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Clinical Trial 19695

Cancer Type: Genitourinary
Interventions:BCG LIVE; Tokyo-172

Study Type: Treatment
Phase of Study: Phase III
Investigators:

  • Scott Gilbert

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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‐Naïve High‐Grade Non‐Muscle Invasive Bladder Cancer.

Summary

Objective

Primary Objectives: a. To compare whether time to high-grade recurrence (TTHGR) for patients with BCG-naïve, non-muscle invasive bladder cancer (NMIBC) receiving Tokyo-172 BCG (Arm 2) is non-inferior to patients receiving BCG LIVE (TICE® BCG) (Arm 1). b. To test whether TTHGR for patients with BCG-naïve, NMIBC receiving intradermal Tokyo-172 BCG vaccination followed by intravesical Tokyo-172 BCG instillation (Arm 3) is superior to patients receiving intravesical Tokyo-172 BCG instillation without prior intradermal BCG vaccination (Arm 2). 1.2 Secondary Objectives a. To compare time to recurrence (TTR) with any-grade (AG) bladder cancer between: 1. Patients receiving Tokyo-172 versus BCG LIVE (TICE® BCG) strain, 2. Patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG. b. To compare progression-free survival (PFS) between: 1. Patients receiving Tokyo-172 versus BCG LIVE (TICE® BCG) strain, 2. Patients receiving intradermal + intravesical versus intravesical only Tokyo-172 BCG. c. To estimate the complete response (CR) rate for CIS patients at 6 months in patients receiving intravesical Tokyo-172 BCG (Arms 2 & 3 will be evaluated separately). d. To evaluate the duration of CR by treatment arm for patients with CIS who have a CR at 6 months. e. To test whether TTHGR for patients with BCG-naïve, NMIBC receiving intradermal Tokyo-172 BCG vaccination followed by intravesical Tokyo-172 BCG instillation is superior to patients receiving intravesical TICE BCG strain. 1.3 Primary Translational Research Objectives a. 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). b. To test the hypothesis that urinary cytokine levels measured prior to weeks 1, 3 and 6 BCG instillation will predict time to high-grade recurrence (TTHGR). c. To test the hypothesis that tumor neoantigen burden and T-lymphocyte infiltration are associated with BCG response. d. To assess whether changes in pre-BCG extracellular vesicle profiles in urine and blood from week 1 to week 3 vary by treatment arm and whether these changes are prognostic for TTHGR. 1.4 Patient Reported Outcomes Objectives a. To compare the change (baseline to 6 month) in patient-reported bladder cancer-specific quality of life between TICE and Tokyo BCG strains. b. To compare the change (baseline to 6 month) in patient-reported quality of life between priming and no priming. c. To test the hypothesis that changes in urinary symptoms during BCG treatment predict time to high-grade recurrence (TTHGR). d. To evaluate whether smoking status is associated with time TTHGR, and whether the efficacy of BCG strain (Tice vs. Tokyo) and BCG priming is modified by measures of smoking exposure. e. To estimate adverse event profiles for each of the three treatment arms by smoking status.

Inclusion Criteria

  • Participants 18 years of age or older.
  • Participants must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days of registration
  • Participants 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
  • Participants 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; participants with T1 disease must have re-resection confirming =>Participants must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification
  • 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 participant is currently in complete remission, or any other cancer from which the participant has been disease free for five years; participants with localized prostate cancer who are being followed by an active surveillance program are also eligible
  • Participants must have a Zubrod performance status of 0-2 Participants must be PPD negative within 90 days prior to registration; PPD negativity is defined as > Prestudy history and physical must be obtained within 90days prior to registration
  • Participants 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 participant 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
  • Participants must be offered the opportunity to participate in specimen banking for future studies to include translational medicine studies

  • Exclusion Criteria

  • Participants must not have pure squamous cell carcinoma or adenocarcinoma
  • Participants' disease must not have micropapillary components
  • Participants 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
  • Participants must not have nodal involvement or metastatic disease
  • Participants must not be taking oral glucocorticoids at the time of registration
  • Participants must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study
  • Participants must not have received prior intravesical BCG
  • Participants must not have known history of tuberculosis