Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy

This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immun

Trial Details

NCT ID
NCT07000084
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • BCG Solution
  • Biopsy of Bladder
  • Cystoscopy
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Biospecimen Collection
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
  • Irvine, California, United States|33.66946,-117.82311
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis/carcinoma in situ \[CIS…
  • Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes/variant histologies are allowe…
  • \* Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed
  • All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted).

For full eligibility, visit ClinicalTrials.gov.

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