SUPPORT HOTLINE (888) 901-2226
Donate Now

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
  • Secondary ID:
  • NCT ID: NCT02138734
  • NCT Alias:
  • Sponsor: Altor Bioscience Corporation - Industry
  • Source: Altor Bioscience Corporation

Brief Summary

This is a Phase Ib/II, open-label, dose-finding, multicenter study of intravesical BCG plus ALT-803 in Non-muscle invasive bladder cancer.

Detailed Description

The purpose of this 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 combined with BCG
in patients who have nonmuscle invasive bladder cancer. The anti-tumor activity of
BCG+ALT-803 will also be assessed. In addition, the study will characterize the molecular,
immunogenicity and pharmacokinetic profile of BCG+ALT-803.

The study includes a dose escalation phase (Phase Ib) and an expansion phase (Phase II). The
dose escalation phase is concluded when the MTD is determined. A dose level (RD) will be
designated for the phase II study. For the noncomparative randomized phase II, patients will
be randomized to two treatment arms: either ALT-803 at the RD level in combination with BCG
(50 mg) or BCG (50 mg) alone.

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 and RD Designation

Primary Outcome 2 - Time Frame: 9 months


  • Non-muscle Invasive Bladder Cancer




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

◦High risk is defined as any high-grade Ta or T1, CIS.

- No evidence of muscle-invasive bladder cancer or regional and/or distant metastasis.


- No prior BCG treatment.

- 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 Function

- Total bilirubin ≤ 2.0 X ULN

- AST, ALT, ALP ≤ 3.0 X ULN


- No symptomatic congestive heart failure < 6 months.

- No severe/unstable angina pectoris < 6 months.

- No myocardial infarction < 6 months.

- No NYHA Class > II.

- No marked baseline prolongation of QT/QTc interval.


• 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 autoimmune disease other than corrected hypothyroidism (for phase Ib only).

- No prior organ allograft or allogeneic transplantation (for phase Ib only).

- 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.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Hing C Wong, PhD

Role: Study Chair

Affiliation: Altor Bioscience Corporation


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 Nazy Zomorodian, NP
University of California, Davis
Sacramento, California 95817
United States
Recruiting Charleen McDaniel
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 Cortlin Croft
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United States
Recruiting Isobel Webster
Kansas University Medical Center
Westwood, Kansas 66205
United States
Recruiting Christina Hopkins
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Tamara Dimovski
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Recruiting Darcie l Findley
Winthrop University Hospital
Mineola, New York 11501
United States
Recruiting Kaitlin Kosinski, MS
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Recruiting Cheryl Eitman
University of Washington School of Medicine
Seattle, Washington 98109
United States
Recruiting Alexandria z Lahdya