CIMAvax Lung Cancer Vaccine

Roswell Park has launched the first clinical trial in the United States to study the CIMAvax-EGF® vaccine, a lung cancer treatment that was developed in Cuba. We are the only facility in the country that offers this groundbreaking treatment.

Find Out If You Are Eligible

Frequently Asked Questions

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).

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.

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
  • 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
Roswell Park is the only U.S. institution with clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical trials with the vaccine. To get the vaccine, eligible patients need to be accepted into the trial and be willing to travel to Buffalo, NY, for an extended period of time.
The travel of all U.S. citizens to Cuba is strictly regulated by laws pertaining to the Embargo, and anyone planning travel to Cuba needs to first check these restrictions. U.S. health insurance is very unlikely to cover CIMAvax obtained in a foreign country. Roswell Park has no information on the specifics or advisability of receiving CIMAvax outside of the U.S.
Different insurance companies have different policies for covering care while on a clinical trial. CIMAvax will be provided free of charge by the CIM. Nivolumab is FDA-approved for treatment in this group of lung cancer patients, so that is standard of care, and billed to insurance.
Expanded access, sometimes called compassionate use, is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). No, we do not have a mechanism for Roswell Park to offer it as compassionate use.
In order to bring the vaccine to patients as quickly as possible, the Roswell Park Alliance Foundation is proud to commit $2.4 million in donor dollars to cover the cost of the initial clinical trials. These funds are raised through individual donations to Roswell Park and community fundraising events, including the foundation’s Ride For Roswell and Goin’ Bald For Bucks program. Learn how you can join the Alliance Foundation in supporting this effort.

Cuban Collaboration Timeline

Get the details about Roswell Park’s collaboration with Cuba’s Center for Molecular Immunology and our partnership in planning the U.S. clinical trial using CIMAvax-EGF, a lung cancer vaccine.

Vaccine Background

Additional Clinical Trials

NCI-supported clinical trials are offered at locations across the United States and Canada for both common and rare cancers. If you aren't eligible for the CIMAvax clinical trial, there may be a clinical trial better suited to your type of cancer.

Find an NCI Clinical Trial Find a Roswell Park Clinical Trial

Find out if you are eligible for the CIMAvax clinical trial.

Apply for the Trial

Help us bring the vaccine to lung cancer patients as quickly as possible.

Donate

Roswell Park experts are available for CIMAvax media inquiries.

Media Request

Cancer Talk Blogs About Vaccines

HPV vaccination is our best defense in stopping HPV infection in our youth and preventing HPV-associated cancers in our communities
Wednesday, January 11, 2017
Dr. Kelvin Lee provides an update on our agreement to bring CimaVax, Cuba's lung cancer vaccine, to the United States for clinical testing.
Monday, March 28, 2016

Cancer Vaccines in the News

Monday, November 14, 2016
Thursday, October 27, 2016
Wednesday, October 26, 2016