S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
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ClinicalTrials.gov Identifier: NCT03091660 |
Recruitment Status :
Active, not recruiting
First Posted : March 27, 2017
Last Update Posted : May 3, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | March 21, 2017 | ||||
First Posted Date ICMJE | March 27, 2017 | ||||
Last Update Posted Date | May 3, 2024 | ||||
Actual Study Start Date ICMJE | February 24, 2017 | ||||
Estimated Primary Completion Date | December 15, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Disease free rates [ Time Frame: At 6 months ] Rates of patients who are disease free at six months versus not
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | PRIMARY OBJECTIVES: I. 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). II. 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: I. To compare time to recurrence (TTR) with any-grade (AG) bladder cancer between patients receiving Tokyo-172 versus TICE BCG strain. II. To compare TTR with AG bladder cancer between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG. III. To compare progression-free survival (PFS) between patients receiving Tokyo-172 versus TICE BCG strain. IV. To compare PFS between patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG. V. 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. VI. 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: I. 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). II. To test the hypothesis that urinary cytokine levels following BCG immunotherapy will predict time to high grade recurrence (TTHGR). III. 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Svatek RS, Tangen C, Delacroix S, Lowrance W, Lerner SP. Background and Update for 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. Eur Urol Focus. 2018 Jul;4(4):522-524. doi: 10.1016/j.euf.2018.08.015. Epub 2018 Sep 6. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
1000 | ||||
Original Estimated Enrollment ICMJE |
969 | ||||
Estimated Study Completion Date ICMJE | February 2025 | ||||
Estimated Primary Completion Date | December 15, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03091660 | ||||
Other Study ID Numbers ICMJE | S1602 NCI-2016-00451 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) S1602 ( Other Identifier: SWOG ) S1602 ( Other Identifier: CTEP ) U10CA180888 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | SWOG Cancer Research Network | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | SWOG Cancer Research Network | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | SWOG Cancer Research Network | ||||
Verification Date | May 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |