AzTrials
AzTrials

Non-muscle-invasive Bladder CancerPhase 3BRIDGENCT05538663

Intravesical BCG vs GEMDOCE in NMIBC

A Phase 3 study testing Gemcitabine, Docetaxel and Bacillus Calmette Guerin in people with Non-muscle-invasive Bladder Cancer, run by ECOG-ACRIN Cancer Research Group at 229 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-muscle-invasive Bladder Cancer
What is being tested?
Gemcitabine, Docetaxel and Bacillus Calmette Guerin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
870 participants
Where
229 sitesUnited States
Study dates
7 Feb 2023to Oct 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient must be > 18 years of age.
  • Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HgTa, HGT1, CIS, HgTa + CIS, or HGT1 + CIS stage) on transurethral resection of bladder tumor (TURBT) obtained within 90 days prior to randomization.
  • Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization. If the treating urologist did not perform the TURBT as outlined in Section 3.1.3, the treating urologist must perform a cystoscopy within 28 days prior to randomization to confirm the absence of visible papillary disease.
  • Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
  • Patients with high grade T1 disease must have undergone a restaging TURBT within 90 days prior to Step 1 randomization.
  • NOTE: Patients with high grade T1 disease who undergo a restaging TURBT that shows no residual cancer in the restaging TURBT specimen are eligible.
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  • Patient must not have pure squamous cell carcinoma or adenocarcinoma.
  • Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).
  • Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.
  • 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.
  • Patient must have ECOG Performance Status 0-2.
  • Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy.
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
  • Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 28 days prior to randomization):
  • Leukocytes ≥ 3,000/mcL Leukocytes: Date of Test: Absolute neutrophil count (ANC) ≥ 1,500/mcL ANC: Date of Test: Platelets ≥ 70,000/mcL Platelets: Date of Test: Total Bilirubin ≤ institutional upper limit of normal (ULN) Total Bilirubin: Institutional ULN: Date of Test: AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN AST: Institutional ULN: Date of Test: ALT: Institutional ULN:
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

Who cannot join

  • Patient must not have any prior or current history of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 90 days prior to randomization. The radiographic imaging includes a CT Scan OR MRI of the abdomen/pelvis with intravenous contrast.
  • NOTE: If a patient's renal function does not permit the administration of intravenous contrast, either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable.
  • NOTE: Patients with a history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e., either cytology, biopsy, or imaging) that demonstrates no evidence of residual disease are eligible.
  • 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: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) 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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  • Patient of child bearing potential? (Yes or No) Date of blood test or urine study:
  • Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. In addition,patients on Arm A must continue contraception measures for six months after the last dose of GEMDOCE for patients of child-bearing potential and continue for three month after the last dose of GEMDOC for male patients with partners of child-bearing potential. All patients must not breastfeed during their time on protocol treatment.
  • Patient must not have a history of severe hypersensitivity reactions to docetaxel or drugs formulated with polysorbate 80.

Trial locations and contacts

229 sites in 1 country.

229 sites in 1 country

United States229 sites

  • Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Saint Alphonsus Cancer Care Center-Baker City

    Baker City, Oregon, 97814

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Mercy Cancer Center - Carmichael

    Carmichael, California, 95608

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • MUSC Health Florence Medical Center

    Florence, South Carolina, 29505

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • University of Florida Health Science Center - Gainesville

    Gainesville, Florida, 32610

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Michael E DeBakey VA Medical Center

    Houston, Texas, 77030

  • MD Anderson West Houston

    Houston, Texas, 77079

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • Jersey City Medical Center

    Jersey City, New Jersey, 07302

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Monmouth Medical Center Southern Campus

    Lakewood, New Jersey, 08701

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan, 48910

  • MD Anderson League City

    League City, Texas, 77573

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Saint Joseph Hospital

    Lexington, Kentucky, 40504

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Saint Joseph London

    London, Kentucky, 40741

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Marjorie Weinberg Cancer Center at Loyola-Gottlieb

    Melrose Park, Illinois, 60160

  • Mercy Cancer Center

    Merced, California, 95340

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Community Medical Center

    Missoula, Montana, 59804

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Saint Joseph Mount Sterling

    Mount Sterling, Kentucky, 40353

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10029

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska, 68118

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

  • Mercy Health - Paducah Cancer Center

    Paducah, Kentucky, 42003

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • Jefferson Healthcare

    Port Townsend, Washington, 98368

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Reid Health

    Richmond, Indiana, 47374

  • Fox Chase Cancer Center-Rockledge

    Rockledge, Pennsylvania, 19046

  • Mercy Cancer Center - Rocklin

    Rocklin, California, 95765

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Mercy Cancer Center - Sacramento

