Unbounded Innovation: Roswell Park’s Cuban Collaboration
Through an historic partnership with Cuba’s Centro de Inmunología Molecular, or CIM, Roswell Park is helping to develop several innovative and potentially life-saving cancer therapies. The first of these new approaches to be available to U.S. patients is CIMAvax-EGF®, an immunotherapy for lung cancer. We are the only facility in the country that offers this groundbreaking treatment.
Frequently Asked Questions
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. CIMAvax blocks EGF by manipulating the patient’s immune response.
A “carrier protein” in CIMAvax 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 5,000 lung cancer patients have been treated with this unique immunotherapy, and several international studies have indicated prolonged tumor stabilization and improved overall survival and quality of life for patients receiving CIMAvax. CIMAvax is an approved treatment for lung cancer in Argentina, Bosnia and Herzegovina, Colombia, Cuba, Kazakhstan, Paraguay and Peru.
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 and progressed during or after platinum-based therapy, 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)