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.
Single group
Stereotactic body radiotherapy
RadiationStereotactic body radiotherapy (SBRT) Tumor-directed SBRT will be delivered in three once-daily 8 Gy fraction
Cemiplimab
DrugCemiplimab will be delivered on day 1 of each cycle for a total of 4 cycles,
Cemiplimab and Fianlimab
DrugWithin 96 hours (i.e., 4 days) of completing the 3rd SBRT treatment, patients will receive their first cycle of cemiplimab and fianlimab in the morning or early afternoon. Patients will receive a total of 4 cycles of cemiplimab and fianlimab with each cycle lasting 3 weeks and treatment occurring during weeks 0, 3, 6, and 9. Cemiplimab and fianlimab infusions in the morning or early afternoon will be encouraged.
Radical cystectomy
Procedure/SurgeryWithin 60 days of completing the 4 cycles of cemiplimab and fianlimab, patients will undergo radical cystectomy which is standard of care.
Rate of pathologic downstaging
Pathologic downstaging will be defined as lack of muscle invasive carcinoma (\<ypT2) and the absence of lymph node metastasis (ypN0) in the final cystectomy specimen after radical cystectomy.
Pathologic complete response
Is defined as the absence of carcinoma (ypT0) and the absence of lymph node metastasis (ypN0) in the final cystectomy and regional lymph node specimens.
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Memorial Sloan Kettering Cancer Center
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
