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

This pilot feasibility 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 determin

Trial Details

NCT ID
NCT07579195
Phase
PHASE1 / PHASE2
Sponsor
University of Washington
Status
RECRUITING
Cancer Type
Bladder Cancer
Interventions
  • Intensity-Modulated Radiation Therapy
  • Volume Modulated Arc Therapy
  • Radiosensitizing Agent
  • Radical Cystectomy
  • Pelvic Lymphadenectomy
  • Stereotactic Body Radiation Therapy
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Age \>= 18 at the time of screening
  • Ability to understand and willingness to sign a written informed consent document
  • Histopathologically confirmed cTxN1-3M0, cTxNxM1 or cT4bNxM0 muscle invasive bladder cancer at initial diagnosis
  • Achieved a radiographic complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 …

For full eligibility, visit ClinicalTrials.gov.

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