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

GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To compare high-grade recurrence-free-survival between treated with gemcitabine with BCG (GemBCG) compared to those treated with BCG alone. SECONDARY OBJECTIVES: I. To compare the proportion of patients who remain high grade cancer free on initial post-treatment cystoscopic biopsies/transurethral resection of bladder tumor (TURBT) (week 13/month 3) between those treated with GemBCG compared to those treated with BCG alone. II. To compare the 6-month (Week 25) complete response rate and the complete response durability between patients treated with GemBCG compared to those treated with BCG alone among patients with pre-treatment CIS. III. To compare the time to recurrence of any-grade bladder cancer between patients treated with GemBCG compared those treated with BCG alone. IV. To compare the progression-free-survival between patients treated with GemBCG compared to those treated with BCG alone. V. To compare the cystectomy-free-survival between patients treated with GemBCG compared to those treated with BCG alone. VI. To compare the proportion of patients free from BCG-unresponsive NMIBC between those treated with GemBCG compared to those treated with BCG alone. VII. To determine the safety of and toxicity associated with GemBCG treatment relative to that of BCG treatment alone. EXPLORATORY OBJECTIVE: I. To collect tumor tissue/bladder biopsies, blood, and urine samples for biobanking that will enable future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive BCG intravesically over 2 hours once per week (QW) for 6 weeks. 2-6 weeks after completing endoscopic assessment, patients receive BCG over 2 hours QW for 3 weeks at month 3, 6 and 12 in the absence of disease progression or unacceptable toxicity. Patients undergo bladder biopsy, TURBT, cystoscopy, computed tomography (CT) scan/ magnetic resonance imaging (MRI) and blood and urine sample collection throughout the study. ARM B: Patients receive gemcitabe intravesically over 1 hour twice weekly on weeks 1 and 10 and once weekly on weeks 4 and 7. Patients also receive BCG intravesically over 2 hours QW on weeks 2, 3, 6, 8 and 9. 2-6 weeks after completing endoscopic assessment, patients receive gemcitable intravesically over 1 hour on week 1 and BCG intravesically over 2 hours on week 2-4 at month 3, 6 and 12 in the absence of disease progression or unacceptable toxicity. Patients undergo bladder biopsy, TURBT, cystoscopy, CT scan/MRI and blood and urine sample collection throughout the study. After completion of study treatment, patients are followed every 3 months for 2 years, then every 6 months for 3 years up to 5 years from randomization.

Conditions

• Recurrent Non-Muscle Invasive Bladder Carcinoma
• Stage 0a Bladder Cancer AJCC v8
• Stage I Bladder Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	BCG Solution	Given intravesically
PROCEDURE	Biopsy of Bladder	Undergo bladder biopsy
PROCEDURE	Cystoscopy	Undergo cystoscopy
PROCEDURE	Computed Tomography	Undergo CT Scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Biospecimen Collection	Undergo blood and urine sample collection
PROCEDURE	Transurethral Resection of Bladder Tumor	Undergo TURBT
DRUG	Gemcitabine	Given intravesically

Timeline

• Start date: 2025-07-17
• Primary completion: 2028-06-05
• Completion: 2028-12-05
• First posted: 2025-05-31
• Last updated: 2026-04-07

Locations

56 sites across 1 country: United States