Clinical trial · Interventional
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
NCT02448173CI-TRIAL-00102229not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage II Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OncoVAX and Surgery | Biological | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OncoVAX and Surgery
- description
- Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer
- interventionNames
- Biological: OncoVAX and Surgery
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- Surgical resection of Stage II colon cancer
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
- measure
- Disease-Free Survival
- timeFrame
- Up to Five years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.