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Brief Title: 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

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

INTRODUCTION

  • Org Study ID: S1602
  • Secondary ID: NCI-2016-00451, S1602, S1602, U10CA180888
  • NTC ID: NCT03091660
  • Sponsor: Southwest Oncology Group

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.


  • Overall Status
    Recruiting
  • Start Date
    February 7, 2017
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: TTHGR for Arm I compared to Arm II

Primary Outcome 1 - Timeframe: Time from randomization to first high grade recurrence assessed up to 5 years

Primary Outcome 2 - Measure: TTHGR for Arm II compared to Arm III

Primary Outcome 2 - Timeframe: Time from randomization to first high grade recurrence assessed up to 5 years

CONDITION

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

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Robert Svatek

Role: Principal Investigator

Affiliation: Southwest Oncology Group

Overall Contact

Name: Robert Svatek

Phone: (210)614-8808

Email: vgarcia@swog.org

LOCATION

Facility Status Contact
Facility: University of South Alabama Mitchell Cancer Institute
Mobile, Alabama 36688
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Reno, Nevada 89502
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New York, New York 10016
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Rochester, New York 14642
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Syracuse, New York 13210
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Facility: Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United States
Status: Recruiting Contact:
Site Public Contact
212-639-7592
Facility: UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu
Facility: Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
United States
Status: Recruiting Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org
Facility: Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Status: Recruiting Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu
Facility: Kettering Medical Center
Kettering, Ohio 45429
United States
Status: Recruiting Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org
Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu
Facility: Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
United States
Status: Recruiting Contact:
Site Public Contact
405-752-3402
Facility: Bay Area Hospital
Coos Bay, Oregon 97420
United States
Status: Recruiting Contact:
Site Public Contact
541-269-8392
cherie.cox@bayareahospital.org
Facility: Rogue Valley Medical Center
Medford, Oregon 97504
United States
Status: Recruiting Contact:
Site Public Contact
541-789-6176
Facility: Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
United States
Status: Recruiting Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Oregon Health and Science University
Portland, Oregon 97239
United States
Status: Recruiting Contact:
Site Public Contact
503-494-1080
trials@ohsu.edu
Facility: Portland VA Medical Center
Portland, Oregon 97239
United States
Status: Recruiting Contact:
Site Public Contact
800-949-1004
Facility: Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact:
Site Public Contact
215-955-6084
Facility: Ralph H Johnson VA Medical Center
Charleston, South Carolina 29401
United States
Status: Recruiting Contact:
Site Public Contact
843-789-7020
ashley.salvo@va.gov
Facility: Prisma Health Cancer Institute - Laurens
Clinton, South Carolina 29325
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: Prisma Health Cancer Institute - Spartanburg
Spartanburg, South Carolina 29307
United States
Status: Recruiting Contact:
Site Public Contact
864-522-2066
kim.williams3@prismahealth.org
Facility: UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
Status: Recruiting Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu
Facility: University of Texas Medical Branch
Galveston, Texas 77555-0565
United States
Status: Recruiting Contact:
Site Public Contact
409-772-1950
clinical.research@utmb.edu
Facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact:
Site Public Contact
713-798-1354
burton@bcm.edu
Facility: Houston Methodist Hospital
Houston, Texas 77030
United States
Status: Recruiting Contact:
Site Public Contact
713-790-2700
Facility: M D Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact:
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org
Facility: UTMB Cancer Center at Victory Lakes
League City, Texas 77573
United States
Status: Recruiting Contact:
Site Public Contact
800-917-8906
Facility: Audie L Murphy VA Hospital
San Antonio, Texas 78229
United States
Status: Recruiting Contact:
Site Public Contact
877-469-5300
Facility: University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact:
Site Public Contact
210-450-3800
phoresearchoffice@uthscsa.edu
Facility: Farmington Health Center
Farmington, Utah 84025
United States
Status: Recruiting Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu
Facility: Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu
Facility: South Jordan Health Center
South Jordan, Utah 84009
United States
Status: Recruiting Contact:
Site Public Contact
888-424-2100
cancerinfo@hci.utah.edu
Facility: Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States
Status: Recruiting Contact:
Site Public Contact
800-804-8824
Facility: Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact:
Site Public Contact
800-804-8824
Facility: University of Washington Medical Center
Seattle, Washington 98195
United States
Status: Recruiting Contact:
Site Public Contact
800-804-8824
Facility: Madigan Army Medical Center
Tacoma, Washington 98431
United States
Status: Recruiting Contact:
Site Public Contact
253-968-0129
mamcdci@amedd.army.mil
Facility: West Virginia University Healthcare
Morgantown, West Virginia 26506
United States
Status: Recruiting Contact:
Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu
Facility: Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin 54729
United States
Status: Recruiting Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Facility: Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
United States
Status: Recruiting Contact:
Site Public Contact
608-775-2385
cancerctr@gundersenhealth.org
Facility: Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin 54848
United States
Status: Recruiting Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Facility: Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact:
Site Public Contact
414-805-3666
Facility: Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
United States
Status: Recruiting Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Facility: Marshfield Clinic-Wausau Center
Wausau, Wisconsin 54401
United States
Status: Recruiting Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Facility: Marshfield Clinic - Weston Center
Weston, Wisconsin 54476
United States
Status: Recruiting Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org
Facility: Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin 54494
United States
Status: Recruiting Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org