NCT07000084|RecruitingPhase 3

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

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

A032303NCI-2025-02655

Study Type

interventional

Target

330

Locations

1 country

Sites

Timeline

RegisteredMay 2025

StartedJul 2025

CompletionDec 2028

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

330

participants targeted

Target at P50-P75 for phase_3

Timeline

31mo left

Started Jul 2025

Typical duration for phase_3

Geographic Reach

1 country

55 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.4 years study duration

Study Progress24%

Jul 2025Dec 2028

First Submitted

Initial submission to the registry

May 23, 2025

Completed

8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed

2 months until next milestone

Study Start

First participant enrolled

July 17, 2025

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2028

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2028

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

May 23, 2025

Last Update Submit

March 2, 2026

Conditions

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

Outcome Measures

Primary Outcomes (1)

High Grade Recurrence-free survival (HG-RFS)
HG-RFS will be calculated from randomization until the detection of a high-grade bladder cancer recurrence (biopsy proven intravesical recurrence or distant metastasis), cystectomy, or death, whichever occurs first. Patients who are alive and without documented high-grade recurrence will be censored at the time of last disease evaluation. HG-RFS will be compared between the two study arms using a stratified log-rank test. The treatment effect will be estimated with a hazard ratio (HR) and corresponding 95% confidence interval obtained from a stratified Cox model with treatment group (
Up to 5 years

Secondary Outcomes (8)

High-grade cancer free at 3 months
at 3 months
6-month Complete Response
At 6 months
Durability of Response
Up to 5 years
Recurrence-free survival
Up to 5 years
Progression-free survival
up to 5 years
+3 more secondary outcomes

Study Arms (2)

Arm A (BCG)

ACTIVE COMPARATOR

Patients receive BCG intravesically over 2 hours 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, CT scan/MRI and blood and urine sample collection throughout the study.

Biological: BCG SolutionProcedure: Biopsy of BladderProcedure: CystoscopyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Biospecimen CollectionProcedure: Transurethral Resection of Bladder Tumor

Arm B (BCG and gemcitabine)

EXPERIMENTAL

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.