Recruiting
Phase 3

Gemcitabine vs. BCG

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT07000084

Conditions

Recurrent Non-Muscle Invasive Bladder Carcinoma

Stage 0a Bladder Cancer AJCC v8

Stage I Bladder Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BCG Solution

Biopsy of Bladder

Cystoscopy

Computed Tomography

Magnetic Resonance Imaging

Study Details

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.

Conditions

Recurrent Non-Muscle Invasive Bladder Carcinoma

Stage 0a Bladder Cancer AJCC v8

Stage I Bladder Cancer AJCC v8

Study ID

NCT07000084

Start date

Jul 17, 2025

Status verified date

Aug, 2026

Completion date

Dec 5, 2028

Anticipated

Primary completion date

Jun 5, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

330 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A (BCG)

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.

experimental: Arm B (BCG and gemcitabine)

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.

Interventions

BCG Solution

Given intravesically

Biopsy of Bladder

Undergo bladder biopsy

Cystoscopy

Undergo cystoscopy

Computed Tomography

Undergo CT Scan

Magnetic Resonance Imaging

Undergo MRI

Biospecimen Collection

Undergo blood and urine sample collection

Transurethral Resection of Bladder Tumor

Undergo TURBT

Gemcitabine

Given intravesically

Primary outcome measure

  • High Grade Recurrence-free survival (HG-RFS) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Aishwarya Vijendran

(773) 702-9171guprotocols@alliancenctn.org

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

gingerreeves@uabmc.edu

Principal Investigator:

Charles C. Peyton

Fairbanks Memorial Hospital

Recruiting

Fairbanks, Alaska, United States, 99701

Contacts

Site Public Contact

907-458-3043Veronica.Stevenson@foundationhealth.org

Principal Investigator:

John M. Schallenkamp

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Site Public Contact

602-747-9738

Principal Investigator:

Chinedu Mmeje

Mayo Clinic Hospital in Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Mark D. Tyson

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Michael Daneshvar

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Michael Daneshvar

Sibley Memorial Hospital

Recruiting

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

Contacts

Site Public Contact

202-243-2373jquiver1@jhmi.edu

Principal Investigator:

Max Kates

UF Health Cancer Institute - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Site Public Contact

352-273-8010

Principal Investigator:

Paul L. Crispen

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Mark D. Tyson

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301cancer@northwestern.edu

Principal Investigator:

Joshua J. Meeks

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Daniel Moreira

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Michael E. Woods

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Recruiting

Melrose Park, Illinois, United States, 60160

Contacts

Site Public Contact

708-450-4554

Principal Investigator:

Michael E. Woods

IU Health West Hospital

Recruiting

Avon, Indiana, United States, 46123

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Hristos Kaimakliotis

IU Health North Hospital

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Hristos Kaimakliotis

Indiana University/Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Hristos Kaimakliotis

IU Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Hristos Kaimakliotis

Mary Bird Perkins Cancer Center - Metairie

Recruiting

Metairie, Louisiana, United States, 70002

Contacts

Site Public Contact

504-584-6990

Principal Investigator:

Scott E. Delacroix

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Site Public Contact

410-955-8804jhcccro@jhmi.edu

Principal Investigator:

Max Kates

FMH James M Stockman Cancer Institute

Recruiting

Frederick, Maryland, United States, 21702

Contacts

Site Public Contact

301-668-7043

Principal Investigator:

Heather Chalfin

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Site Public Contact

617-724-5200

Principal Investigator:

Filipe De Carvalho

Lahey Clinic

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Site Public Contact

781-744-3421lhmc-cancer-clinical-trials@lahey.org

Principal Investigator:

Matthew B. Clements

Lahey Clinic Peabody

Recruiting

Peabody, Massachusetts, United States, 01960

Contacts

Site Public Contact

781-744-3421lhmc-cancer-clinical-trials@lahey.org

Principal Investigator:

Matthew B. Clements

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Mark D. Tyson

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Great Falls Clinic

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Hi-Line Sletten Cancer Center

Recruiting

Havre, Montana, United States, 59501

Contacts

Site Public Contact

773-702-9171protocols@AllianceNCTN.org

Principal Investigator:

John M. Schallenkamp

Benefis Helena Specialty Center

Recruiting

Helena, Montana, United States, 59601

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Eugene J. Pietzak

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

551-996-2897

Principal Investigator:

Nitin Yerram

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Eugene J. Pietzak

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Eugene J. Pietzak

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Site Public Contact

800-767-9355askroswell@roswellpark.org

Principal Investigator:

Qiang J. Li

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Eugene J. Pietzak

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Eugene J. Pietzak

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Eugene J. Pietzak

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Eugene J. Pietzak

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Debasish Sundi

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Kelly L. Stratton

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Tullika Garg

Geisinger Cancer Center Dickson City

Recruiting

Dickson City, Pennsylvania, United States, 18519

Contacts

Site Public Contact

877-204-6081hemoncctrials@geisinger.edu

Principal Investigator:

Tullika Garg

Geisinger Medical Oncology-Lewisburg

Recruiting

Lewisburg, Pennsylvania, United States, 17837

Contacts

Site Public Contact

570-374-8555HemonCCTrials@geisinger.edu

Principal Investigator:

Tullika Garg

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Site Public Contact

215-728-4790

Principal Investigator:

Andres F. Correa

Fox Chase Cancer Center-Rockledge

Recruiting

Rockledge, Pennsylvania, United States, 19046

Contacts

Site Public Contact

888-823-5923ctsucontact@westat.com

Principal Investigator:

Andres F. Correa

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Tullika Garg

Ralph H Johnson VA Medical Center

Recruiting

Charleston, South Carolina, United States, 29401

Contacts

Site Public Contact

843-789-7020ashley.salvo@va.gov

Principal Investigator:

Stephen J. Savage

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Site Public Contact

843-792-9321hcc-clinical-trials@musc.edu

Principal Investigator:

Robert L. Grubb

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Alexander P. Kenigsberg

Memorial Hospital of Laramie County

Recruiting

Cheyenne, Wyoming, United States, 82001

Contacts

Site Public Contact

773-702-9171protocols@AllianceNCTN.org

Principal Investigator:

John M. Schallenkamp

Billings Clinic-Cody

Recruiting

Cody, Wyoming, United States, 82414

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-08-05.