ClinicalTrials.gov record
Intravesical BCG vs GEMDOCE in NMIBC
ClinicalTrials.gov ID: NCT05538663
Public ClinicalTrials.gov record NCT05538663. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05538663
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 870 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 7, 2023 (Actual)
- Primary completion
- Nov 1, 2029 (Estimated)
- Completion
- Oct 2030 (Estimated)
- Last update posted
- Sep 15, 2026
2023 – 2030
United States locations
- U.S. sites
- 229
- U.S. states
- 38
- U.S. cities
- 166
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | — |
| Fairbanks Memorial Hospital | Fairbanks | Alaska | 99701 | — |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| CTCA at Western Regional Medical Center | Goodyear | Arizona | 85338 | — |
| Cancer Center at Saint Joseph's | Phoenix | Arizona | 85004 | — |
| Mercy Hospital Fort Smith | Fort Smith | Arkansas | 72903 | — |
| CARTI Cancer Center | Little Rock | Arkansas | 72205 | — |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | 93420 | — |
| Mercy Cancer Center - Carmichael | Carmichael | California | 95608 | — |
| Mercy San Juan Medical Center | Carmichael | California | 95608 | — |
| Mercy Cancer Center - Elk Grove | Elk Grove | California | 95758 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | — |
| Mercy Cancer Center | Merced | California | 95340 | — |
| Mercy Cancer Center - Rocklin | Rocklin | California | 95765 | — |
| Mercy Cancer Center - Sacramento | Sacramento | California | 95816 | — |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | — |
| Pacific Central Coast Health Center-San Luis Obispo | San Luis Obispo | California | 93401 | — |
| Mission Hope Medical Oncology - Santa Maria | Santa Maria | California | 93444 | — |
| BASS Medical Group - Lennon | Walnut Creek | California | 94598 | — |
| Woodland Memorial Hospital | Woodland | California | 95695 | — |
| Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | 80012 | — |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Boulder Community Foothills Hospital | Boulder | Colorado | 80303 | — |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | — |
| Rocky Mountain Cancer Centers - Centennial | Centennial | Colorado | 80112 | — |
| 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 | — |
| 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 | — |
| Mercy Medical Center | Durango | Colorado | 81301 | — |
| Southwest Oncology PC | Durango | Colorado | 81301 | — |
| 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 | — |
| Rocky Mountain Cancer Centers-Lakewood | Lakewood | Colorado | 80228 | — |
| Saint Anthony Hospital | Lakewood | Colorado | 80228 | — |
| Rocky Mountain Cancer Centers-Littleton | Littleton | Colorado | 80120 | — |
| Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | 80124 | — |
| Longmont United Hospital | Longmont | Colorado | 80501 | — |
| Rocky Mountain Cancer Centers-Longmont | Longmont | Colorado | 80501 | — |
| Saint Mary Corwin Medical Center | Pueblo | Colorado | 81004 | — |
| Rocky Mountain Cancer Centers-Thornton | Thornton | Colorado | 80260 | — |
| 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 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| Moffitt Cancer Center-International Plaza | Tampa | Florida | 33607 | — |
| Moffitt Cancer Center - McKinley Campus | Tampa | Florida | 33612 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Moffitt Cancer Center at Wesley Chapel | Wesley Chapel | Florida | 33544 | — |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | — |
| Saint Alphonsus Cancer Care Center-Caldwell | Caldwell | Idaho | 83605 | — |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | — |
| Walter Knox Memorial Hospital | Emmett | Idaho | 83617 | — |
| Idaho Urologic Institute-Meridian | Meridian | Idaho | 83642 | — |
| Saint Alphonsus Cancer Care Center-Nampa | Nampa | Idaho | 83687 | — |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | — |
| Kootenai Clinic Cancer Services - Sandpoint | Sandpoint | Idaho | 83864 | — |
| Saint Anthony's Health | Alton | Illinois | 62002 | — |
| Saint Mary's Hospital | Centralia | Illinois | 62801 | — |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | — |
| NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | 60201 | — |
| NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois | 60026 | — |
| NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois | 60035 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Marjorie Weinberg Cancer Center at Loyola-Gottlieb | Melrose Park | Illinois | 60160 | — |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | — |
| North Shore Medical Center | Skokie | Illinois | 60076 | — |
| Reid Health | Richmond | Indiana | 47374 | — |
| Mary Greeley Medical Center | Ames | Iowa | 50010 | — |
| McFarland Clinic - Ames | Ames | Iowa | 50010 | — |
| McFarland Clinic - Boone | Boone | Iowa | 50036 | — |
| McFarland Clinic - Trinity Cancer Center | Fort Dodge | Iowa | 50501 | — |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| McFarland Clinic - Jefferson | Jefferson | Iowa | 50129 | — |
| McFarland Clinic - Marshalltown | Marshalltown | Iowa | 50158 | — |
| Central Care Cancer Center - Garden City | Garden City | Kansas | 67846 | — |
| Central Care Cancer Center - Great Bend | Great Bend | Kansas | 67530 | — |
| Flaget Memorial Hospital | Bardstown | Kentucky | 40004 | — |
| Commonwealth Cancer Center-Corbin | Corbin | Kentucky | 40701 | — |
| 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 | — |
| Saint Joseph London | London | Kentucky | 40741 | — |
| Saint Joseph Mount Sterling | Mount Sterling | Kentucky | 40353 | — |
