Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial

This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping

Trial Details

NCT ID
NCT06770582
Phase
PHASE2
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Biospecimen Collection
  • Cisplatin
  • Computed Tomography
  • Fluorouracil
  • Gemcitabine
  • Magnetic Resonance Imaging
Locations (sample)
  • Fayetteville, Arkansas, United States|36.06258,-94.15743
  • Rogers, Arkansas, United States|36.33202,-94.11854
  • Springdale, Arkansas, United States|36.18674,-94.12881
  • Bakersfield, California, United States|35.37329,-119.01871
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evid…
  • NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible
  • High grade T1 disease history that must meet at least ONE of the three criteria below:
  • Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+/- focal carcinoma in situ \[CIS\]) in the bladder following initial …

For full eligibility, visit ClinicalTrials.gov.

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