drugset / Trial / NCT05241340

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

NCT05241340

Phase 2 Active not recruiting 33 enrolled The Methodist Hospital Research Institute Pfizer · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-02-15
Primary completion
2025-08-01
Completion
2027-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sasanlimab Monoclonal antibody 300 mg Subcutaneous