S2427: Single Arm Phase II Study of Bladder Preservation with Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients with Muscle Invasive Bladder Cancer (BRIGHT)

Clinical Trial Details

 The purpose of this study is to test the good and bad effects of combining the study drug pembrolizumab with radiation therapy in people whose bladder cancer has shrunk or cannot be found after earlier treatment. The study doctors hope to learn if the study drug controls the cancer so patients don’t need to have their bladder removed.

Pembrolizumab is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). Pembrolizumab is approved by the FDA to treat other cancers. 

Study participants will receive 20 radiation therapy treatments and pembrolizumab administered intravenously through a vein in the arm for up to 1 year. Participants will also come into the clinic for study visits every 6 months until 2 years after treatment and then once a year for the remainder of the study until 5 years after treatment.

Total study participation will last approximately 5 years.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have confirmed of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder.
  2. Participants must not have the presence of small cells, neuroendocrine carcinoma, or plasmacytoid variants on any pathology

Detailed eligibility will be reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)


646-962-2072
guonc@med.cornell.edu

Queens

Contact(s)

Charlotte Fong
718-660-1716
ccf4001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2511029591

ClinicalTrials.gov:

NCT07061964

Sponsor:

S2427

Status

Not Yet Recruiting

Age Group

Adult

Sponsor