Clinical Trial

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

Study acronym: RAD-VACCINE
Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-02-01; most recent amendment 2025-10-22.
Status change: Recruiting → Active, Not Recruiting 2025-10-22
Status change: Not Yet Recruiting → Recruiting 2022-02-15
Trial Details
NCT Number NCT05241340
Lead Sponsor The Methodist Hospital Research Institute
Collaborators: Pfizer
Conditions Urothelial Carcinoma Bladder
Enrollment 33 participants
Start Date 2022-02-15
Primary Completion 2025-08-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-24