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. (see Contacts and Locations)
Verified July 2014 by Heat Biologics
Sponsor:
Information provided by (Responsible Party):
Heat Biologics
ClinicalTrials.gov Identifier:
NCT02010203
First received: December 5, 2013
Last updated: July 8, 2014
Last verified: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, California
Skyline Urology Not yet recruiting
Torrance, California, United States, 90505
Contact: Stacey Gomez    818-990-5020    stacey.gomez@skyuro.com   
Principal Investigator: Frederick Wolk, MD         
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, Kansas
University of Kansas Cancer Center Not yet recruiting
Westwood, Kansas, United States, 66205
Contact: TBD         
Principal Investigator: Jeffery Holzbeierlein, MD         
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: TBD         
Principal Investigator: Trinity J Bivalacqua, MD, PhD         
United States, Massachusetts
University of Massachusetts Not yet recruiting
Worcester, Massachusetts, United States, 01655
Contact: Krystal Star    508-856-2424    krystal.starr2@umassmemorial.org   
Principal Investigator: Vijay Katsuri, 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         
United States, Texas
Urology of North Texas Not yet recruiting
Dallas, Texas, United States, 75231
Contact: Sharon Reeves    214-580-1482    reeves@urologyclinics.com   
Principal Investigator: James Cochran, 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: July 8, 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 August 01, 2014