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

  • STATUS
    Recruiting
  • End date
    Jul 21, 2022
  • participants needed
    550
  • sponsor
    Vaccinogen Inc
Updated on 21 January 2021

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 IdentifierNCT02448173
SponsorVaccinogen Inc
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Stage II Colon Cancer?
Do you have any of these conditions: Do you have Stage II Colon Cancer??
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
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If 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.

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