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Testing Gemcitabine with BCG for Recurrent Non-Muscle Invasive Bladder Cancer

This study is looking at whether adding an anti-cancer drug called gemcitabine to the usual treatment, BCG (Bacillus Calmette Guerin), works better for people whose non-muscle invasive bladder cancer (NMIBC) has returned. Gemcitabine is a chemotherapy drug that helps kill cancer cells by stopping them from making DNA. BCG is a solution placed directly into the bladder that uses bacteria to stimulate your immune system to fight cancer. Researchers want to see if combining gemcitabine with BCG can kill more cancer cells. You may be able to join if you are 18 or older, have recurrent high-grade non-muscle invasive bladder cancer, and meet other specific criteria. The main goal is to see how long people stay free from high-grade cancer recurrence, measured for up to 5 years. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 330 participants. It compares two groups: one receiving gemcitabine with BCG, and another receiving BCG alone.
What's involved
Participants will undergo procedures such as bladder biopsy, cystoscopy (a scope to look inside the bladder), CT scans, and MRI scans. The study involves receiving BCG solution directly into the bladder.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study, high-grade recurrence-free survival, will be measured for up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Alliance for Clinical Trials in Oncology
~330 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:BCG SolutionBiopsy of BladderCystoscopyComputed TomographyMagnetic Resonance ImagingBiospecimen Collection

At a glance

Recruiting sites
58 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
High Grade Recurrence-free survival (HG-RFS)
Measured over Up to 5 years

Conditions

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

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NCT07000084

Where you'd take part

This study runs at 58 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Banner MD Anderson Cancer Center

    Gilbert, Arizonastudy coordinator listed

    Recruiting

  • Benefis Helena Specialty Center

    Helena, Montanastudy coordinator listed

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montanastudy coordinator listed

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montanastudy coordinator listed

    Recruiting

  • Billings Clinic-Cody

    Cody, Wyomingstudy coordinator listed

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montanastudy coordinator listed

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montanastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Eugene Pietzak, MD · STUDY_CHAIR · Alliance for Clinical Trials in Oncology

Who to contact

Aishwarya Vijendran
[email protected]
(773) 702-9171
Email the study team

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Eligibility criteria

Inclusion

Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis/carcinoma in situ \[CIS\] only disease) within 120 days prior to randomization
Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes/variant histologies are allowed so long as there is a predominantly urothelial component.
All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted).
All patients with high grade T1 must undergo a restaging TURBT within 90 days of randomization. Patients who undergo a restaging TURBT that shows no residual cancer in the specimen are still eligible for trial based on prior TURBT
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
Note: Up to 26 months from the last BCG instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by positive cytology, imaging, or cystoscopy) within 24 months of last exposure to BCG.
Note: A patient who previously met the definition of BCG unresponsive NMIBC but no longer currently meets unresponsive criteria may still enroll in this trial so long as the treating urologist believes re-treatment with BCG is a reasonable treatment option for that patient.
BCG-exposed NMIBC criteria is defined as:
Any high grade NMIBC recurrence within 24 months of induction only BCG, or
A high grade papillary NMIBC (Ta/T1) recurrence between 6-24 months of last exposure to induction + maintenance BCG, or
A high-grade CIS (with or without Ta/T1 papillary disease) recurrence within 12-24 months of last exposure to induction + maintenance BCG.
Patient must not have BCG-unresponsive NMIBC, defined as:
Persistent or recurrent high-grade papillary NMIBC (Ta/T1) \< 6 months of "adequate" BCG, or
A high-grade CIS (with or without Ta/T1 papillary disease) recurrence \< 12 months of "adequate" BCG, or
A high grade T1 recurrence at the first 3-month assessment from induction BCG
"Adequate" BCG is defined as ≥5 of 6 doses of induction BCG therapy with either
≥ 2 of 3 doses of maintenance BCG, or
≥ 2 of planned 6 instillations of repeat induction BCG given within a 6 month time period
More than one prior induction course of BCG and/or prior maintenance BCG is allowed so long as the patient does not currently met the definition of BCG unresponsive disease
Prior treatment with any intravesical chemotherapy (both perioperative and induction course) for NMIBC is allowed, including gemcitabine either alone or in combination (ie. gemcitabine plus docetaxel) or gemcitabine delivered through a intravesical delivery system (ie. TAR-200)
Prior treatment with any systemic or intravesical agents for NMIBC is allowed, regardless of whether it is given either alone or in prior combination with BCG (ie. Prior treatment with pembrolizumab, other immune checkpoint inhibitors, nadofaragene firadenovec, nogapendekin alfa inbakicept, cretostimogene grenadenorepvec, etc. are all allowed)
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
Patients must not have compromised bladder function such that they are unlikely to tolerate further intravesical therapies
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 as assessed on radiographic imaging obtained within 120 days prior to randomization.
Patients with a history of upper tract urothelial carcinoma are allowed so long as they had localized non-muscle invasive (Ta, T1, Tis) that has been definitively treated with surgery (nephroureterectomy or ureterectomy) with at least one post-treatment disease assessment imaging study that demonstrates no evidence of residual upper tract disease
Patients with a history of, or current evidence of, non-invasive (Ta/Tis) urothelial carcinoma of the prostatic urethra are eligible so long as a transurethral resection of prostate (TURP) is performed before enrollment and there is prostatic glandular tissue without evidence of lamina propria invasion or prostatic stromal invasion
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Age ≥ 18 years
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Not pregnant and not nursing, Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
has achieved menarche at some point
has not undergone a hysterectomy or bilateral oophorectomy
has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

What this trial measures

  • High Grade Recurrence-free survival (HG-RFS)Up to 5 years

    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 (