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Radiation Therapy Combined with Immunotherapy Before Radical Cystectomy in Locally Advanced Bladder Cancer: A
Sebastian C Schmid1, Matthias Jahnen2, Kilian Schiller3
1Department of Urology, School of Medicine and Health, TUM University Hospital, Technical University of Munich, Munich, Germany; Urologie Trudering, Munich, Germany.
European Urology Oncology
|February 26, 2026
Summary
This study shows neoadjuvant radioimmunotherapy is feasible and safe for advanced bladder cancer before surgery. It met its primary endpoint, demonstrating a high completion rate and promising pathological response rates.
Area of Science:
- Oncology
- Immunotherapy
- Radiation Oncology
Background:
- Locally advanced bladder cancer carries a poor prognosis despite surgery.
- Neoadjuvant immunotherapy shows promise, potentially synergizing with radiation therapy.
Purpose of the Study:
- To evaluate the feasibility, safety, and efficacy of neoadjuvant radioimmunotherapy before radical cystectomy in locally advanced bladder cancer.
- This is the first prospective trial to assess this combined treatment approach.
Main Methods:
- Prospective, multicenter phase 2 trial.
- Patients received nivolumab plus pelvic radiotherapy followed by radical cystectomy.
- Feasibility was defined as a >70% completed treatment rate.
Main Results:
- The trial met its primary endpoint with an 87% treatment completion rate.
- Pathological response rates were 39% (ypT0 ypN0), 58% (≤ypT1 ypN0), and 74% (≤ypT2 ypN0).
- 55% experienced immune-related adverse events; 33% had grade 3/4 events, with no treatment-related deaths.
Conclusions:
- Neoadjuvant radioimmunotherapy is feasible and safe in this patient population.
- The findings support further investigation in a randomized setting.
