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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


  • Org Study ID: CA-ALT-803-01-16
  • Secondary ID:
  • NCT ID: NCT03022825
  • NCT Alias:
  • Sponsor: Altor BioScience - Industry
  • Source: Altor BioScience

Brief Summary

This is a Phase II, open-label, single-arm, multicenter study of intravesical BCG plus ALT-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 ALT-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.

Overal Status Start Date Phase Study Type
Recruiting June 2, 2017 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Complete Response

Primary Outcome 1 - Time Frame: 24 Months

Condition:

  • Bladder Cancer

Eligibility

Criteria:
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 presence of any other cancer.

- 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.

- 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.
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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: Amy Rock, PhD

Phone: 954-443-8600

Email: amyrock@altorbioscience.com

Locations

Facility Status Contact
The University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Not yet recruiting Dorothy Butler
205-934-2272
dybutler@uabmc.edu
Alaska Clinical Research Center
Anchorage, Alaska 99503
United States
Recruiting Lisa Adams, RMA
907-276-1455
LAdams@akmed.com
Seton Medical Center
Daly City, California 94015
United States
Not yet recruiting Laurie Lee
650-991-6756
laurielee@verity.org
West Coast Urology
Inglewood, California 90301
United States
Recruiting Tiffany Aynehchi
310-673-3333
Tiffany@westcoasturology.com
UCLA Department of Urology
Los Angeles, California 90024
United States
Recruiting Ankush Sachdeva
310-794-3421
ASachdeva@mednet.ucla.edu
Skyline Urology
Sherman Oaks, California 91411
United States
Recruiting Stacey M Gomez
310-602-5018
stacey.gomez@skyuro.com
Skyline Urology
Torrance, California 90505
United States
Recruiting Stacey M Gomez
310-602-5018
stacey.gomez@skyuro.com
Urology Associates, PC
Englewood, Colorado 80113
United States
Recruiting Lenden Neeper
303-733-8848
L.Neeper@uradenver.com
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut 06360
United States
Recruiting Nancy Wilcox, RN
860-886-8362
nwilcox@echoct.com
University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center
Miami, Florida 33136
United States
Recruiting Rody Barakat
305-243-2177
rxb773@med.miami.edu
Dwight D. Eisenhower Army Medical Center
Augusta, Georgia 30905
United States
Not yet recruiting Elsa Salazar
706-787-5811
elsa.c.salazar2.ctr@mail.mil
University of Hawaii Cancer Center
Honolulu, Hawaii 96814
United States
Recruiting Thomas Syverson
808-440-4569
TSyverson@cc.hawaii.edu
Tripler Army Medical Center
Kailua, Hawaii 96734
United States
Not yet recruiting Nina Bermudez
808-433-2972
nina.o.bermudez.ctr@mail.mil
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Not yet recruiting Benas Jakubauskas
773-702-3080
bjakubauskas@medicine.bsd.uchicago.edu
University of Kansas Cancer Center
Westwood, Kansas 66205
United States
Not yet recruiting Christina Hopkins
913-588-2566
Chopkins2@kumc.edu
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Tamara Dimovski
313-576-9771
dimovskt@karmanos.org
Adult & Pediatric Urology
Omaha, Nebraska 68114
United States
Not yet recruiting Amy Nelson
402-399-7893
anelson@adultpediatricuro.com
Roswell Park Cancer Insitute
Buffalo, New York 14263
United States
Recruiting Colleen Borsuk
716-845-1657
Colleen.borsuk@roswellpark.org
Winthrop University Hospital Department of Urology
Garden City, New York 11530
United States
Recruiting Amanda Le Sueur, PhD
516-535-4184
alesueur@NYUWinthrop.org
Manhattan Medical Research
New York, New York 10016
United States
Not yet recruiting Carmela Graci-Pipitone, RN
212-480-3333
cgpipitone@manhattanmedicalresearch.com
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York 12601
United States
Not yet recruiting Lisa Crespi, LPN
845-437-5010
mailto:lcrespi@premiermedicalhv.com
University of Rochester
Rochester, New York 14642
United States
Not yet recruiting Mare Perevich, RN
585-275-0989
mare_perevich@urmc.rochester.edu
UNC Chapel Hill
Chapel Hill, North Carolina 27599
United States
Not yet recruiting Christopher Paterno, RN
919-537-3505
christopher_paterno@med.unc.edu
Associated Urologists of North Carolina
Raleigh, North Carolina 27612
United States
Not yet recruiting Denise Capley
919-758-8677
dcapley@auncurology.com
Clinical Research Solutions
Middleburg Heights, Ohio 44130
United States
Recruiting Jennifer Kalapis
440-305-8150
JKalapis@crssites.com
Toledo Clinic
Toledo, Ohio 43606
United States
Recruiting Jennifer Martinez
419-479-5605
jmartinez@toledoclinic.com
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Not yet recruiting Katherine Burns
215-503-3754
Katherine.Burns@jefferson.edu
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Recruiting Pamela Steele, RN
615-343-2120
pamela.steele@vanderbilt.edu
William Beaumont Army Medical Center
El Paso, Texas 79920
United States
Not yet recruiting Melinda Abamukong
915-742-3432
MAbamukong@genevausa.org
Virginia Urology
Richmond, Virginia 23235
United States
Not yet recruiting Brittany P Quigley
804-288-2785
bpquigley@uro.com
Madigan Army Medical Center
Tacoma, Washington 98431
United States
Not yet recruiting Drew Thomas
253-968-2300
drew.m.thomas2.ctr@mail.mil