A Phase 1/2 Study of HS-410 in Patients With High-Risk Non-Muscle Invasive Bladder Cancer After TURBT and BCG

This study is currently recruiting participants.
Verified April 2014 by Heat Biologics
Sponsor:
Information provided by (Responsible Party):
Heat Biologics
ClinicalTrials.gov Identifier:
NCT02010203
First received: December 5, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

This is a two-part study. The first stage will test the safety of HS-410 and the second stage will determine whether vaccination with HS-410 after transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG) extends the time to disease recurrence compared to placebo.


Condition Intervention Phase
Bladder Cancer
Drug: HS-410
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response and Clinical Activity of HS-410 in Patients With High-Risk Non-Muscle Invasive Bladder Cancer Who Have Undergone TURBT and Received Prior Treatment With Induction BCG

Resource links provided by NLM:


Further study details as provided by Heat Biologics:

Primary Outcome Measures:
  • Phase 1: Immune response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Immunologic response via intracellular cytokine staining (ICS) by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) on CD8+ cells after receiving 6 vaccine doses.

  • Phase 2: Time to Recurrence [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Tumor antigen expression analysis [ Time Frame: At screening ] [ Designated as safety issue: No ]
    Evaluation of pre-treatment tumor tissue for antigen expression

  • Tumor Infiltrating Lymphocytes (TILs) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Evaluation of post-treatment tumor tissue for the presence of infiltrating T-cells


Estimated Enrollment: 93
Study Start Date: December 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HS-410 Low Dose
HS-410 given as 1*10^6 cells for 12 weekly injections followed by 3 monthly injections open label in Phase 1 portion
Drug: HS-410
Vaccine derived from irradiated urothelial bladder cancer cells genetically engineered to continually secrete gp96
Experimental: HS-410 High-Dose
HS-410 given as 1*10^7 cells for 12 weekly injections followed by 3 monthly injections open label in the Phase 1 portion
Drug: HS-410
Vaccine derived from irradiated urothelial bladder cancer cells genetically engineered to continually secrete gp96
Experimental: HS-410 Phase 2 dose
Optimal dose of HS-410 from Phase 1 given as 12 weekly injections followed by 3 monthly injections randomized double-blind
Drug: HS-410
Vaccine derived from irradiated urothelial bladder cancer cells genetically engineered to continually secrete gp96
Placebo Comparator: Placebo
Placebo given as 12 weekly injections followed by 3 monthly injections randomized double-blind
Drug: Placebo
Injection containing sterile solution but no cells

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed or recurrent high grade non-muscle invasive bladder cancer with or without carcinoma in situ that has been removed by transurethral resection
  • Received 3-6 weekly doses of intravesical bacillus Calmette-Guérin (BCG) in the adjuvant setting
  • Adequate laboratory parameters
  • Bladder cancer risk assessment score >=8 on the recurrence scale and <=18 on the progression scale

Exclusion Criteria:

  • Prior immunologic or biologic response modifier therapy for treatment of this occurrence
  • Recurrence <12 months from most recent prior transurethral resection of bladder tumor (TURBT)
  • Prior immunologic, biologic response modifier, chemotherapy, radiation, or therapy for treatment of this occurrence
  • Intercurrent autoimmunity or immunodeficiency syndromes
  • Significant cardiac impairment
  • Other malignancies within the last 3 years
  • Known allergy to soy or egg products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02010203

Contacts
Contact: Melissa Price, PhD 919-240-7133 mprice@heatbio.com
Contact: Jennifer Kelley 919-240-7133 jkelley@heatbio.com

Locations
United States, Colorado
Urology Center of Colorado Recruiting
Denver, Colorado, United States, 80211
Contact: Judy Gibson    303-421-5783    jgibson@tucc.com   
Principal Investigator: Larry Karsh, MD         
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: MaryAnn Schroder    773-834-9198    mschroder@surgery.bsd.uchicago.edu   
Principal Investigator: Gary Steinberg, MD         
United States, Indiana
First Urology Recruiting
Jeffersonville, Indiana, United States, 47130
Contact: Christina Dallas    812-288-2611    cdallas@1sturology.com   
Principal Investigator: James Bailen, MD         
United States, North Carolina
University of North Carolina Chapell Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Madeline Carroll    919-843-5199    madeline_carroll@med.unc.edu   
Principal Investigator: Michael Woods, MD         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Michelle Allen    843-449-1010 ext 265      
Principal Investigator: Neal Shore, MD         
Sponsors and Collaborators
Heat Biologics
Investigators
Principal Investigator: Gary Steinberg, MD University of Chicago
  More Information

No publications provided

Responsible Party: Heat Biologics
ClinicalTrials.gov Identifier: NCT02010203     History of Changes
Other Study ID Numbers: HS410-101
Study First Received: December 5, 2013
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Heat Biologics:
TURBT
Bladder
Cancer
GP96
Vaccine
Immunotherapy
Heat Biologics
BCG
Bacillus Calmette-Guerin

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014