The researchers are doing this study to find out whether stereotactic body radiation therapy (SBRT) in combination with immunotherapy (cemiplimab with or without fianlimab) before cystectomy is an effective and safe treatment for people with muscle-invasive bladder cancer (MIBC).
Age ≥ 18 years at the time of informed consent
ECOG 0-1
Histologically confirmed diagnosis of urothelial carcinoma.
Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease per American Joint Committee on Cancer Staging Manual, 8th edition.
Evidence of metastatic disease on standard staging CT and/or MR imaging
Evidence of nodal metastasis (cN+), defined as any pelvic node ≥15 mm short-axis on CT/MRI or biopsy-proven nodal disease of any size.
Prior systemic chemotherapy or non-BCG immunotherapy (e.g., T cell co-stimulation or targeting of immune checkpoint pathways with anti-PD-1, anti-PD-L1, anti-LAG-3, anti-PD-L2, anti-CTLA-4, anti-CD137, IL-15 superagonist, or other medicines specifically targeting T cells other than prior IL-2 therapy) for the treatment of bladder cancer
Prior therapy with intravesical BCG within 6 weeks of treatment.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Regeneron Pharmaceuticals
Collaborator