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Brief Title: QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: CA-ALT-803-01-16
  • Secondary ID: N/A
  • NTC ID: NCT03022825
  • Sponsor: ImmunityBio, Inc.

BRIEF SUMMARY

This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. The study duration is 24 months.

  • Overall Status
    Recruiting
  • Start Date
    June 2, 2017
  • Phase
    Phase 2, Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete Response

Primary Outcome 1 - Timeframe: 24 Months

Primary Outcome 2 - Measure: Disease-Free Rate

Primary Outcome 2 - Timeframe: 12 Months

CONDITION

  • Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
Male or female patients 18 years of age or older

- Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).

- Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease.

- Absence of resectable disease after transurethral resection (TURBT) procedures (residual carcinoma in situ (CIS) acceptable; patients with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] if initial biopsy did not include muscularis propria). Patients with high-grade Ta and/or T1 disease should have complete resection before study treatment.

- BCG-unresponsive disease as defined as: (a) Persistent or recurrent CIS (+/- recurrent Ta/T1 disease) within 12 months of receiving adequate BCG (at least five of six doses doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course); or (b) Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG (at least five of six doses of an initial induction course plus either at least two of three doses of maintenance therapy or at least two of six doses of a second induction course); or (c) T1 high-grade disease at the first evaluation following an induction BCG course alone (at least five of six doses of an initial induction course).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
Exclusion Criteria:
Recurrence of BCG unresponsive Ta/T1 disease (without presence of CIS) > 6 months after last BCG instillation or BCG unresponsive CIS > 12 months after last BCG instillation.

- Life expectancy <2 years - Any of the following clinical laboratory values at the time of enrollment: (1) Absolute neutrophil count (ANC) <800/µL or (2) Platelets < 50,000/µL - Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (AST or ALT) >2 times upper limit of normal (ULN)

- Renal insufficiency as indicated by a creatinine level >3 times ULN

- History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer; or any other cancer within the past 5 years, except: 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 stable prostate cancer (under active surveillance or hormone control).

- Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction

- Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry

- History or evidence of uncontrollable central nervous system (CNS) disease

- Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy

- Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions

- Ongoing chronic systemic steroid therapy required (>10 mg oral prednisone daily or equivalent)

- Women who are pregnant or nursing. Female patients of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.

- Patients currently receiving investigational or commercial anti-cancer agents or anti-cancer therapies other than BCG, ALT-803 and supportive care therapies for active disease.

- Concurrent use of other investigational agents

- Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the patient from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Karim Chamie, MD

Role: Principal Investigator

Affiliation: University of California, Los Angeles

Overall Contact

Name: Karim Chamie, MD

Phone: (704) 488-8192

Email: sharon.khadaran@immunitybio.com, liza.hochoa@immunityBio.com

LOCATION

Facility Status Contact
Facility: Arkansas Urology
Little Rock, Arkansas 72211
United States
Status: Recruiting Contact: Principal Investigator
Richard D'Anna, MD
310-794-3421 107
ASachdeva@mednet.ucla.edu
Facility: UCLA Department of Urology
Los Angeles, California 90024
United States
Status: Recruiting Contact: Principal Investigator
Karim Chamie, MD
305-243-2177
rxb773@med.miami.edu
Facility: Hoag Memorial Hospital
Newport Beach, California 92663
United States
Status: Recruiting Contact: Contact
Leila Andres
954-941-3330
jptalis@ucfla.com
Facility: University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
Status: Recruiting Contact: Principal Investigator
Steven Kester, MD
505-872-4091
eshowen@accumentrx.com
Facility: Clinical Research Center of Florida
Pompano Beach, Florida 33060
United States
Status: Recruiting Contact: Contact
Austin Lannon
716-845-8730
Sreejeta.Dasgupta@RoswellPark.org
Facility: Moffit Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact: Principal Investigator
Wade J Sexton, MD
516-535-4187
Mary.Palmer@nyulangone.org
Facility: University of Michigan
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Principal Investigator
Michael L Cher, MD
919-758-7386
kmoffett@auncurology.com
Facility: Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Status: Recruiting Contact: Contact
Kayla Bowles, RN
215-503-3754
Katherine.Burns@jefferson.edu
Facility: Adult & Pediatric Urology
Omaha, Nebraska 68114
United States
Status: Recruiting Contact: Principal Investigator
Andrew Trainer, MD
615-343-2120
pamela.steele@vanderbilt.edu
Facility: Accument Rx
Albuquerque, New Mexico 87109
United States
Status: Recruiting Contact: Contact
Erin Showen
804-288-2785
clrose@uro.com
Facility: Roswell Park Cancer Insitute
Buffalo, New York 14263
United States
Status: Recruiting Contact: Principal Investigator
Fred Snoy, MD
253-968-2300
drew.m.thomas2.ctr@mail.mil
Facility: Winthrop University Hospital Department of Urology
Garden City, New York 11530
United States
Status: Recruiting Contact: Contact
Sreejeta Dasgupta

Facility: Manhattan Medical Research
New York, New York 10016
United States
Status: Recruiting Contact: Principal Investigator
Khurshid Guru, MD

Facility: Premier Medical Group of the Hudson Valley
Poughkeepsie, New York 12601
United States
Status: Recruiting Contact: Contact
Mary Palmer, PhD

Facility: UNC Chapel Hill
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Carmela Graci-Pipitone, RN

Facility: Associated Urologists of North Carolina
Raleigh, North Carolina 27612
United States
Status: Recruiting Contact: Principal Investigator
Jed Kaminetsky, MD

Facility: Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: Contact
Christopher Paterno, RN

Facility: Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: Principal Investigator
Hung-Jui Tan, MD

Facility: Virginia Urology
Richmond, Virginia 23235
United States
Status: Recruiting Contact: Contact
Kiplyne Moffett

Facility: Madigan Army Medical Center
Tacoma, Washington 98431
United States
Status: Recruiting Contact: Principal Investigator
Mark W Jalkut, MD