NCT03091660|Active Not RecruitingPhase 3DMCFDA Drug

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

S1602, A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming With Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-muscle Invasive Bladder Cancer

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

S1602NCI-2016-00451U10CA180888

Study Type

interventional

Target

1,000

Locations

1 country

Sites

174

Timeline

RegisteredMar 2017

StartedFeb 2017

CompletionJun 2026

Brief Summary

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,000

participants targeted

Target at P75+ for phase_3

Timeline

1mo left

Started Feb 2017

Longer than P75 for phase_3

Geographic Reach

1 country

174 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.3 years study duration

Study Progress99%

Feb 2017Jun 2026

Study Start

First participant enrolled

February 24, 2017

Completed

25 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed

8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Expected

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

8.9 years

First QC Date

March 21, 2017

Last Update Submit

March 20, 2026

Conditions

Stage 0 Bladder Urothelial Carcinoma Stage 0is Bladder Urothelial Carcinoma Stage I Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

TTHGR for Arm I compared to Arm II
Time to High Grade Recurrence
Time from randomization to first high grade recurrence assessed up to 5 years
TTHGR for Arm II compared to Arm III
Time to High Grade Recurrence
Time from randomization to first high grade recurrence assessed up to 5 years

Secondary Outcomes (1)

Disease free rates
At 6 months

Study Arms (3)

Arm I (BCG solution)

ACTIVE COMPARATOR

INDUCTION: Patients receive TICE BCG solution intravesically once a week for 6 weeks. MAINTENANCE: Patients receive TICE BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.

Biological: BCG SolutionOther: Laboratory Biomarker Analysis

Arm II (Tokyo-172 strain BCG solution)

EXPERIMENTAL

INDUCTION: Patients receive Tokyo-172 strain BCG solution intravesically once a week for 6 weeks. MAINTENANCE: Patients receive Tokyo-172 strain BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.

Biological: BCG Tokyo-172 Strain SolutionOther: Laboratory Biomarker Analysis

Arm III (Tokyo-172 strain BCG solution with priming)

EXPERIMENTAL

PRIME: Patients receive Tokyo-172 strain BCG vaccine once ID. INDUCTION: Within 21 days, patients receive Tokyo-172 strain BCG solution as in Arm II. MAINTENANCE: Patients receive Tokyo-172 strain BCG solution as in Arm II.

Biological: BCG Tokyo-172 Strain SolutionBiological: BCG Tokyo-172 Strain VaccineOther: Laboratory Biomarker Analysis

Interventions

BCG Tokyo-172 Strain VaccineBIOLOGICAL

Given ID

Also known as: Bacillus Calmette-Guerin Tokyo-172 Strain Vaccine

Arm III (Tokyo-172 strain BCG solution with priming)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (BCG solution)Arm II (Tokyo-172 strain BCG solution)Arm III (Tokyo-172 strain BCG solution with priming)

BCG SolutionBIOLOGICAL

Given intravesically

Also known as: Bacillus Calmette-Guerin Solution, TICE BCG Solution

Arm I (BCG solution)

BCG Tokyo-172 Strain SolutionBIOLOGICAL

Given intravesically

Also known as: Bacillus Calmette-Guerin Tokyo-172 Strain Solution, Immunobladder

Arm II (Tokyo-172 strain BCG solution)Arm III (Tokyo-172 strain BCG solution with priming)

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (174)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

UCSF Medical Center-Mission Bay

San Francisco, California, 94158, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

George Washington University Medical Center

Washington D.C., District of Columbia, 20037, United States

Location

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Island Urology-Hilo

Hilo, Hawaii, 96720, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza