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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07414992
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Bladder Urothelial Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation Therapy and Cemiplimab
    Stereotactic body radiotherapy (SBRT) and cemiplimab
  • Experimental: Radiation Therapy and Cemiplimab With Fianlimab
    Stereotactic body radiotherapy (SBRT) and cemiplimab with Fianlimab

Primary Outcome Measure

Rate of pathologic downstaging [ Time Frame: 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Daniel Gorovets, MD
212-639-3983
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Daniel Gorovets, MD
212-639-3983
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Daniel Gorovets, MD
212-639-3983
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Daniel Gorovets, MD
212-639-3983
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Daniel Gorovets, MD
212-639-3983
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Daniel Gorovets, MD
212-639-3983
Matthew Mcmillan, MD
631-212-6399
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Daniel Gorovets, MD
212-639-3983

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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