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

Stage II Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02448173
• Other study ID #: ASI-2005-04
• Status: Recruiting
• Phase: Phase 3
• First received: May 6, 2015
• Last updated: July 24, 2015
• Start date: May 2015
• Est. completion date: July 2022

Study information

• Verified date: July 2015
• Source: Vaccinogen Inc
• Contact: Rachel L Hoover, MS, MBA
• Phone: 410-387-4000
• Email: rhoover[@]vaccinogeninc.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: July 2022
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stage II Colon Cancer

Intervention

Biological:
• OncoVAX and Surgery
OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer

Procedure:
• Surgery
Surgical resection of Stage II colon cancer

Locations

Country	Name	City	State
United States	Halifax Health Medical Center	Port Orange	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vaccinogen Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Overall Survival	Defined as the time from randomization to death due to any cause	Up to Five Years	Yes
Secondary	Recurrence-Free Interval	Defined as the time from randomization to the first objective test confirming tumor recurrence	Up to Five Years	Yes