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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Биопрепарат 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
• Процедура Surgery
  Surgical resection of Stage II colon cancer

Первичные конечные точки

• Disease-Free Survival [Срок оценки: Up to Five years]

Вторичные конечные точки (2)

• Overall Survival [Срок оценки: Up to Five Years]
• Recurrence-Free Interval [Срок оценки: Up to Five Years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Halifax Health Medical Center — Port Orange

Идентификаторы

NCT: NCT02448173 · ASI-2005-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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