Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07579195
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Muscle Invasive Bladder Carcinoma
  • Stage III Bladder Cancer AJCC v8
  • Stage IV Bladder Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Volume Modulated Arc Therapy — RADIATION
    Undergo VMAT
  • Cisplatin — DRUG
    Given IV
  • Gemcitabine — DRUG
    Given IV
  • Fluorouracil — DRUG
    Given fluorouracil
  • Mitomycin — DRUG
    Given mitomycin
  • Radical Cystectomy — PROCEDURE
    Undergo radical cystectomy
  • Pelvic Lymphadenectomy — PROCEDURE
    Undergo pelvic lymph node dissection
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT
  • Computed Tomography — PROCEDURE
    Undergo CT and/or PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Transurethral Resection of Bladder Tumor — PROCEDURE
    Undergo TURBT
  • Cystoscopy — PROCEDURE
    Undergo cystoscopy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and urine samples
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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 from untreated local disease, and inform future treatment strategies for patients with advanced bladder cancer.

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Local consolidative therapy
    Following a complete re-TURBT, participants with residual bladder disease will receive either concurrent chemoradiation (IMRT/VMAT, 55 Gy in 20 fractions) to bladder +/- pelvic nodes or cystectomy, based on shared decision-making. For patients with a clinical complete response, bladder-directed consolidation is encouraged but optional. Patients with disease outside the true pelvis will receive metastasis-directed therapy (preferably SBRT) following primary chemoradiation to all site of metastasis. Participants then proceed to observation or maintenance pembrolizumab until progression, unacceptable toxicity, or clinical discretion. The study includes longitudinal imaging, cystoscopy, biospecimen collection, and quality-of-life assessments.

Primary Outcome Measure

Completion rate of protocol-defined treatment (feasibility) [ Time Frame: Up to 18 months from start of enfortumab vedotin (EV) + pembrolizumab ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
T. Martin Ma, MD, PhD
[email protected]
206-606-7318
T. Martin Ma, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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