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

January 29, 2026 updated by: Vaccinogen Inc

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

OncoVAX® is the first cancer therapy 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 injections once per week for three weeks, followed

by a booster shot 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

Interventional

Enrollment (Estimated)

550

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: LaTonjia S Wallace, MS, MBA

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Port Orange, Florida, United States, 32127
        • Halifax Health Medical Center
        • Contact:
          • Ammar Hemaidan, MD
        • Principal Investigator:
          • Ammar Hemaidan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to Five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Up to Five Years
Defined as the time from randomization to death due to any cause
Up to Five Years
Recurrence-Free Interval
Time Frame: Up to Five Years
Defined as the time from randomization to the first objective test confirming tumor recurrence
Up to Five Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vaccinogen Inc

Investigators

  • Study Chair: Michael G Hanna, Jr, PhD, Vaccinogen Inc
  • Study Director: Herbert C. Hoover, MD, Vaccinogen Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2033

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimated)

May 19, 2015

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASI-2005-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stage II Colon Cancer

Clinical Trials on OncoVAX and Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe