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NCT05538663

Intravesical BCG vs GEMDOCE in NMIBC

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

870 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-07

Study Completion Date

2030-10-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Non-muscle-invasive Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Gemcitabine + Docetaxel

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

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

Docetaxel

Intervention Type DRUG

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

Arm B

BCG

Group Type EXPERIMENTAL

Bacillus Calmette Guerin

Intervention Type DRUG

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

Interventions

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Gemcitabine

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

Intervention Type DRUG

Docetaxel

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

Intervention Type DRUG

Bacillus Calmette Guerin

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

Intervention Type DRUG

Other Intervention Names

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GEMZAR Taxotere BCG

Eligibility Criteria

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Inclusion Criteria

* 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.

* 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.

Exclusion Criteria

* 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).

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status RECRUITING

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status RECRUITING

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status RECRUITING

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Site Status RECRUITING

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Site Status RECRUITING

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status RECRUITING

CARTI Cancer Center

Little Rock, Arkansas, United States

Site Status RECRUITING

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Site Status RECRUITING

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Site Status RECRUITING

Mercy San Juan Medical Center

Carmichael, California, United States

Site Status RECRUITING

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Site Status RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status RECRUITING

Mercy Cancer Center

Merced, California, United States

Site Status RECRUITING

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Site Status RECRUITING

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Site Status RECRUITING

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Site Status RECRUITING

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Site Status RECRUITING

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Site Status RECRUITING

BASS Medical Group - Lennon

Walnut Creek, California, United States

Site Status RECRUITING

Woodland Memorial Hospital

Woodland, California, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Site Status RECRUITING

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status RECRUITING

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Site Status RECRUITING

The Women's Imaging Center

Denver, Colorado, United States

Site Status RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status SUSPENDED

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status RECRUITING

Rose Medical Center

Denver, Colorado, United States

Site Status SUSPENDED

Mercy Medical Center

Durango, Colorado, United States

Site Status RECRUITING

Southwest Oncology PC

Durango, Colorado, United States

Site Status RECRUITING

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Site Status SUSPENDED

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Site Status RECRUITING

Swedish Medical Center

Englewood, Colorado, United States

Site Status SUSPENDED

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Site Status RECRUITING

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status RECRUITING

Longmont United Hospital

Longmont, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Site Status RECRUITING

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Site Status RECRUITING

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

George Washington University Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status RECRUITING

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Site Status SUSPENDED

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Site Status RECRUITING

Saint Anthony's Health

Alton, Illinois, United States

Site Status RECRUITING

Saint Mary's Hospital

Centralia, Illinois, United States

Site Status RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Site Status RECRUITING

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Site Status RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois, United States

Site Status RECRUITING

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status RECRUITING

North Shore Medical Center

Skokie, Illinois, United States

Site Status RECRUITING

Reid Health

Richmond, Indiana, United States

Site Status RECRUITING

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Boone

Boone, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

Site Status RECRUITING

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Site Status RECRUITING

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Site Status RECRUITING

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Site Status RECRUITING

Flaget Memorial Hospital

Bardstown, Kentucky, United States

Site Status RECRUITING

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, United States

Site Status RECRUITING

Saint Joseph Hospital

Lexington, Kentucky, United States

Site Status RECRUITING

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, United States

Site Status RECRUITING

Saint Joseph Hospital East

Lexington, Kentucky, United States

Site Status RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

Saint Joseph London

London, Kentucky, United States

Site Status RECRUITING

Saint Joseph Mount Sterling

Mount Sterling, Kentucky, United States

Site Status RECRUITING

Mercy Health - Paducah Cancer Center

Paducah, Kentucky, United States

Site Status RECRUITING

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status RECRUITING

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States

Site Status RECRUITING

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

Site Status RECRUITING

LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, United States

Site Status RECRUITING

Ochsner LSU Health - Cancer Treatment Center

Shreveport, Louisiana, United States

Site Status RECRUITING

Maine Medical Partners Urology

South Portland, Maine, United States

Site Status RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

Site Status RECRUITING

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, United States

Site Status RECRUITING

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Site Status RECRUITING

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Site Status RECRUITING

Cox Cancer Center Branson

Branson, Missouri, United States

Site Status RECRUITING

Freeman Health System

Joplin, Missouri, United States

Site Status RECRUITING

Mercy Hospital Joplin

Joplin, Missouri, United States

Site Status RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, United States

Site Status RECRUITING

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Site Status RECRUITING

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status RECRUITING

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status RECRUITING

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status RECRUITING

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital South

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital Washington

Washington, Missouri, United States

Site Status RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Great Falls Clinic

Great Falls, Montana, United States

Site Status RECRUITING

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status RECRUITING

Community Medical Center

Missoula, Montana, United States

Site Status RECRUITING

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Site Status RECRUITING