A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence

NCT04298606 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: I 511919NCI-2019-08720
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This early phase I trial studies the side effects of a vaccine called CIMAvax-EGF and to see how well it works in preventing lung cancer from developing in patients at high risk for lung cancer or coming back (recurrence) in stage IB-IIIA non-small cell lung cancer survivors. In many cancers such as lung cancer, there is a protein receptor called EGFR (epidermal growth factor receptor) that is overexpressed within these cancers. Activation of EGFR has shown to lead to tumor growth and development. Previous studies have indicated that EGFR activation is present in the airways of cancer-free subjects as well. CIMAvax-EGF vaccine works by causing the body to make antibodies against EGF that is being produced that could be possibly driving the risk for developing cancer.

Conditions

Pneumonia; Chronic Obstructive Pulmonary Disease; Lung Non-Small Cell Carcinoma; Stage IB Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with antibody titers >= 1:4000 in response to vaccination

  The response to the vaccine will be measured using circulating EGF and anti-EGF antibodies replicating the results from the Cuban and Roswell trials. Human EGF will be determined by the Roswell Park Flow and Image Cytometry CCSG supported Resource using a commercial enzyme-linked immunosorbent assay (ELISA) assay (R\&D Systems, Minneapolis, MN). EGF antibodies will also be determined, by the Roswell Park Flow and Image Cytometry Resource using an in-house assay developed in cooperation with the Centro de Immunologia Molecular in La Habana, Cuba.

  Up to 60 days post treatment

• Molecular biomarker analysis

  Will access the molecular profile of blood, bronchial brushes, and bronchial biopsies to identify molecular markers associated with treatment and response. Biomarker scores will be analyzed for the molecular profile endpoint to test if they are significantly different post-treatment compared to pre-treatment (via paired t-test) or if a change in biomarker score (post-versus pre-) is significantly different among responders versus nonresponders (via t-test) as defined by histology and circulating levels of EGF ligand and anti-EGF antibodies. In addition to these biomarkers, gene expression signatures will be analyzed. These include gene expression signatures associated with EGFR activity, the high-grade lesion molecular subtype, and the immune-associated signature predictive of progressive/stable lesions compared with regressive lesions.

  Up to 60 days post treatment

• Number of patients with grade 3, 4 or 5 toxicities that are attributable to recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax)

  Measured according to Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. The plausible range for the true (unobserved) event rate will be estimated by the upper one-sided, 95% Jeffrey's interval.

  Up to 60 days post treatment

Secondary Outcomes (1)

• Change in quality of life scores

  Baseline up to 12 months

Study Arms (1)

Prevention (recombinant human EGF-rP64K/montanide ISA 51)

EXPERIMENTAL

LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM at 0, 2, 4 and 6 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine IM Q4W in the absence of disease progression or unacceptable toxicity.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Prevention (recombinant human EGF-rP64K/montanide ISA 51)

Questionnaire Administration OTHER

Ancillary studies

Prevention (recombinant human EGF-rP64K/montanide ISA 51)

Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine BIOLOGICAL

Given IM

Also known as: Center of Molecular Immunology (CIMA) Epidermal Growth Factor (EGF) Vaccine, Center of Molecular Immunology Epidermal Growth Factor Vaccine, CimaVax, CIMAvax EGF, CIMAvax Epidermal Growth Factor Vaccine, CimaVax Vaccine, CIMAvax-EGF, Recombinant Human EGF-P64K/Montanide Vaccine

Prevention (recombinant human EGF-rP64K/montanide ISA 51)

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed no evidence of cancer on computed tomography (CT) scan within 6 months prior to starting treatment
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Patients must have platelets \>= 100 x 10\^9/L
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry
• Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• PATIENTS AT HIGH-RISK FOR LUNG CANCER COHORT ONLY (COHORT A)
• Must have documented at least one risk factor for lung cancer which includes:
• Moderate to severe chronic obstructive pulmonary disease (COPD) defined as FEV1/FVC ratio \<=75%
• Positive family history of lung cancer defined as a first degree relative
• Low body mass index (BMI)
• History of pneumonia within the last 5 years prior to enrollment
• Occupational exposure such as asbestos, radon and any other that investigator would deem high risk
• Must have quit smoking =\< 15 years ago or be a current smoker
• Must have at least 30 pack year smoking history

You may not qualify if:

• Clinically inappropriate to have a bronchoscopy procedure
• Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, history of clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or nursing female participants
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
• Received an investigational agent within 30 days prior to enrollment
• Has known immunosuppressive disease (e.g. human immunodeficiency virus \[HIV\], acquired immunodeficiency syndrome \[AIDS\] or other immune depressing disease). Testing is not mandatory
• Patient has known hypersensitivity to the components of the study drugs or any analogs
• History of autoimmune disorder, with exception of patients with vitiligo or endocrine-related autoimmune conditions receiving appropriate hormonal supplementation who are eligible. Systemic use of immunosuppressant drugs such as steroids (except as hormone replacement therapy or short-course supportive medication such as chemotherapy or drug allergy, etc.), azathioprine, tacrolimus, cyclosporine, etc. within 4 weeks before recruitment
• The following special populations are excluded from this study:
• Cognitively impaired adults/adults with impaired decision-making capacity
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners
• Pregnant women

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Carcinoma, Non-Small-Cell Lung; Pneumonia; Lung Neoplasms

Interventions

CIMAvax EGF

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Infections; Infections

Study Officials

• Mary Reid, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: November 22, 2021
• Primary Completion: December 5, 2025
• Study Completion: February 6, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)