Could a vaccine before standard therapy keep bladder cancer away?

NCT ID NCT03091660

Disease control Sponsor: SWOG Cancer Research Network Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase III trial is testing whether a different strain of BCG (Tokyo-172) works better than the standard TICE strain for high-grade bladder cancer that hasn't spread into muscle. It also looks at whether giving a BCG vaccine under the skin before the usual bladder treatment helps prime the immune system. About 1000 patients are enrolled, and the main goal is to see which approach delays or prevents the cancer from returning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: BCG (Bacillus Calmette-Guerin) solution and vaccine
What this could lead to: If successful, this could show that a specific BCG strain or a priming vaccine before standard treatment works better to prevent bladder cancer from coming back.
What could go wrong: This is a large phase III trial, but results are not yet available. Different BCG strains may not differ in effectiveness, and the added vaccine could cause more side effects without clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,000 people

The number who actually took part.

Started

Feb 2017

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days of registration * Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration * Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of metastatic disease (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =\< T1 disease within 90 days prior to registration * Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification * Patients must not have pure squamous cell carcinoma or adenocarcinoma * Patients' disease must not have micropapillary components * Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms * Patients must not have nodal involvement or metastatic disease * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible * Patients must have a Zubrod performance status of 0-2 * Patients must not have received prior intravesical BCG * Patients must not have known history of tuberculosis * Patients must be PPD negative within 90 days prior to registration; PPD negativity is defined as \< 10 mm diameter induration (palpable, raised hardened area) in the volar forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1 ml) * Patients must be \>= 18 years of age * Patients must not be taking oral glucocorticoids at the time of registration * Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study * Prestudy history and physical must be obtained within 90days prior to registration * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * Patients must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ non-invasive bladder urothelial carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage 0 bladder urothelial carcinoma Stage 0IS bladder urothelial carcinoma Stage I bladder urothelial carcinoma

Contacts and locations

Locations

Arnot Ogden Medical Center/Falck Cancer Center

Elmira, New York, 14905, United States
Atlanta VA Medical Center

Decatur, Georgia, 30033, United States
Audie L Murphy VA Hospital

San Antonio, Texas, 78229, United States
Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States
Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States
Bay Area Hospital

Coos Bay, Oregon, 97420, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030, United States
Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle on Vermilion

Danville, Illinois, 61832, United States
Cedars Sinai Medical Center

Los Angeles, California, 90048, United States
Centralia Oncology Clinic

Centralia, Illinois, 62801, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169, United States
Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, 89144, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
East Jefferson General Hospital

Metairie, Louisiana, 70006, United States
Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States
Farmington Health Center

Farmington, Utah, 84025, United States
Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States
George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States
Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
Hawaii Cancer Care - Savio

‘Aiea, Hawaii, 96701, United States
Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States
Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, 48183, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, 48038, United States
Henry Ford Medical Center-Columbus

Novi, Michigan, 48377, United States
Henry Ford Medical Center-Fairlane

Dearborn, Michigan, 48126, United States
Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States
Hope Cancer Care of Nevada

Las Vegas, Nevada, 89103, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Indu and Raj Soin Medical Center

Beavercreek, Ohio, 45431, United States
Island Urology

Honolulu, Hawaii, 96813, United States
Island Urology-Hilo

Hilo, Hawaii, 96720, United States
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Kaiser Permanente-Oakland

Oakland, California, 94611, United States
Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States
Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
LSU Health Sciences Center at Shreveport

Shreveport, Louisiana, 71103, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006, United States
Las Vegas Prostate Cancer Center

Las Vegas, Nevada, 89113, United States
Las Vegas Urology - Cathedral Rock

Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Green Valley

Henderson, Nevada, 89074, United States
Las Vegas Urology - Pebble

Henderson, Nevada, 89074, United States
Las Vegas Urology - Pecos

Las Vegas, Nevada, 89074, United States
Las Vegas Urology - Smoke Ranch

Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Sunset

Las Vegas, Nevada, 89113, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States
Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States
Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
M D Anderson Cancer Center

Houston, Texas, 77030, United States
Madigan Army Medical Center

Tacoma, Washington, 98431, United States
Marshfield Clinic - Ladysmith Center

Ladysmith, Wisconsin, 54848, United States
Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, 54494, United States
Marshfield Clinic Stevens Point Center

Stevens Point, Wisconsin, 54482, United States
Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, 54729, United States
Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States
Marshfield Clinic-Wausau Center

Wausau, Wisconsin, 54401, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States
Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Medical Center

Springfield, Illinois, 62781, United States
Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Commack

Commack, New York, 11725, United States
Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States
Memorial Sloan Kettering Westchester

East White Plains, New York, 10604, United States
Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Moffitt Cancer Center

Tampa, Florida, 33612, United States
Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States
Northwestern University

Chicago, Illinois, 60611, United States
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at MountainView

Las Vegas, Nevada, 89128, United States
OptumCare Cancer Care at Oakey

Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States
Portland VA Medical Center

Portland, Oregon, 97239, United States
Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Greer

Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Laurens

Clinton, South Carolina, 29325, United States
Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, 29672, United States
Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States
Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States
Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States
Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States
Queen's Cancer Center - Pearlridge

‘Aiea, Hawaii, 96701, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106, United States
Ralph H Johnson VA Medical Center

Charleston, South Carolina, 29401, United States
Renown Regional Medical Center

Reno, Nevada, 89502, United States
Rogue Valley Medical Center

Medford, Oregon, 97504, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605, United States
Saint Alphonsus Medical Center-Nampa

Nampa, Idaho, 83686, United States
Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, 97914, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States
Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83686, United States
Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States
Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States
South Jordan Health Center

South Jordan, Utah, 84009, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Sparrow Hospital

Lansing, Michigan, 48912, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States
The Carle Foundation Hospital

Urbana, Illinois, 61801, United States
Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States
UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States
University Hospital

San Antonio, Texas, 78229, United States
University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States
University of Colorado Hospital

Aurora, Colorado, 80045, United States
University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States
University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States
University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States
University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
Urology Specialists of Nevada - Central

Las Vegas, Nevada, 89106, United States
Urology Specialists of Nevada - Green Valley

Henderson, Nevada, 89074, United States
Urology Specialists of Nevada - Northwest

Las Vegas, Nevada, 89128, United States
Urology Specialists of Nevada - Southwest

Las Vegas, Nevada, 89148, United States
West Virginia University Healthcare

Morgantown, West Virginia, 26506, United States
Yale University

New Haven, Connecticut, 06520, United States