What this study is
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.
What's being tested
- OncoVAX and Surgery
Intervention · BIOLOGICAL
OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer
- Surgery
Intervention · PROCEDURE
Surgical resection of Stage II colon cancer
Study details
- Official title
- A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
- Sponsor
- Vaccinogen Inc
- Conditions
- Stage II Colon Cancer
- Enrolling
- 550 people
- Starts
- 2026-08
- Est. completion
- 2033-08
- Design
- Open-label, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHalifax Health Medical Center
Port Orange, Florida, United States
- Ammar Hemaidan, MD · Contact
- Ammar Hemaidan, MD · Principal investigator
Study team
Sponsor
Vaccinogen Inc
Study ID ASI-2005-04
Study chair
Michael G Hanna, Jr, PhD
Vaccinogen Inc
Study director
Herbert C. Hoover, MD
Vaccinogen Inc
CONTACT
LaTonjia S Wallace, MS, MBA
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.