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

Study Overview
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Brief Summary
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OncoVAX® is the first cancer vaccine 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
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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 vaccinations once per week for three weeks, followed by a booster vaccination 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).

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

Conditions
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Stage II Colon Cancer

Intervention / Treatment
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* Biological: OncoVAX and Surgery
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OncoVAX and Surgery<br>Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer | Biological: OncoVAX and Surgery<br>* OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer<br>Procedure: Surgery<br>* Surgical resection of Stage II colon cancer<br>|
| Active Comparator: Surgery<br>Surgical resection of Stage II colon cancer | Procedure: Surgery<br>* Surgical resection of Stage II colon cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Defined as the time from randomization to death due to any cause | Up to Five Years | 
| Recurrence-Free Interval | Defined as the time from randomization to the first objective test confirming tumor recurrence | Up to Five Years |