OncoMatch/Clinical Trials/NCT07000084
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
Is NCT07000084 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including BCG Solution and Gemcitabine for recurrent non-muscle invasive bladder carcinoma.
Treatment: BCG Solution · Gemcitabine — 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 immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage 0A, I, TIS (AJCC v8)
Grade: high grade
high grade Ta, high grade T1, or Tis (Tis/carcinoma in situ [CIS] only disease); Patient must not have any prior history or current evidence of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma
Prior therapy
Must have received: BCG therapy — induction and/or maintenance
Patients must have BCG-Exposed non muscle invasive bladder carcinoma (NMIBC), defined as recurrent high grade NMIBC within 24 months of last BCG exposure but not meeting the definition of BCG unresponsive disease
Cannot have received: BCG-unresponsive disease
Exception: Patient who previously met the definition of BCG unresponsive NMIBC but no longer currently meets unresponsive criteria may still enroll if re-treatment with BCG is reasonable
Patient must not have BCG-unresponsive NMIBC
Cannot have received: intolerance to BCG or any other intravesical therapies
Patients must not have a history of intolerance to BCG (ie needing to stop BCG induction or maintenance due to toxicity) or intolerance to any other intravesical therapies
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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