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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):

Study Description
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.


Condition or disease Intervention/treatment Phase
Stage II Colon Cancer Biological: OncoVAX and Surgery Procedure: Surgery Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
Study Start Date : May 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022
Arms and Interventions

Arm Intervention/treatment
Experimental: OncoVAX and Surgery
Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer
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
Active Comparator: Surgery
Surgical resection of Stage II colon cancer
Procedure: Surgery
Surgical resection of Stage II colon cancer


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to Five Years ]
    Defined as the time from randomization to death due to any cause

  2. Recurrence-Free Interval [ Time Frame: Up to Five Years ]
    Defined as the time from randomization to the first objective test confirming tumor recurrence


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02448173


Contacts
Contact: Rachel L Hoover, MS, MBA 410-387-4000 rhoover@vaccinogeninc.com
Contact: LaTonjia S Wallace, MS, MBA 410-387-4000

Locations
United States, Florida
Halifax Health Medical Center Recruiting
Port Orange, Florida, United States, 32127
Contact: Ammar Hemaidan, MD         
Principal Investigator: Ammar Hemaidan, MD         
Sponsors and Collaborators
Vaccinogen Inc
Investigators
Study Chair: Michael G Hanna, Jr, PhD Vaccinogen Inc
Study Director: Rachel L Hoover, MS, MBA Vaccinogen Inc
More Information

Responsible Party: Vaccinogen Inc
ClinicalTrials.gov Identifier: NCT02448173     History of Changes
Other Study ID Numbers: ASI-2005-04
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases