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

PHASE3RecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

July 17, 2025

Primary Completion Date

June 5, 2028

Study Completion Date

December 5, 2028

Conditions
Recurrent Non-Muscle Invasive Bladder CarcinomaStage 0a Bladder Cancer AJCC v8Stage I Bladder Cancer AJCC v8
Interventions
BIOLOGICAL

BCG Solution

Given intravesically

PROCEDURE

Biopsy of Bladder

Undergo bladder biopsy

PROCEDURE

Cystoscopy

Undergo cystoscopy

PROCEDURE

Computed Tomography

Undergo CT Scan

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Biospecimen Collection

Undergo blood and urine sample collection

PROCEDURE

Transurethral Resection of Bladder Tumor

Undergo TURBT

DRUG

Gemcitabine

Given intravesically

Trial Locations (42)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester, Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau, Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack, Commack

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

17822

RECRUITING

Geisinger Medical Center, Danville

17837

RECRUITING

Geisinger Medical Oncology-Lewisburg, Lewisburg

18519

RECRUITING

Geisinger Cancer Center Dickson City, Dickson City

18711

RECRUITING

Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre

19046

RECRUITING

Fox Chase Cancer Center-Rockledge, Rockledge

19111

RECRUITING

Fox Chase Cancer Center, Philadelphia

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

21702

RECRUITING

FMH James M Stockman Cancer Institute, Frederick

29401

RECRUITING

Ralph H Johnson VA Medical Center, Charleston

32610

RECRUITING

University of Florida Health Science Center - Gainesville, Gainesville

35233

RECRUITING

University of Alabama at Birmingham Cancer Center, Birmingham

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

59101

RECRUITING

Billings Clinic Cancer Center, Billings

59405

RECRUITING

Benefis Sletten Cancer Institute, Great Falls

RECRUITING

Great Falls Clinic, Great Falls

59501

RECRUITING

Hi-Line Sletten Cancer Center, Havre

59711

RECRUITING

Community Hospital of Anaconda, Anaconda

59715

RECRUITING

Bozeman Health Deaconess Hospital, Bozeman

59804

RECRUITING

Community Medical Center, Missoula

59901

RECRUITING

Logan Health Medical Center, Kalispell

60153

RECRUITING

Loyola University Medical Center, Maywood

60160

RECRUITING

Marjorie Weinberg Cancer Center at Loyola-Gottlieb, Melrose Park

60611

RECRUITING

Northwestern University, Chicago

60612

RECRUITING

University of Illinois, Chicago

70002

RECRUITING

Mary Bird Perkins Cancer Center - Metairie, Metairie

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

82414

RECRUITING

Billings Clinic-Cody, Cody

83814

RECRUITING

Kootenai Health - Coeur d'Alene, Coeur d'Alene

83854

RECRUITING

Kootenai Clinic Cancer Services - Post Falls, Post Falls

83864

RECRUITING

Kootenai Clinic Cancer Services - Sandpoint, Sandpoint

85054

RECRUITING

Mayo Clinic Hospital in Arizona, Phoenix

85234

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

32224-9980

RECRUITING

Mayo Clinic in Florida, Jacksonville

02115

RECRUITING

Brigham and Women's Hospital, Boston

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth, Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen, Montvale

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Alliance for Clinical Trials in Oncology

OTHER