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A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer

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ClinicalTrials.gov Identifier: NCT02448173
Recruitment Status : Recruiting
First Posted : May 19, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Vaccinogen Inc

Tracking Information
First Submitted Date  ICMJE May 6, 2015
First Posted Date  ICMJE May 19, 2015
Last Update Posted Date July 27, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
Disease-Free Survival [ Time Frame: Up to Five years ]
Defined as time from randomization to the date of the first objective test confirming tumor recurrence or death due to any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02448173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • Overall Survival [ Time Frame: Up to Five Years ]
    Defined as the time from randomization to death due to any cause
  • Recurrence-Free Interval [ Time Frame: Up to Five Years ]
    Defined as the time from randomization to the first objective test confirming tumor recurrence
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
Official Title  ICMJE A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
Brief Summary

OncoVAX® is the first cancer vaccine that both prevents cancer recurrence and

addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase

IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's

own cancer cells to mobilize the body's immune system to prevent the return of colon

cancer following surgery.

Detailed Description

OncoVAX is an active specific immunotherapeutic (ASI) stimulating a patient's immune

response to autologous (patient-specific) tumor cells. It is comprised of sterile, live but

non-dividing tumor cells obtained following standard-of-care surgical tumor resection for

Stage II colon cancer. Within 35 days following surgery, patients are immunized with

OncoVAX to prevent disease recurrence, which is incurable and occurs in up to 35% of

patients. Patients are given three vaccinations once per week for three weeks, followed

by a booster vaccination after six months. A previously completed Phase III trial

published in The Lancet showed that OncoVAX cut the risk of recurrence by 61% in

patients with Stage II colon cancer. The primary endpoint is Disease-Free Survival:

defined as the time from curative surgery to the objective test confirming tumor

recurrence or death due to any cause. The secondary endpoints are Overall Survival

and Recurrence-Free-Interval. An interim analysis will be performed at a significance

level of 0.005 once 2/3 of anticipated events have occurred, resulting in a significance

level of 0.0483 at the end of the study. A total of 550 patients is planned, randomized

1:1 to receive OncoVAX® plus surgery (n=275) or surgery alone (n=275).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stage II Colon Cancer
Intervention  ICMJE
  • Biological: OncoVAX and Surgery
    OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer
  • Procedure: Surgery
    Surgical resection of Stage II colon cancer
Study Arms  ICMJE
  • Experimental: OncoVAX and Surgery
    Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer
    Interventions:
    • Biological: OncoVAX and Surgery
    • Procedure: Surgery
  • Active Comparator: Surgery
    Surgical resection of Stage II colon cancer
    Intervention: Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2015)
550
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have Stage II (IIA = T3N0M0, IIB = T4aN0M0, IIC = T4bN0M0) disease.
  • Patients must have undergone curative resection and have no evidence of residual or metastatic disease.
  • Following curative resection patients must have a CEA within normal limits. If elevated prior to resection, it must return to normal within 21 days post surgery and prior to randomization.

Exclusion Criteria:

  • Patients with prior radiation therapy or chemotherapy or a prior malignancy of any type will be excluded. However, subjects with prior, curatively-treated squamous cell or basal cell carcinoma of the skin or carcinoma in situ of the cervix will be eligible for participation in this study.
  • Patients with more than one malignant primary colon cancer will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachel L Hoover, MS, MBA 410-387-4000 rhoover@vaccinogeninc.com
Contact: LaTonjia S Wallace, MS, MBA 410-387-4000
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02448173
Other Study ID Numbers  ICMJE ASI-2005-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vaccinogen Inc
Study Sponsor  ICMJE Vaccinogen Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael G Hanna, Jr, PhD Vaccinogen Inc
Study Director: Rachel L Hoover, MS, MBA Vaccinogen Inc
PRS Account Vaccinogen Inc
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP