Clinical Trial 18680

Cancer Type: Genitourinary
Interventions:ALT-803; BCG

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Wade Sexton

Overview

Study Title

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

Summary

The purposes of this research study are to find out the side effects of the study drug, ALT-803, plus BCG in Non-Muscle Invasive Bladder Cancer (NMIBC); find out how safe the study drug is and how well it is tolerated, and find out if the study drug plus Bacillus Calmette-Guerin (BCG) can stop the growth of the participant's tumor.

Objective

Primary Objectives: (1) Determination of MTD and designation of RD of ALT-803 in combination with BCG in patients who have non-muscle invasive bladder cancer (NMIBC). (2) Safety profile of BCG+ALT-803 in treated patients. (3) Disease response rate in treated patients. Secondary Objectives: (1) Immunogenicity and pharmacokinetic profiles of BCG+ALT-803 in treated patients. (2) Molecular alterations (e.g., assessed by immunohistochemistry and antibody-based immunoassays) in collected tissues (e.g., bladder tissue, blood and urine) will be noted during therapy and compared to prior therapy. (3) Recurrence-free survival, progression-free survival, overall survival, and duration of response of all treated patients.

Inclusion Criteria

  • Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-risk subtype. Patients are eligible if the diagnostic biopsy was done within 3 months (+ 2 week window) of treatment start and a cystoscopy demonstrates no gross disease within 4 weeks (+ 2 week window) of treatment start. High risk is defined as any high-grade Ta or T1, CIS.
  • Currently eligible for intravesical BCG therapy (34,35) (i.e. BCG naïve).
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Adequate laboratory test results within 14 days (+ 1 week window) of treatment start.
  • Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction.
  • Negative serum pregnancy test if female and of childbearing potential.
  • Female participants of childbearing potential must adhere to using a medically accepted method of birth control prior to screening and agree to continue its use during the study or be surgically sterilized and males must agree to use barrier methods of birth control while on study.
  • Provide signed informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations.
  • Additional criteria may apply.

  • Exclusion Criteria

  • Prior BCG treatment.
  • Concurrent use of other investigational agents.
  • Evidence of muscle-invasive bladder cancer or regional and/or distant metastasis.
  • New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction.
  • Symptomatic cogestive heart failure (CHF), severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
  • Marked baseline prolongation of QT/QTc interval (e.g., demonstration of a QTc interval greater than 500 milliseconds).
  • History or evidence of uncontrollable central nervous system (CNS) disease.
  • Known HIV-positive.
  • 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.
  • Women who are pregnant or nursing.
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Other illness that in the opinion of the investigator would exclude the patient from participating in this study.
  • Additional criteria may apply.