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OncoVax for Stage II Colon Cancer

This study is testing OncoVax, a treatment that uses your own cancer cells to help your body's immune system fight against colon cancer coming back after surgery. It's for people with Stage II colon cancer who have had surgery and have no remaining cancer. The study aims to see if OncoVax can help you live longer without the cancer returning. To join, you must be at least 18 years old, have Stage II colon cancer, and have had successful surgery with normal CEA levels (a blood test marker). The study's status is currently unclear, and it plans to enroll 550 participants.

Study design
This is a randomized, multicenter study planning to enroll 550 participants. Half will receive OncoVax plus surgery, and the other half will receive surgery alone.
What's involved
If you receive OncoVax, you will get three injections once a week for three weeks, followed by a booster shot after six months. This treatment will be given within 35 days of your surgery.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how long you live without the disease returning for up to five years after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02448173

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

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
Vaccinogen Inc
~550 participants
Updated 2026-02-02 on ClinicalTrials.gov
What's tested:OncoVAX and SurgerySurgery

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-Free Survival
Measured over Up to Five years

Conditions

Stage II Colon Cancer

Explore related trials

Colon Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Michael G Hanna, Jr, PhD · STUDY_CHAIR · Vaccinogen Inc
  • Herbert C. Hoover, MD · STUDY_DIRECTOR · Vaccinogen Inc

Who to contact

Michael G Hanna, PhD
[email protected]
‪(347) 644-9396
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Disease-Free SurvivalUp 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