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

NCT ID: NCT02448173

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-31
• Study Completion Date: 2033-08-31

Brief Summary

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.

Detailed 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 injections once per week for three weeks, followed

by a booster shot 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).

Conditions

Stage II Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OncoVAX and Surgery

Autologous Specific Immunotherapy given intradermally following surgical resection of Stage II colon cancer

Group Type: EXPERIMENTAL

OncoVAX and Surgery

Intervention Type: BIOLOGICAL

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

Surgery

Intervention Type: PROCEDURE

Surgical resection of Stage II colon cancer

Surgery

Surgical resection of Stage II colon cancer

Group Type: ACTIVE_COMPARATOR

Surgery

Intervention Type: PROCEDURE

Surgical resection of Stage II colon cancer

Interventions

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

Intervention Type: BIOLOGICAL

Surgery

Surgical resection of Stage II colon cancer

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vaccinogen Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael G Hanna, Jr, PhD

Role: STUDY_CHAIR

Vaccinogen Inc

Herbert C. Hoover, MD

Role: STUDY_DIRECTOR

Vaccinogen Inc

Locations

Halifax Health Medical Center

Port Orange, Florida, United States

Countries

United States

Central Contacts

Michael G Hanna, PhD

Role: CONTACT

active-trial@vaccinogentx.com

‪(347) 644-9396

LaTonjia S Wallace, MS, MBA

Role: CONTACT

Facility Contacts

Ammar Hemaidan, MD

Role: primary

Other Identifiers

ASI-2005-04

Identifier Type: -

Identifier Source: org_study_id