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NCT07579195 · ClinicalTrials.gov registry record · Phase 1
Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial
A Phase 1 study, sponsored by University of Washington.
- Not yet
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT07579195 is a Phase 1 study that has not yet begun recruiting, run by University of Washington. The registered enrollment target is 12 participants.
The verdict
NCT07579195, a Phase 1 study, has not yet begun recruiting, sponsored by University of Washington.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This phase I/II clinical trial is evaluating a novel treatment strategy for patients with advanced bladder cancer that is unresectable, has spread to nearby lymph nodes or a limited number of distant sites (oligometastatic disease), and has responded to initial treatment with enfortumab vedotin and pembrolizumab. Although this combination has significantly improved outcomes compared to traditional chemotherapy, many patients are left with residual cancer in the bladder or other sites, and there is currently no established standard approach for managing this remaining disease or determining the optimal duration of systemic therapy. Prolonged treatment can lead to cumulative side effects and negatively impact quality of life. This study investigates whether adding consolidative treatment-such as radiation therapy to the bladder and metastatic sites or surgical removal of the bladder (radical cystectomy)-can safely eliminate residual disease and delay cancer progression. Radiation therapy uses high-energy x-rays to precisely target and destroy cancer cells while minimizing exposure to surrounding normal tissues. In selected patients, surgery may be used to remove remaining tumor in the bladder. Targeted radiation techniques, such as stereotactic body radiation therapy (SBRT), may also be used to treat small metastatic sites. This approach may allow for safe discontinuation of systemic therapy, potentially reducing long-term treatment-related side effects. A key component of this trial is the integration of biomarker testing using circulating tumor DNA (ctDNA) from blood and urine tumor DNA (utDNA). These tests detect small amounts of tumor-derived genetic material and may help identify patients most likely to benefit from consolidative treatment, as well as guide decisions about ongoing therapy. By combining response to systemic therapy with personalized local treatment and biomarker-driven monitoring, this study aims to improve cancer control, reduce complications f
Interventions
- DRUG Cisplatin
- DRUG Fluorouracil
- DRUG Gemcitabine
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION Volume Modulated Arc Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07579195
The ClinicalTrials.gov registry entry for NCT07579195 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT07579195 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07579195 about?
NCT07579195 is a clinical study titled "Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial". This phase I/II clinical trial is evaluating a novel treatment strategy for patients with advanced bladder cancer that is unresectable, has spread to nearby lymph nodes or a limited number of distant sites (oligometastatic disease), and has responded to initial treatment with enfortumab vedotin and ...
What is the current status of trial NCT07579195?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-07-01. Estimated completion is 2029-12-31.
What interventions are being tested in trial NCT07579195?
The interventions under investigation include: Cisplatin (DRUG), Fluorouracil (DRUG), Gemcitabine (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Volume Modulated Arc Therapy (RADIATION).
Who is sponsoring clinical trial NCT07579195?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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