Clinical trial NCT02448173: A Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
Official title: A Randomized Multicenter Study of Active Specific Immunotherapy With OncoVax® in Patients With Stage II Colon Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stage II Colon Cancer
Lead sponsor: Vaccinogen Inc
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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).

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.

Primary outcomes:
measure: Disease-Free Survival
timeFrame: Up to Five years
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to Five Years
measure: Recurrence-Free Interval
timeFrame: Up to Five Years
Other outcomes:
Locations:
city: Port Orange
country: United States
facility: Halifax Health Medical Center
state: Florida
Study officials:
affiliation: Vaccinogen Inc
name: Michael G Hanna, Jr, PhD
role: STUDY_CHAIR
affiliation: Vaccinogen Inc
name: Rachel L Hoover, MS, MBA
role: STUDY_DIRECTOR
References: