A Pivotal Phase IIIb Confirmatory Clinical Trial in Patients with Stage II Colon Cancer
Our upcoming Phase IIIb study – known as ACTIVE – will soon be enrolling 550 patients with stage II colon cancer, randomized 1:1 to receive surgery alone or surgery plus OncoVAX®. Patients will be followed on a regular schedule to determine if and when their cancer might return.
The FDA has agreed that the primary endpoint of ACTIVE is a statistically significant improvement in disease-free survival (DFS). Based on the average age of the population who will enter the study (65 years), this is the most appropriate endpoint to evaluate a trial in stage II colon cancer.
Based on previous experience (8701 Phase III study), stage II colon cancer patients who only received surgery recurred quicker and more frequently than patients who were treated with OncoVAX®.
If ACTIVE replicates the 8701 results, an interim analysis after 2/3 of the expected events (70 total instances of cancer recurrence or patient death) will be sufficient to provide a statistically significant difference in recurrence-free survival. Depending on the outcome, this could provide enough evidence to file a Biologics License Application (BLA) seeking marketing approval from the FDA.
Patients in either arm who experience disease recurrence will receive chemotherapy and other treatments for their metastatic disease. From a patient perspective, being disease-free is clearly a meaningful endpoint.
The ACTIVE protocol, including endpoints and statistical analysis plan, is the subject of a Special Protocol Assessment (SPA) and fast track review agreement granted by the FDA. An SPA provides a means for the trial sponsor and the FDA to reach an agreement on size, execution, and analysis of a clinical trial that is intended to form the primary basis for regulatory approval.
For more details regarding the ACTIVE Trial, please visit clinicaltrials.gov.