Clinical trialNCT07000084RecruitingPhase 3Interventional

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

SponsorAlliance for Clinical Trials in OncologyEnrollment330Recurrent Non-Muscle Invasive Bladder CarcinomaStage 0a Bladder Cancer AJCC v8Stage I Bladder Cancer AJCC v8

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Eugene Pietzak, MD
Alliance for Clinical Trials in Oncology
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

58 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Charles C. Peyton
Recruiting
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
John M. Schallenkamp
Recruiting
Banner Md Anderson Cancer Center
Gilbert, Arizona, United States
Chinedu Mmeje
Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
Mark D. Tyson
Recruiting
Uci Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Michael Daneshvar
Recruiting
Uc Irvine Health/chao Family Comprehensive Cancer Center
Orange, California, United States
Michael Daneshvar
Recruiting
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Max Kates
Recruiting
Uf Health Cancer Institute - Gainesville
Gainesville, Florida, United States
Paul L. Crispen
Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mark D. Tyson
Recruiting
Kootenai Health - Coeur D'Alene
Coeur d'Alene, Idaho, United States
John M. Schallenkamp
Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
John M. Schallenkamp
Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
John M. Schallenkamp
Recruiting
Northwestern University
Chicago, Illinois, United States
Joshua J. Meeks
Recruiting
University of Illinois
Chicago, Illinois, United States
Daniel Moreira
Recruiting
Loyola University Medical Center
Maywood, Illinois, United States
Michael E. Woods
Recruiting
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, United States
Michael E. Woods
Recruiting
Iu Health West Hospital
Avon, Indiana, United States
Hristos Kaimakliotis
Recruiting
Iu Health North Hospital
Carmel, Indiana, United States
Hristos Kaimakliotis
Recruiting
Iu Health Methodist Hospital
Indianapolis, Indiana, United States
Hristos Kaimakliotis
Recruiting
Indiana University/melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Hristos Kaimakliotis
Recruiting
Mary Bird Perkins Cancer Center - Metairie
Metairie, Louisiana, United States
Scott E. Delacroix
Recruiting
Johns Hopkins University/sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Max Kates
Recruiting
Fmh James M Stockman Cancer Institute
Frederick, Maryland, United States
Heather Chalfin
Recruiting
Brigham and Women'S Hospital
Boston, Massachusetts, United States
Filipe De Carvalho
Recruiting
Lahey Clinic
Burlington, Massachusetts, United States
Matthew B. Clements
Recruiting
Lahey Clinic Peabody
Peabody, Massachusetts, United States
Matthew B. Clements
Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Mark D. Tyson
Recruiting
Community Hospital of Anaconda
Anaconda, Montana, United States
John M. Schallenkamp
Recruiting
Billings Clinic Cancer Center
Billings, Montana, United States
John M. Schallenkamp
Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
John M. Schallenkamp
Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
John M. Schallenkamp
Recruiting
Great Falls Clinic
Great Falls, Montana, United States
John M. Schallenkamp
Recruiting
Hi-Line Sletten Cancer Center
Havre, Montana, United States
John M. Schallenkamp
Recruiting
Benefis Helena Specialty Center
Helena, Montana, United States
John M. Schallenkamp
Recruiting
Logan Health Medical Center
Kalispell, Montana, United States
John M. Schallenkamp
Recruiting
Community Medical Center
Missoula, Montana, United States
John M. Schallenkamp
Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Eugene J. Pietzak
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Nitin Yerram
Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Eugene J. Pietzak
Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Eugene J. Pietzak
Recruiting

18 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BCGGemcitabine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Jul 2025
Primary completion: 5 Jun 2028
Completion: 5 Dec 2028
Last update posted: 5 Aug 2026
Registered enrollment: 330
Registry id: NCT07000084

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.