A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
1 other identifier
interventional
550
1 country
1
Brief 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 the return of colon cancer following surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2026
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2031
Study Completion
Last participant's last visit for all outcomes
August 1, 2033
February 2, 2026
January 1, 2026
5 years
May 6, 2015
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Up to Five years
Secondary Outcomes (2)
Overall Survival
Up to Five Years
Recurrence-Free Interval
Up to Five Years
Study Arms (2)
OncoVAX and Surgery
EXPERIMENTALAutologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer
Surgery
ACTIVE COMPARATORSurgical resection of Stage II colon cancer
Interventions
OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer
Eligibility Criteria
You 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 may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vaccinogen Inclead
Study Sites (1)
Halifax Health Medical Center
Port Orange, Florida, 32127, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael G Hanna, Jr, PhD
Vaccinogen Inc
- STUDY DIRECTOR
Herbert C. Hoover, MD
Vaccinogen Inc
Central Study Contacts
LaTonjia S Wallace, MS, MBA
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2015
First Posted
May 19, 2015
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
August 1, 2031
Study Completion (Estimated)
August 1, 2033
Last Updated
February 2, 2026
Record last verified: 2026-01