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Radiation + Cemiplimab ± Fianlimab for Bladder Cancer

Not yet recruiting at 6 trial locations
DG
Overseen ByDaniel Gorovets, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must not be taking: Immunosuppressants, Live vaccines
Disqualifiers: Metastatic disease, Autoimmune disease, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

DG

Daniel Gorovets, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

My kidney function is moderately reduced but not severely impaired.
My bladder cancer is stage T2-T4a, has not spread to lymph nodes or other organs.
I am 18 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Immunotherapy Treatment

Participants receive stereotactic body radiotherapy (SBRT) and cemiplimab, with or without fianlimab, as neoadjuvant treatment before cystectomy

6-8 weeks

Cystectomy

Participants undergo radical cystectomy to remove the bladder and surrounding tissues

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pathologic downstaging and complete response

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cemiplimab
  • Fianlimab
  • Stereotactic body radiotherapy

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Radiation Therapy and Cemiplimab With FianlimabExperimental Treatment3 Interventions
Group II: Radiation Therapy and CemiplimabExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
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Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

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George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

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