Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer c

Trial Details

NCT ID
NCT07061964
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Cystoscopy
  • Magnetic Resonance Imaging
  • Pembrolizumab
  • Photon Beam Radiation Therapy
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Fayetteville, Arkansas, United States|36.06258,-94.15743
  • Rogers, Arkansas, United States|36.33202,-94.11854

Key Eligibility Criteria

  • Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neo…
  • Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0
  • Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall …
  • NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT

For full eligibility, visit ClinicalTrials.gov.

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