CIMAvax-EGF vaccine is a lung cancer treatment that was developed in Cuba. It is a type of immunotherapy that harnesses the body’s immune system to fight lung cancer. Our trial is a Phase I/II study of the CIMAvax-EGF vaccine in combination with the Anti-PD1 checkpoint inhibitor nivolumab (Opdivo®) in patients previously treated for advanced non-small cell lung cancer (NSCLC).
How does it work?
Developed by researchers at the Center for Molecular Immunology (CIM) in Havana, Cuba, CIMAvax-EGF blocks a type of protein—epidermal growth factor (EGF)—that cancer cells need to grow. It does not kill cells directly, cancerous cells or otherwise, but “starves” them by preventing EGF from attaching to its proper receptor (EGFR) on the cell.
This connection is required for the cell to grow and proliferate. Without it, the cancer cell does not multiply, and dies. This vaccine blocks EGF by manipulating the patient’s immune response.
The vaccine agent is coupled to a “carrier protein” that further stimulates the immune response, and triggers the immune system to produce antibodies against the EGF protein to neutralize it. This depletes circulating EGF from the blood, depriving the cancer cells of this important key to growth and survival.
More than 4,000 lung cancer patients have been treated with this vaccine in worldwide clinical trials, and results indicate prolonged tumor stabilization and significantly improved overall survival and quality of life. The vaccine is approved by CECMED, Cuba’s FDA-equivalent agency. The vaccine is approved for the treatment of lung cancer in Bosnia and Herzegovina, Colombia, Cuba, Paraguay and Peru.
Who is eligible for this trial?
This trial will enroll approximately 60 to 90 patients with advanced (Stage IIIB/IV) non-small cell lung cancer (NSCLC) whose disease has progressed during or after first-line systemic chemotherapy, including targeted therapy. Patients will also receive the FDA-approved dose of nivolumab, the standard-of-care second-line therapy for NSCLC.
Inclusion criteria include (but are not limited to):
Adults with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC)
Previously treated with first-line systemic chemotherapy, including targeted therapy, for advanced NSCLC
Must be eligible for treatment with nivolumab as standard of care
Have a life expectancy of at least 6 months
Have a patient performance status (ECOG) of ≤ 2 (patient is ambulatory; capable of all self care, but unable to carry out any work activities; up and about more than 50% of waking hours)
Exclusion criteria include (but are not limited to):
Previously treated with immunotherapy or investigational agents in last 6 months
Any mutation that can be treated with targeted therapy
Any history of cardiac surgeries. ie stents, valve replacement
Use of immunosuppressant drugs (steroids, azathioprine, tacrolimus, cyclosporine, etc.) in last month
Currently receiving or has received systemic corticosteroids within 4 weeks of beginning study drug, or has not recovered fully from side effects of such treatment.
Major surgery within last 14 days, or has not recovered from major side effects of prior surgery (tumor biopsy not considered major surgery)
Known immunosuppressive disease, active cardiac disease, history of cardiac dysfunction, clinically serious infection, or other serious uncontrolled medical conditions
Pregnant or nursing
Any history of cardiac surgeries (ex: stents, valve replacement).
Source: Roswell Park Cancer Institute