Description:
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.
Title
- 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
- Official 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
Clinical Trial IDs
- ORG STUDY ID:
CA-ALT-803-01-16
- NCT ID:
NCT03022825
Conditions
Interventions
Drug | Synonyms | Arms |
---|
ALT-803 | | BCG+ALT-803 |
BCG | | BCG+ALT-803 |
Purpose
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). 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 treatment in the maintenance treatment period at Months 6, 9 and 12. The
study duration is 24 months.
Trial Arms
Name | Type | Description | Interventions |
---|
BCG+ALT-803 | Experimental | | |
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
- Histologically confirmed presence of CIS (with or without Ta or T1 disease) or
histologically confirmed presence of high-grade Ta or T1 disease (without CIS)
- 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)
- BCG-unresponsive disease as defined as: (a) Persistent high-grade disease or
recurrence within 6 months of receiving at least two courses of intravesical BCG (at
least five of six induction doses and at least two of three maintenance doses); or (b)
T1 high-grade disease at the first evaluation following induction BCG alone (at least
5 of six induction doses)
- 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 > 6 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
- Evidence of muscle-invasive or regional and/or distant metastatic bladder cancer
- New York Heart Association (NYHA) Class III or IV heart failure or other clinical
signs of severe cardiac dysfunction
- Symptomatic congestive heart failure (CHF), 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Complete Response |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Assess incidence of complete response of CIS patients at six months. |
Secondary Outcome Measures
Measure: | Complete Response |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Assess durability of complete response at 12 months. |
Measure: | Complete Response |
Time Frame: | 18 months |
Safety Issue: | |
Description: | Assess durability of complete response at 18 months. |
Measure: | Complete Response |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Assess durability of complete response at 24 months. |
Measure: | Progression free survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Assess time from first treatment to disease progression |
Measure: | Overall Survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Assess time from first treatment to death resulting from any cause |
Measure: | Time to cystectomy |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Assess time from first treatment to cystectomy |
Measure: | Safety |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Assess incidence of adverse events |
Measure: | Quality of Life (QOL) |
Time Frame: | 24 months |
Safety Issue: | |
Description: | Compare changes in QOL scores from baseline |
Details
Phase: | Phase 2/Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Altor BioScience |
Trial Keywords
- BCG
- bladder cancer
- immunotherapy
- interleukin-15
- intravesical
- non-muscle invasive
Last Updated
November 10, 2017