NCT02448173

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Vaccinogen Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-08-01
• Primary completion: 2031-08-01
• Completion: 2033-08-01
• First posted: 2015-05-19
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study