Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy
NCT07000084
This study is recruiting at 60 US sites in 23 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Recurrent Non-Muscle Invasive Bladder Carcinoma
- Stage 0a Bladder Cancer AJCC v8
- Stage I Bladder Cancer AJCC v8
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Alliance for Clinical Trials in Oncology
- Last updated on ClinicalTrials.gov
- October 2, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- University of Alabama at Birmingham Cancer Center · Birmingham, AL
Alaska · 1
- Fairbanks Memorial Hospital · Fairbanks, AK
Arizona · 2
- Banner MD Anderson Cancer Center · Gilbert, AZ
- Mayo Clinic Hospital in Arizona · Phoenix, AZ
California · 2
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, CA
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, CA
District of Columbia · 1
- Sibley Memorial Hospital · Washington D.C., DC
Florida · 2
- UF Health Cancer Institute - Gainesville · Gainesville, FL
- Mayo Clinic in Florida · Jacksonville, FL
Idaho · 3
- Kootenai Health - Coeur d'Alene · Coeur d'Alene, ID
- Kootenai Clinic Cancer Services - Post Falls · Post Falls, ID
- Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, ID
Illinois · 4
- Northwestern University · Chicago, IL
- University of Illinois · Chicago, IL
- Loyola University Medical Center · Maywood, IL
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb · Melrose Park, IL
Indiana · 4
- IU Health West Hospital · Avon, IN
- IU Health North Hospital · Carmel, IN
- Indiana University/Melvin and Bren Simon Cancer Center · Indianapolis, IN
- IU Health Methodist Hospital · Indianapolis, IN
Louisiana · 1
- Mary Bird Perkins Cancer Center - Metairie · Metairie, LA
Maryland · 2
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, MD
- FMH James M Stockman Cancer Institute · Frederick, MD
Massachusetts · 3
- Brigham and Women's Hospital · Boston, MA
- Lahey Clinic · Burlington, MA
- Lahey Clinic Peabody · Peabody, MA
Minnesota · 1
- Mayo Clinic in Rochester · Rochester, MN
Montana · 9
- Community Hospital of Anaconda · Anaconda, MT
- Billings Clinic Cancer Center · Billings, MT
- Bozeman Health Deaconess Hospital · Bozeman, MT
- Benefis Sletten Cancer Institute · Great Falls, MT
- Great Falls Clinic · Great Falls, MT
- Hi-Line Sletten Cancer Center · Havre, MT
- Benefis Helena Specialty Center · Helena, MT
- Logan Health Medical Center · Kalispell, MT
- Community Medical Center · Missoula, MT
Nevada · 1
- Renown Regional Medical Center · Reno, NV
New Jersey · 4
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, NJ
- Hackensack University Medical Center · Hackensack, NJ
- Memorial Sloan Kettering Monmouth · Middletown, NJ
- Memorial Sloan Kettering Bergen · Montvale, NJ
New York · 6
- Roswell Park Cancer Institute · Buffalo, NY
- Memorial Sloan Kettering Commack · Commack, NY
- Memorial Sloan Kettering Westchester · Harrison, NY
- Memorial Sloan Kettering Cancer Center · New York, NY
- Veterans Affairs New York Harbor Healthcare System-Manhattan Campus · New York, NY
- Memorial Sloan Kettering Nassau · Uniondale, NY
Ohio · 1
- Ohio State University Comprehensive Cancer Center · Columbus, OH
Oklahoma · 1
- University of Oklahoma Health Sciences Center · Oklahoma City, OK
Pennsylvania · 6
- Geisinger Medical Center · Danville, PA
- Geisinger Cancer Center Dickson City · Dickson City, PA
- Geisinger Medical Oncology-Lewisburg · Lewisburg, PA
- Fox Chase Cancer Center · Philadelphia, PA
- Fox Chase Cancer Center-Rockledge · Rockledge, PA
- Geisinger Wyoming Valley/Henry Cancer Center · Wilkes-Barre, PA
South Carolina · 2
- Medical University of South Carolina · Charleston, SC
- Ralph H Johnson VA Medical Center · Charleston, SC
Virginia · 1
- VCU Massey Comprehensive Cancer Center · Richmond, VA
Wyoming · 2
- Memorial Hospital of Laramie County · Cheyenne, WY
- Billings Clinic-Cody · Cody, WY
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.