NCT07183319 Circulating Tumor DNA Response In Urothelial Cancer
| NCT ID | NCT07183319 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Oklahoma |
| Condition | Urothelial Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-01-19 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-01-19 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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 a. Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy. * 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 Criteria: * 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.
Contact & Investigator
Adanma Ayanambakkam, MD
PRINCIPAL INVESTIGATOR
University of Oklahoma
Frequently Asked Questions
Who can join the NCT07183319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Urothelial Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07183319 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07183319 currently recruiting?
Yes, NCT07183319 is actively recruiting participants. Contact the research team at SCC-IIT-Office@ouhsc.edu for enrollment information.
Where is the NCT07183319 trial being conducted?
This trial is being conducted at Oklahoma City, United States.
Who is sponsoring the NCT07183319 clinical trial?
NCT07183319 is sponsored by University of Oklahoma. The principal investigator is Adanma Ayanambakkam, MD at University of Oklahoma. The trial plans to enroll 30 participants.