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Bladder cancer combo trial: could adding chemo to BCG keep tumors away?

NCT ID NCT07000084

Disease control Sponsor: Alliance for Clinical Trials in Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether adding the chemotherapy drug gemcitabine to standard BCG therapy can better prevent high-grade bladder cancer from coming back. About 330 people with recurrent non-muscle invasive bladder cancer will receive either BCG alone or BCG plus gemcitabine, both given directly into the bladder. The main goal is to see how long participants stay cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gemcitabine (chemotherapy) and BCG (immune-stimulating bacteria solution)
What this could lead to
If it works, this could offer a more effective treatment option for people with recurrent high-grade bladder cancer, potentially reducing the chance of the cancer coming back.
What could go wrong
This is a phase 3 trial, but it's still experimental. Adding gemcitabine may increase side effects, and it's not yet known if it will be better than BCG alone. Results may not apply to all bladder cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. \* Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed * All visible papillary lesions must be macroscopically resected by TURBT within 90 days of randomization. (Residual CIS is permitted). \* If the treating urologist did not perform the TURBT, the treating urologist must perform a cystoscopy within 45 days prior to randomization to confirm the absence of visible papillary disease * 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. \* The radiographic imaging includes a CT Scan or MRI of the abdomen/pelvis with intravenous contrast, with a CT or MRI urogram preferred. If a patient is unable to receive intravenous contrast due to renal function or allergy, then either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable * 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)

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent non-muscle invasive bladder carcinoma Stage 0A bladder cancer ajcc V8 Stage I bladder cancer ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    58 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Benefis Helena Specialty Center

    RECRUITING

    Helena, Montana, 59601, United States

    Contact Email: •••••@•••••

  • Benefis Sletten Cancer Institute

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Billings Clinic Cancer Center

    RECRUITING

    Billings, Montana, 59101, United States

    Contact Email: •••••@•••••

  • Billings Clinic-Cody

    RECRUITING

    Cody, Wyoming, 82414, United States

    Contact Email: •••••@•••••

  • Bozeman Health Deaconess Hospital

    RECRUITING

    Bozeman, Montana, 59715, United States

    Contact Email: •••••@•••••

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Community Hospital of Anaconda

    RECRUITING

    Anaconda, Montana, 59711, United States

    Contact Email: •••••@•••••

  • Community Medical Center

    RECRUITING

    Missoula, Montana, 59804, United States

    Contact Email: •••••@•••••

  • FMH James M Stockman Cancer Institute

    RECRUITING

    Frederick, Maryland, 21702, United States

  • Fairbanks Memorial Hospital

    RECRUITING

    Fairbanks, Alaska, 99701, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fox Chase Cancer Center-Rockledge

    RECRUITING

    Rockledge, Pennsylvania, 19046, United States

  • Geisinger Cancer Center Dickson City

    RECRUITING

    Dickson City, Pennsylvania, 18519, United States

    Contact Email: •••••@•••••

  • Geisinger Medical Center

    RECRUITING

    Danville, Pennsylvania, 17822, United States

    Contact Email: •••••@•••••

  • Geisinger Medical Oncology-Lewisburg

    RECRUITING

    Lewisburg, Pennsylvania, 17837, United States

    Contact Email: •••••@•••••

  • Geisinger Wyoming Valley/Henry Cancer Center

    RECRUITING

    Wilkes-Barre, Pennsylvania, 18711, United States

    Contact Email: •••••@•••••

  • Great Falls Clinic

    RECRUITING

    Great Falls, Montana, 59405, United States

    Contact Email: •••••@•••••

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hi-Line Sletten Cancer Center

    RECRUITING

    Havre, Montana, 59501, United States

  • IU Health Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

    Contact Email: •••••@•••••

  • IU Health North Hospital

    RECRUITING

    Carmel, Indiana, 46032, United States

    Contact Email: •••••@•••••

  • IU Health West Hospital

    RECRUITING

    Avon, Indiana, 46123, United States

    Contact Email: •••••@•••••

  • Indiana University/Melvin and Bren Simon Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

    Contact Email: •••••@•••••

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kootenai Clinic Cancer Services - Post Falls

    RECRUITING

    Post Falls, Idaho, 83854, United States

    Contact Email: •••••@•••••

  • Kootenai Clinic Cancer Services - Sandpoint

    RECRUITING

    Sandpoint, Idaho, 83864, United States

    Contact Email: •••••@•••••

  • Kootenai Health - Coeur d'Alene

    RECRUITING

    Coeur d'Alene, Idaho, 83814, United States

    Contact Email: •••••@•••••

  • Lahey Clinic

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Lahey Clinic Peabody

    RECRUITING

    Peabody, Massachusetts, 01960, United States

  • Logan Health Medical Center

    RECRUITING

    Kalispell, Montana, 59901, United States

    Contact Email: •••••@•••••

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb

    RECRUITING

    Melrose Park, Illinois, 60160, United States

  • Mary Bird Perkins Cancer Center - Metairie

    RECRUITING

    Metairie, Louisiana, 70002, United States

  • Mayo Clinic Hospital in Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Hospital of Laramie County

    RECRUITING

    Cheyenne, Wyoming, 82001, United States

  • Memorial Sloan Kettering Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    RECRUITING

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    RECRUITING

    Harrison, New York, 10604, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Ralph H Johnson VA Medical Center

    RECRUITING

    Charleston, South Carolina, 29401, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Sibley Memorial Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    RECRUITING

    Irvine, California, 92612, United States

    Contact Email: •••••@•••••

  • UF Health Cancer Institute - Gainesville

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Alabama at Birmingham Cancer Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Illinois

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

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Other studies related to the condition(s) this trial covers.