except routine prophylaxis).
- Known active hepatitis B, hepatitis C, or HIV infection.
- History of another invasive malignancy requiring treatment within 3 years or residual disease from previous malignancy (except localized prostate or certain skin cancers).
- History of recent serious cardiovascular events within 6 months.
- Received radiotherapy or major surgery within 2 weeks before study.
- Known severe hypersensitivity to Enfortumab Vedotin excipients.
- Active keratitis or corneal ulcerations.
- Autoimmune disease requiring systemic immunosuppressive treatment in past 2 years or uncontrolled autoimmune disease.
- Prior systemic therapy for locally advanced or metastatic urothelial carcinoma except certain allowed cases.
- History of pulmonary fibrosis, pneumonitis, or evidence of active pneumonitis on screening chest CT.
- Prior allogeneic stem cell or solid organ transplant.
- Received live attenuated vaccine within 30 days.
AI-Screening
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Trial Site Locations
Total: 1 location
1
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73117
Actively Recruiting
Research Team
L
Lead Onco Nurse
CONTACT
A
Adanma Ayanambakkam, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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