Unbounded innovation
Roswell Park’s Cuban collaboration

CIMAvax-EGF 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. In 2017, Roswell Park initiated a clinical trial involving CIMAvax. Our trial is a Phase I/II study of CIMAvax-EGF in combination with the anti-PD1 checkpoint inhibitor nivolumab (Opdivo®) in patients previously treated for advanced non-small cell lung cancer (NSCLC).

Another trial is testing CIMAvax-EGF for the prevention of lung cancer in patients who are at high risk or to prevent recurrence of lung cancer.

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 up to 175 patients with either:

• Advanced recurrent head and neck squamous cell carcinoma (HNSCC)
• Advanced (Stage IIB/IV) non-small cell lung cancer (NSCLC)

In addition to CIMAvax-EGF, patients will also receive the FDA-approved dose of nivolumab, for HNSCC, or pembrolizumab, for NSCLC.

Inclusion criteria include (but are not limited to):

• Adults with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC) or advanced recurrent head and neck squamous cell carcinoma (HNSCC)
• Must be eligible for treatment with nivolumab or pembrolizumab as standard of care
• Have a life expectancy of at least 6 months
• Have a patient performance status (ECOG) of ≤ 1 (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):

• Recent treatment with investigational agents
• Presence of a genetic/tumor mutation that has not been treated with an approved targeted therapy
• 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 or autoimmune disease, active cardiac disease, history of cardiac dysfunction, clinically serious infection, or other serious uncontrolled medical conditions
• History of myocarditis
• Pregnant or nursing

• Anyone between the ages of 50-79
• No evidence of cancer on a CT scan within 6 months

Inclusion criteria for high-risk group

• At least one risk factor for lung cancer
  • Moderate to severe COPD
  • Positive family history of lung cancer defined as a first degree relative
  • History of pneumonia within the last 5 years
  • Occupational exposure such as asbestos or radon
• Must have quit smoking less than 15 years ago or be a current smoker

Inclusion criteria for lung cancer survivor group

• Received surgery or any adjuvant therapy for initial diagnosis of lung cancer, it must have been completed at least 3 months prior to enrollment. Prior surgery or any therapy is not required for eligibility.
• Confirmed NSCLC stage IA to 3A at initial diagnosis and currently having no evidence of disease

Exclusion criteria for both groups

• Pregnant or nursing female participants
• Unable to have a bronchoscopy procedure
• History of an autoimmune disorder or known immunosuppressive disease

CIMAvax is currently available in the U.S. only to eligible patients accepted into Roswell Park’s clinical trial, which requires being in Buffalo, NY, for an extended period of time. Roswell Park is currently the only U.S. institution with clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical trials with this immunotherapy. There is work being done to bring this therapy to a larger population through other institutes. CIMAvax-EGF Clinical Trial: Find out if you’re eligible