| Mercy Health - Paducah Cancer Center | Paducah | Kentucky | 42003 | — |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | — |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic | Metairie | Louisiana | 70006 | — |
| Louisiana State University Health Science Center | New Orleans | Louisiana | 70112 | — |
| LSU Health Sciences Center at Shreveport | Shreveport | Louisiana | 71103 | — |
| Ochsner LSU Health - Cancer Treatment Center | Shreveport | Louisiana | 71106 | — |
| Maine Medical Partners Urology | South Portland | Maine | 04106 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | 01655 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | — |
| Karmanos Cancer Institute at McLaren Greater Lansing | Lansing | Michigan | 48910 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Saint Louis Cancer and Breast Institute-Ballwin | Ballwin | Missouri | 63011 | — |
| Central Care Cancer Center - Bolivar | Bolivar | Missouri | 65613 | — |
| Cox Cancer Center Branson | Branson | Missouri | 65616 | — |
| Freeman Health System | Joplin | Missouri | 64804 | — |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | — |
| Lake Regional Hospital | Osage Beach | Missouri | 65065 | — |
| Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | 65401 | — |
| Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri | 65401 | — |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | — |
| 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 | — |
| Mercy Hospital Washington | Washington | Missouri | 63090 | — |
| Community Hospital of Anaconda | Anaconda | Montana | 59711 | — |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | — |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | — |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | — |
| Great Falls Clinic | Great Falls | Montana | 59405 | — |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | — |
| Community Medical Center | Missoula | Montana | 59804 | — |
| Nebraska Medicine-Bellevue | Bellevue | Nebraska | 68123 | — |
| CHI Health Good Samaritan | Kearney | Nebraska | 68847 | — |
| 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 | — |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Jersey City Medical Center | Jersey City | New Jersey | 07302 | — |
| Monmouth Medical Center Southern Campus | Lakewood | New Jersey | 08701 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07101 | — |
| Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | 08876 | — |
| Community Medical Center | Toms River | New Jersey | 08755 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester | East White Plains | New York | 10604 | — |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | — |
| 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 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | — |
| Indu and Raj Soin Medical Center | Beavercreek | Ohio | 45431 | — |
| Saint Elizabeth Boardman Hospital | Boardman | Ohio | 44512 | — |
| Dayton Physicians LLC-Miami Valley South | Centerville | Ohio | 45459 | — |
| 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 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Dayton Physician LLC - Englewood | Dayton | Ohio | 45415 | — |
| Armes Family Cancer Center | Findlay | Ohio | 45840 | — |
| Blanchard Valley Hospital | Findlay | Ohio | 45840 | — |
| Orion Cancer Care | Findlay | Ohio | 45840 | — |
| Dayton Physicians LLC-Atrium | Franklin | Ohio | 45005 | — |
| Dayton Physicians LLC-Wayne | Greenville | Ohio | 45331 | — |
| Wayne Hospital | Greenville | Ohio | 45331 | — |
| Greater Dayton Cancer Center | Kettering | Ohio | 45409 | — |
| Kettering Medical Center | Kettering | Ohio | 45429 | — |
| Dayton Physicians LLC - Troy | Troy | Ohio | 45373 | — |
| Saint Joseph Warren Hospital | Warren | Ohio | 44484 | — |
| Saint Elizabeth Youngstown Hospital | Youngstown | Ohio | 44501 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | 73120 | — |
| Saint Alphonsus Cancer Care Center-Baker City | Baker City | Oregon | 97814 | — |
| Saint Alphonsus Cancer Care Center-Ontario | Ontario | Oregon | 97914 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Portland VA Medical Center | Portland | Oregon | 97239 | — |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | — |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Fox Chase Cancer Center-Rockledge | Rockledge | Pennsylvania | 19046 | — |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | — |
| Ralph H Johnson VA Medical Center | Charleston | South Carolina | 29401 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| MUSC Health Florence Medical Center | Florence | South Carolina | 29505 | — |
| Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | 29605 | — |
| Lexington Medical Center | West Columbia | South Carolina | 29169 | — |
| MD Anderson in The Woodlands | Conroe | Texas | 77384 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | — |
| 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 | — |
| MD Anderson League City | League City | Texas | 77573 | — |
| UTMB Cancer Center at Victory Lakes | League City | Texas | 77573 | — |
| MD Anderson in Sugar Land | Sugar Land | Texas | 77478 | — |
| Jefferson Healthcare | Port Townsend | Washington | 98368 | — |
| 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 | — |
| Saint Michael Cancer Center | Silverdale | Washington | 98383 | — |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Cheyenne Regional Medical Center-West | Cheyenne | Wyoming | 82001 | — |
| Billings Clinic-Cody | Cody | Wyoming | 82414 | — |
| Welch Cancer Center | Sheridan | Wyoming | 82801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05538663, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05538663 live on ClinicalTrials.gov.