NCT07414992

A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer

Neoadjuvant STereotActic Body Radiotherapy and Cemiplimab With or Without Fianlimab for Cisplatin-Ineligible or Cisplatin-Declining Patients With Muscle-Invasive Bladder Cancer (NeoSTAR Bladder)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients will be assigned to neoadjuvant SBRT and cemiplimab (Cohort 1) until Cohort 1 completes accrual and then enrollment for Cohort 2 will begin with those patients receiving neoadjuvant SBRT plus cemiplimab and fianlimab.

Conditions

• Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
RADIATION	Stereotactic body radiotherapy	Stereotactic body radiotherapy (SBRT) Tumor-directed SBRT will be delivered in three once-daily 8 Gy fraction
DRUG	Cemiplimab	Cemiplimab will be delivered on day 1 of each cycle for a total of 4 cycles,
DRUG	Cemiplimab and Fianlimab	Within 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.
PROCEDURE	Radical cystectomy	Within 60 days of completing the 4 cycles of cemiplimab and fianlimab, patients will undergo radical cystectomy which is standard of care.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study