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Study identifier: NCT07000084 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Recurrent Non-Muscle Invasive Bladder Carcinoma · Stage 0a Bladder Cancer AJCC v8 · Stage I Bladder Cancer AJCC v8  ·  Sponsor: Alliance for Clinical Trials in Oncology

PhasePhase 3
Planned participants330
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Aishwarya Vijendran  ·  (773) 702-9171  ·  guprotocols@alliancenctn.org

Always discuss trial participation with your own doctor first.

Locations (58)

University of Alabama at Birmingham Cancer CenterBirmingham, Alabama, United StatesRecruiting
Fairbanks Memorial HospitalFairbanks, Alaska, United StatesRecruiting
Banner MD Anderson Cancer CenterGilbert, Arizona, United StatesRecruiting
Mayo Clinic Hospital in ArizonaPhoenix, Arizona, United StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California, United StatesRecruiting
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United StatesRecruiting
Sibley Memorial HospitalWashington D.C., District of Columbia, United StatesRecruiting
UF Health Cancer Institute - GainesvilleGainesville, Florida, United StatesRecruiting
Mayo Clinic in FloridaJacksonville, Florida, United StatesRecruiting
Kootenai Health - Coeur d'AleneCoeur d'Alene, Idaho, United StatesRecruiting
Kootenai Clinic Cancer Services - Post FallsPost Falls, Idaho, United StatesRecruiting
Kootenai Clinic Cancer Services - SandpointSandpoint, Idaho, United StatesRecruiting

+ 46 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07000084