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

Sponsor
Southwest Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03091660
Collaborator
National Cancer Institute (NCI) (NIH)
1,000
Enrollment
174
Locations
3
Arms
95.8
Anticipated Duration (Months)
5.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: BCG Solution
  • Biological: BCG Tokyo-172 Strain Solution
  • Biological: BCG Tokyo-172 Strain Vaccine
  • Other: Laboratory Biomarker Analysis
 Phase 3

Detailed Description

PRIMARY OBJECTIVES:

  1. To compare whether time to high grade recurrence (TTHGR) for patients with BCG-naïve, non-muscle invasive bladder cancer (NMIBC) receiving Tokyo-172 BCG strain (Arm II) is non-inferior to patients receiving TICE BCG strain (Arm I).

  2. To test whether TTHGR for patients with BCG-naïve, NMIBC receiving intradermal Tokyo-172 BCG vaccination followed by intravesical Tokyo-172 BCG instillation (Arm III) is superior to patients receiving intravesical Tokyo-172BCG instillation without prior intradermal BCG vaccination (Arm II).

SECONDARY OBJECTIVES:

  1. To compare time to recurrence (TTR) with any-grade (AG) bladder cancer between patients receiving Tokyo-172 versus TICE BCG strain.

  2. To compare TTR with AG bladder cancer between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.

  3. To compare progression-free survival (PFS) between patients receiving Tokyo-172 versus TICE BCG strain.

  4. To compare PFS between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.

  5. To compare 6-month complete response in patients with carcinoma in situ (CIS) with or without Ta or T1 cancer present at baseline receiving Tokyo-172 versus TICE BCG strain.

  6. To compare 6-month complete response in patients with CIS with or without Ta or T1 cancer present at baseline receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG.

TERTIARY OBJECTIVES:

  1. To test the hypothesis that purified protein derivative (PPD) test conversion (positive PPD at 3 or 6 months) following BCG immunotherapy will predict time to high grade recurrence (TTHGR).

  2. To test the hypothesis that urinary cytokine levels following BCG immunotherapy will predict time to high grade recurrence (TTHGR).

  3. To test the hypothesis that tumor neoantigen burden and T lymphocyte infiltration are associated with BCG response.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I:

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.

ARM II:

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.

ARM III:

PRIME: Patients receive Tokyo-172 strain BCG vaccine once intradermally (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.

After completion of study treatment, patients are followed up for 5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 7, 2017
Anticipated Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (BCG solution)

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 Solution
Given intravesically
Other Names:
  • Bacillus Calmette-Guerin Solution
  • TICE BCG Solution

    • Other: Laboratory Biomarker Analysis
    Correlative studies
    Experimental: Arm II (Tokyo-172 strain BCG solution)

    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 Solution
    Given intravesically
    Other Names:
  • Bacillus Calmette-Guerin Tokyo-172 Strain Solution
  • Immunobladder

    • Other: Laboratory Biomarker Analysis
    Correlative studies
    Experimental: Arm III (Tokyo-172 strain BCG solution with priming)

    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 Solution
    Given intravesically
    Other Names:
  • Bacillus Calmette-Guerin Tokyo-172 Strain Solution
  • Immunobladder

    • Biological: BCG Tokyo-172 Strain Vaccine
    Given ID
    Other Names:
  • Bacillus Calmette-Guerin Tokyo-172 Strain Vaccine

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. TTHGR for Arm I compared to Arm II [Time from randomization to first high grade recurrence assessed up to 5 years]

