A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer (NCT07414992) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer
United States44 participantsStarted 2026-05
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years at the time of informed consent
* ECOG 0-1
* Histologically confirmed diagnosis of urothelial carcinoma.
° Variant histology is acceptable if there is a predominant urothelial component. Any neuroendocrine / small cell components are excluded (Investigators are encouraged to discuss with study team and PI)
* Cystoscopically and radiographically confirmed cT2-4a cN0 cM0 disease per American Joint Committee on Cancer Staging Manual, 8th edition.
* Patients with cT4a disease invading into the prostatic stroma with no cystoscopic confirmation of muscle invasion are eligible.
* Clinically node-negative pelvis (cN0) on CT or MRI within 56 days: no pelvic lymph node ≥15 mm short-axis. Pelvic nodes 10-14 mm are permitted if not suspicious by GU radiology morphology; if deemed suspicious, biopsy or repeat imaging in 4-6 weeks must confirm cN0 prior to enrollment. PET may inform adjudication but is not required.
* Patients declines cisplatin-based therapy or is ineligible for cisplatin-based therapy based on any of the following criteria:
* Estimated or calculated creatinine clearance ≥ 30ml/min but \< 60 ml/min
* Grade 2 or above audiometric hearing loss (per CTCAE v5.0)
* Grade 2 or above peripheral neuropathy (per CTCAE v5.0)
* Availability of tumor specimen block or 20 unstained slides from diagnosis of muscle-invasive disease. Patients with fewer than 20 slides available may be enrolled after discussion with the Principal Invest…