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Neoadjuvant Sasanlimab With Radiation as an in Situ Vaccine for Cisplatin-ineligible Muscle Invasive Bladder Cancer

Study acronym: RAD-VACCINE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Completion date: Aug 1, 2025 to Apr 1, 2027 · Site details revisedv4 Show 2 more changesShow less
    • Completion date: Aug 1, 2025 to Apr 1, 2027
    • Site details revised
  2. Primary completion date: Feb 20, 2024 to Aug 1, 2025 Completion date: Feb 20, 2025 to Aug 1, 2025v3 Show 1 more changeShow less
    • Completion date: Feb 20, 2025 to Aug 1, 2025
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Feb 20, 2022 to Feb 15, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 20, 2022 to Feb 15, 2022
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective, single-institution, single-arm, phase II clinical trial that tests a novel strategy of neoadjuvant Sasanlimab, an immune checkpoint inhibitor (ICI), in combination with stereotactic body radiation therapy as an in-situ vaccination in patients, who are ineligible to receive cisplatin-based chemotherapy and undergoing radical cystectomy for muscle-invasive bladder cancer.
Trial Details
NCT Number NCT05241340
Lead Sponsor The Methodist Hospital Research Institute
Collaborators: Pfizer
Conditions Urothelial Carcinoma Bladder
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov