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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: Clinical Trial Phase 1 study, sponsored by University of Washington.
NCT07579195 is a Phase 1 study that has not yet begun recruiting, run by University of Washington. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Feasibility will be assessed through the completion rate of protocol-defined treatment. Primary endpoint is met if the completion rate of protocol-defined treatment is \> 70%. Descriptive statistics will be provided.
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 |
What is known before NCT07579195 opens enrollment
NCT07579195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT07579195 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07579195's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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