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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

Study acronym: GAIN-BCG
StatusRecruiting
PhasePhase 3
Started2025-07-17
View on ClinicalTrials.gov ↗

Amendment history

2026-08-04
minor
Study Status, Contacts/Locations v12
Study sitescontacts updated at 1 of 58 sites
2026-07-01
minor
Study Status, Contacts/Locations v11
Study sites56→58
2026-06-01
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 56 sites
2026-04-06
minor
Study Status, Contacts/Locations v9
Study sites55→56
2026-03-02
minor
Study Status, Contacts/Locations v8
Study sites53→55
Show 7 earlier versions
2026-02-03
minor
Study Status, Contacts/Locations v7
Study sites52→53
2026-01-06
minor
Study Status, Contacts/Locations v6
Study sites50→52
2025-12-08
minor
Study Status, Contacts/Locations v5
Study sites44→50
2025-11-04
minor
Study Status, Contacts/Locations v4
Study sites42→44
2025-10-07
minor
Study Status, Contacts/Locations v3
Start date2025-06-05→2025-07-17
Study sites38→42
2025-09-02
minor
Study Status, Contacts/Locations v2
Study sites7→38
2025-06-27
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2028-06-05→confirmed 2025-06-05
Study sites0→7
2025-05-23
minor
Original filing
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.
Trial Details
NCT Number NCT07000084
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Non-Muscle Invasive Bladder Carcinoma, Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8
Enrollment 330 participants
Start Date 2025-07-17
Primary Completion 2028-06-05 (estimated)
Study Completion 2028-12-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-05