      Time to High Grade Recurrence

    2. TTHGR for Arm II compared to Arm III [Time from randomization to first high grade recurrence assessed up to 5 years]

      Time to High Grade Recurrence

    Secondary Outcome Measures

    1. Disease free rates [At 6 months]

      Rates of patients who are disease free at six months versus not

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36688
    2 Banner MD Anderson Cancer Center Gilbert Arizona United States 85234
    3 Mayo Clinic Hospital in Arizona Phoenix Arizona United States 85054
    4 Mayo Clinic in Arizona Scottsdale Arizona United States 85259
    5 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    6 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    7 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    8 Cedars Sinai Medical Center Los Angeles California United States 90048
    9 Kaiser Permanente-Oakland Oakland California United States 94611
    10 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    11 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
    12 Kaiser Permanente-South Sacramento Sacramento California United States 95823
    13 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    14 Kaiser Permanente-Vallejo Vallejo California United States 94589
    15 Kaiser Permanente-Walnut Creek Walnut Creek California United States 94596
    16 University of Colorado Hospital Aurora Colorado United States 80045
    17 Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut United States 06510
    18 Yale University New Haven Connecticut United States 06520
    19 MedStar Washington Hospital Center Washington District of Columbia United States 20010
    20 George Washington University Medical Center Washington District of Columbia United States 20037
    21 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    22 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
    23 Moffitt Cancer Center - McKinley Campus Tampa Florida United States 33612
    24 Moffitt Cancer Center Tampa Florida United States 33612
    25 Atlanta VA Medical Center Decatur Georgia United States 30033
    26 Hawaii Cancer Care - Savio 'Aiea Hawaii United States 96701
    27 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    28 Queen's Cancer Center - Pearlridge 'Aiea Hawaii United States 96701
    29 Island Urology-Hilo Hilo Hawaii United States 96720
    30 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    31 Island Urology Honolulu Hawaii United States 96813
    32 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    33 Queen's Medical Center Honolulu Hawaii United States 96813
    34 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    35 University of Hawaii Cancer Center Honolulu Hawaii United States 96813
    36 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    37 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    38 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    39 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    40 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    41 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    42 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    43 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    44 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    45 Centralia Oncology Clinic Centralia Illinois United States 62801
    46 Northwestern University Chicago Illinois United States 60611
    47 University of Illinois Chicago Illinois United States 60612
    48 Carle on Vermilion Danville Illinois United States 61832
    49 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    50 Decatur Memorial Hospital Decatur Illinois United States 62526
    51 Carle Physician Group-Effingham Effingham Illinois United States 62401
    52 Crossroads Cancer Center Effingham Illinois United States 62401
    53 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    54 Loyola University Medical Center Maywood Illinois United States 60153
    55 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    56 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    57 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    58 Springfield Clinic Springfield Illinois United States 62702
    59 Memorial Medical Center Springfield Illinois United States 62781
    60 Carle Cancer Center Urbana Illinois United States 61801
    61 The Carle Foundation Hospital Urbana Illinois United States 61801
    62 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    63 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    64 East Jefferson General Hospital Metairie Louisiana United States 70006
    65 LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana United States 70006
    66 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
    67 University Medical Center New Orleans New Orleans Louisiana United States 70112
    68 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    69 LSU Health Sciences Center at Shreveport Shreveport Louisiana United States 71103
    70 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    71 Brigham and Women's Hospital Boston Massachusetts United States 02115
    72 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    73 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    74 Henry Ford Cancer Institute-Downriver Brownstown Michigan United States 48183
    75 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    76 Henry Ford Medical Center-Fairlane Dearborn Michigan United States 48126
    77 Henry Ford Hospital Detroit Michigan United States 48202
    78 Sparrow Hospital Lansing Michigan United States 48912
    79 Henry Ford Medical Center-Columbus Novi Michigan United States 48377
    80 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    81 Henry Ford West Bloomfield Hospital West Bloomfield Michigan United States 48322
    82 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    83 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    84 Mercy Hospital Springfield Springfield Missouri United States 65804
    85 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    86 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
    87 Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada United States 89052
    88 OptumCare Cancer Care at Seven Hills Henderson Nevada United States 89052
    89 Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada United States 89074