    Sacramento, California, 95816

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

  • Pacific Central Coast Health Center-San Luis Obispo

    San Luis Obispo, California, 93401

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

  • Mission Hope Medical Oncology - Santa Maria

    Santa Maria, California, 93444

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • FHCC South Lake Union

    Seattle, Washington, 98109

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • Ochsner LSU Health - Cancer Treatment Center

    Shreveport, Louisiana, 71106

  • Saint Michael Cancer Center

    Silverdale, Washington, 98383

  • North Shore Medical Center

    Skokie, Illinois, 60076

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • Maine Medical Partners Urology

    South Portland, Maine, 04106

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • MD Anderson in Sugar Land

    Sugar Land, Texas, 77478

  • Moffitt Cancer Center-International Plaza

    Tampa, Florida, 33607

  • Moffitt Cancer Center - McKinley Campus

    Tampa, Florida, 33612

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Dayton Physicians LLC - Troy

    Troy, Ohio, 45373

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • BASS Medical Group - Lennon

    Walnut Creek, California, 94598

  • Saint Joseph Warren Hospital

    Warren, Ohio, 44484

  • Mercy Hospital Washington

    Washington, Missouri, 63090

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037

  • Moffitt Cancer Center at Wesley Chapel

    Wesley Chapel, Florida, 33544

  • Lexington Medical Center

    West Columbia, South Carolina, 29169

  • Woodland Memorial Hospital

    Woodland, California, 95695

  • UMass Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

  • Saint Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44501

Other trials in United States

About this study

Official title: A Randomized Phase III Trial of Intravesical BCG veRsus Intravesical Docetaxel and GEmcitabine Treatment in BCG Naïve High Grade Non-Muscle Invasive Bladder Cancer (BRIDGE)

The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

Read the detailed description

The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE

Being tested
Gemcitabine, Docetaxel, Bacillus Calmette Guerin
Medical subject headings
Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called GEMZAR

    Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years

  • DocetaxelDrug

    Also called Taxotere

    Intravesical once a week for 6 consecutive weeks followed by monthly instillations during maintenance for 2 years

  • Bacillus Calmette GuerinDrug

    Also called BCG

    intravesical once a week for 6 consecutive weeks during induction followed by weekly instillations for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 months

Study groups in NCT05538663
Study groupRoleWhat they receive
Arm AExperimentalGemcitabine + Docetaxel
Receives: Drug: Gemcitabine; Drug: Docetaxel
Arm BExperimentalBCG
Receives: Drug: Bacillus Calmette Guerin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-Free Survival

    To determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical BCG vs GEMDOCE.

    Measured: 2 years

Secondary outcomes (4)

  1. Quality of Life FACT-G

    To compare changes in cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE.

    Measured: 3 years

  2. Cystectomy free survival

    To determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

    Measured: 3 years

  3. Progression Free Survival

    To determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE

    Measured: 3 years

  4. Quality of Life EORTC NMIBC-24

    To compare changes in bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start7 Feb 2023
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
870 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05538663
Sponsor's protocol ID
EA8212
Other IDs
U10CA180820, NCI-2022-04864
Acronym
BRIDGE
Status last verified
Sep 2026
First submitted
25 Aug 2022
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cella L, Contieri R, Paciotti M, Fasulo V, Uleri A, Avolio PP, Mertens LS, Pradere B, Perdona S, Saita A, Lazzeri M, Casale P, Lughezzani G, Hurle R, Buffi NM. Artificial intelligence for predicting BCG response in non-muscle-invasive bladder cancer: a systematic review. BJU Int. 2026 Aug 17. doi: 10.1111/bju.70404. Online ahead of print.

    PubMed 42605566

  • Srivastava A, Trivedi S, Kumar U, Singh Y, Kumar L, Data S, Kumar A, Sankhwar SN. Quality of life and cost-effectiveness of intravesical gemcitabine/docetaxel vs BCG in BCG-naive non-muscle-invasive bladder cancer. BJU Int. 2026 Apr;137(4):639-649. doi: 10.1111/bju.70126. Epub 2025 Dec 23.

    PubMed 41436847

  • Koti M, Robert Siemens D. A Step Closer to Predicting Progression After Bacillus Calmette-Guerin Immunotherapy in High-risk Non-muscle-invasive Bladder Cancer. Eur Urol. 2023 Nov;84(5):447-448. doi: 10.1016/j.eururo.2023.06.017. Epub 2023 Jul 1.

    PubMed 37400353

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gemcitabine, Docetaxel and Bacillus Calmette Guerin in people with Non-muscle-invasive Bladder Cancer, run by ECOG-ACRIN Cancer Research Group at 229 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05538663, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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