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BRIEF TITLE: Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

  • Org Study ID: CA-ALT-803-01-14; QUILT-2.005
  • Secondary ID:
  • NCT ID: NCT02138734
  • NCT Alias:
  • Sponsor: Altor BioScience - Industry
  • Source: Altor BioScience

Brief Summary

This is a Phase Ib/IIb, randomized, open-label, multicenter study of intravesical ALT-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.

Detailed Description

The study includes a dose escalation phase (phase Ib) and an expansion phase (phase IIb).

In the phase Ib, patients will be treated with intravesical ALT-803 in combination with BCG.
The purpose of the phase Ib portion of the study is to evaluate the safety, identify the
Maximum Tolerated Dose (MTD) of ALT-803 and determine the Recommended Dose (RD) level of
ALT-803 in combination with BCG for the phase IIb expansion.

In the phase IIb expansion, patients will be randomized to receive either intravesical
ALT-803 in combination with BCG or BCG alone.

The purpose of the phase IIb portion of the study is to compare disease response, recurrence
and survival rates, safety and quality of life between the two treatment groups.

Overal Status Start Date Phase Study Type
Recruiting Start Date: July 2014 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Safety Profile

Primary Outcome 1 - Time Frame: 48 months

Primary Outcome 2 - Measure: MTD Determination

Primary Outcome 2 - Time Frame: 9 months

Primary Outcome 3 - Measure: Time to Recurrence

Primary Outcome 3 - Time Frame: 48 months

Primary Outcome 4 - Measure: RD Designation

Primary Outcome 4 - Time Frame: 9 months


  • Non-muscle Invasive Bladder Cancer




- Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell
carcinoma high-grade subtype.

- Patients are eligible if the diagnostic biopsy was done within 3 months of
treatment start and a cystoscopy demonstrating no resectable disease was done
within 6 weeks of treatment start. Patients with high-grade Ta and/or T1 disease
should have complete resection before study treatment.

- Upper tract imaging within 6 months prior to study entry must not be suspicious
for upper tract malignancy.

- No history of or evidence of muscle-invasive, locally advanced, metastatic and/or
extravesical bladder cancer or presence of any other cancer.


- No prior BCG treatment or known hypersensitivity to BCG. Patients who have received
more than a single-dose post-operative treatment of mitomycin-C or gemcitabine are

- No concurrent use of other investigational agents.


Performance Status • ECOG 0, 1, or 2. Bone Marrow Reserve

- Absolute neutrophil count (AGC/ANC) ≥ 1,000/uL

- Platelets ≥ 100,000/uL

- Hemoglobin ≥ 8g/dL Renal Function

- Glomerular Filtration Rate (GFR) > 40mL/min or serum creatinine ≤ 1.5 x ULN Hepatic

- Total bilirubin ≤ 2.0 X ULN

- AST, ALT, ALP ≤ 3.0 X ULN Cardiovascular

- No symptomatic congestive heart failure Class III or IV.

- No severe/unstable angina pectoris < 6 months.

- No myocardial infarction < 6 months. Pulmonary

- Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction.


- Currently eligible for intravesical BCG therapy.

- Negative serum pregnancy test if female and of childbearing potential.

- No women who are pregnant or nursing.

- Subjects, both females and males, with reproductive potential must agree to use
effective contraceptive measures for the duration of the study.

- No known positive HIV status.

- No history or evidence of uncontrollable CNS disease.

- No psychiatric illness/social situation that would limit compliance with study

- No other illness that in the opinion of the investigator would exclude the patient
from participating in this study.

- Must provide signed informed consent and HIPPA authorization and agree to comply with
all protocol-specified procedures and follow-up evaluations.

- No active systemic infection requiring parenteral antibiotic therapy.

- No ongoing chronic systemic steroid therapy required.

- No concurrent febrile illness, active urinary tract infection, active tuberculosis, a
history of hypotension or anaphylactic reactions.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Amy Rock, PhD

Role: Study Director

Affiliation: Altor BioScience

Overall Contact

Name: Clare Rigby, BA

Phone: (954) 443-8600



Facility Status Contact
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Recruiting Ralee' Bishop Bunt
Alaska Clinical Research Center
Anchorage, Alaska 99503
United States
Recruiting Lisa Adams, RMA
UCLA Department of Urology
Los Angeles, California 90024
United States
Recruiting Ankush Sachdeva
University of California, Davis
Sacramento, California 95817
United States
Recruiting Randev Sandhu
Skyline Sherman Oaks
Sherman Oaks, California 91411
United States
Recruiting Stacey Gomez
Skyline Urology
Torrance, California 90505
United States
Recruiting Stacey Gomez
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut 06360
United States
Recruiting Susan Johnson
Moffitt Cancer Center
Tampa, Florida 33612
United States
Recruiting Yazmin Rodriguez, MD
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United States
Recruiting Emily Hui
Kansas University Medical Center
Westwood, Kansas 66205
United States
Recruiting Christina Hopkins
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Veena Ramakrishna
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Recruiting Darcie l Findley
Winthrop University Hospital
Mineola, New York 11501
United States
Recruiting Amanda Le Sueur, PhD
University of Washington School of Medicine
Seattle, Washington 98109
United States
Recruiting Alexandria z Lahdya