Stage II Colon CancerPhase 3NCT02448173
A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
A Phase 3 study testing OncoVAX and Surgery and Surgery in people with Stage II Colon Cancer, run by Vaccinogen Inc at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II Colon Cancer
- What is being tested?
- OncoVAX and Surgery and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
LaTonjia S Wallace, MS, MBA contact
United States1 site
Halifax Health Medical Center
Port Orange, Florida, 32127
Ammar Hemaidan, MD
Ammar Hemaidan, MD
About this study
Official title: 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.
Read the 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).
- Conditions
- Stage II Colon Cancer
- Being tested
- OncoVAX and Surgery, Surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoVAX and SurgeryBiological
OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer
SurgeryProcedure or surgery
Surgical resection of Stage II colon cancer
| Study group | Role | What they receive |
|---|---|---|
| OncoVAX and Surgery | Experimental | Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer Receives: Biological: OncoVAX and Surgery; Procedure: Surgery |
| Surgery | Active comparator | Surgical resection of Stage II colon cancer Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival
Defined as time from randomization to the date of the first objective test confirming tumor recurrence or death due to any cause
Measured: Up to Five years
Secondary outcomes (2)
Overall Survival
Defined as the time from randomization to death due to any cause
Measured: Up to Five Years
Recurrence-Free Interval
Defined as the time from randomization to the first objective test confirming tumor recurrence
Measured: Up to Five Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startAug 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vaccinogen Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael G Hanna, Jr, PhD, Study chair, Vaccinogen IncHerbert C. Hoover, MD, Study director, Vaccinogen Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448173
- Sponsor's protocol ID
- ASI-2005-04
- Status last verified
- Jan 2026
- First submitted
- 6 May 2015
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
- ClinicalTrials.gov ID
- NCT02448173
- Acronym / sponsor ID
- ASI-2005-04
- Conditions
- Stage II Colon Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Vaccinogen IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2033 (estimated)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OncoVAX and Surgery | Experimental | Biological: OncoVAX and Surgery, Procedure: SurgeryAutologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer |
| Surgery | Active comparator | Procedure: SurgerySurgical resection of Stage II colon cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoVAX and SurgeryOncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer | Biological | OncoVAX and Surgery |
| SurgerySurgical resection of Stage II colon cancer | Procedure or surgery | OncoVAX and Surgery, Surgery |
Primary outcome
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
2 secondary outcomes
Overall Survival
Time frame: Up to Five Years
Recurrence-Free Interval
Time frame: Up to Five Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LaTonjia S Wallace, MS, MBA contact
Michael G Hanna, Jr, PhD study chair
Vaccinogen Inc
Herbert C. Hoover, MD study director
Vaccinogen Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OncoVAX and Surgery and Surgery in people with Stage II Colon Cancer, run by Vaccinogen Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael G Hanna, PhD ((347) 644-9396, active-trial@vaccinogentx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (time frame: Up to Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.