    90 Las Vegas Urology - Green Valley Henderson Nevada United States 89074
    91 Las Vegas Urology - Pebble Henderson Nevada United States 89074
    92 Urology Specialists of Nevada - Green Valley Henderson Nevada United States 89074
    93 Las Vegas Urology - Pecos Las Vegas Nevada United States 89074
    94 OptumCare Cancer Care at Oakey Las Vegas Nevada United States 89102
    95 Hope Cancer Care of Nevada Las Vegas Nevada United States 89103
    96 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    97 Urology Specialists of Nevada - Central Las Vegas Nevada United States 89106
    98 Las Vegas Prostate Cancer Center Las Vegas Nevada United States 89113
    99 Las Vegas Urology - Sunset Las Vegas Nevada United States 89113
    100 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    101 Las Vegas Urology - Cathedral Rock Las Vegas Nevada United States 89128
    102 Las Vegas Urology - Smoke Ranch Las Vegas Nevada United States 89128
    103 OptumCare Cancer Care at MountainView Las Vegas Nevada United States 89128
    104 Urology Specialists of Nevada - Northwest Las Vegas Nevada United States 89128
    105 Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada United States 89144
    106 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
    107 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    108 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    109 Urology Specialists of Nevada - Southwest Las Vegas Nevada United States 89148
    110 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    111 Renown Regional Medical Center Reno Nevada United States 89502
    112 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    113 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
    114 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    115 Roswell Park Cancer Institute Buffalo New York United States 14263
    116 Memorial Sloan Kettering Commack Commack New York United States 11725
    117 Arnot Ogden Medical Center/Falck Cancer Center Elmira New York United States 14905
    118 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    119 Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York United States 10016
    120 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    121 University of Rochester Rochester New York United States 14642
    122 State University of New York Upstate Medical University Syracuse New York United States 13210
    123 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    124 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    125 Indu and Raj Soin Medical Center Beavercreek Ohio United States 45431
    126 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    127 Kettering Medical Center Kettering Ohio United States 45429
    128 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    129 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    130 Bay Area Hospital Coos Bay Oregon United States 97420
    131 Rogue Valley Medical Center Medford Oregon United States 97504
    132 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    133 Oregon Health and Science University Portland Oregon United States 97239
    134 Portland VA Medical Center Portland Oregon United States 97239
    135 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    136 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
    137 Ralph H Johnson VA Medical Center Charleston South Carolina United States 29401
    138 Prisma Health Cancer Institute - Laurens Clinton South Carolina United States 29325
    139 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    140 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    141 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    142 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
    143 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    144 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    145 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    146 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    147 University of Texas Medical Branch Galveston Texas United States 77555-0565
    148 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    149 Houston Methodist Hospital Houston Texas United States 77030
    150 M D Anderson Cancer Center Houston Texas United States 77030
    151 UTMB Cancer Center at Victory Lakes League City Texas United States 77573
    152 Audie L Murphy VA Hospital San Antonio Texas United States 78229
    153 University Hospital San Antonio Texas United States 78229
    154 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    155 Farmington Health Center Farmington Utah United States 84025
    156 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    157 South Jordan Health Center South Jordan Utah United States 84009
    158 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    159 Seattle Cancer Care Alliance Seattle Washington United States 98109
    160 University of Washington Medical Center - Montlake Seattle Washington United States 98195
    161 Madigan Army Medical Center Tacoma Washington United States 98431
    162 West Virginia University Healthcare Morgantown West Virginia United States 26506
    163 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    164 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    165 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    166 Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin United States 54848
    167 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    168 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    169 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    170 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    171 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    172 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    173 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    174 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Robert Svatek, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT03091660
    Other Study ID Numbers:
    • S1602
    • NCI-2016-00451
    • S1602
    • S1602
    • U10CA180888
    First Posted:
    Mar 27, 2017
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Urinary Bladder Neoplasms
    Carcinoma, Transitional Cell
    Pharmaceutical Solutions
    Vaccines
    BCG Vaccine

    Study Results

    No Results Posted as of Mar 10, 2022