A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
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- STATUS
- Recruiting
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- days left to enroll
- 26
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- participants needed
- 550
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- sponsor
- Vaccinogen Inc
Summary
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.
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 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).
Details
| Condition | Stage II Colon Cancer |
|---|---|
| Treatment | Surgery, OncoVAX and Surgery |
| Clinical Study Identifier | NCT02448173 |
| Sponsor | Vaccinogen Inc |
| Last Modified on | 25 January 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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