Chronic Obstructive Pulmonary DiseaseEarly Phase 1NCT04298606
A Vaccine (CIMAvax-EGF) for the Prevention of Lung Cancer Development or Recurrence
A Early Phase 1 study testing Quality-of-Life Assessment, Questionnaire Administration and Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine in people with Chronic Obstructive Pulmonary Disease and Lung Non-Small Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Lung Non-Small Cell Carcinoma, Pneumonia
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2021to 6 Feb 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Must have documented pulmonary function test within the last 3 years prior to enrollment. If a patient cannot tolerate a pulmonary function test, an incentive spirometry will be acceptable in place of a pulmonary function test
- LUNG CANCER SURVIVOR COHORT ONLY (COHORT B)
- 1. If patient 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 non-small cell lung cancer (NSCLC) stage IA through 3A at initial diagnosis
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Phase 0 Study of CIMAvax-EGF Vaccine in Patients Who Are at High Risk for Lung Cancer and Lung Cancer Survivors at Risk for Recurrence
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of the vaccine based on circulating EGF and anti-EGF antibodies.
II. To access the molecular profile of blood, bronchial and nasal brushes, and bronchial biopsies to identify molecular markers associated with treatment and response.
III. To establish the safety of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax-EGF) treatment in cancer-free individuals using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 5).
SECONDARY OBJECTIVE:
- To evaluate quality of life score changes using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30) in patients who are at high risk for development of lung cancer or recurrence during CIMAvax-EGF treatment.
OUTLINE:
LOADING PHASE: Patients receive recombinant human EGF-rP64K/montanide ISA 51 vaccine intramuscularly (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 once every 4 weeks (Q4W) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 60 days.
- Conditions
- Chronic Obstructive Pulmonary Disease, Lung Non-Small Cell Carcinoma, Pneumonia, Stage IB Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Carcinoma, Non-Small-Cell Lung, Pneumonia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Recombinant Human EGF-rP64K/Montanide ISA 51 VaccineBiological
Also called Center of Molecular Immunology (CIMA) Epidermal Growth Factor (EGF) Vaccine, Center of Molecular Immunology Epidermal Growth Factor Vaccine, CimaVax, CIMAvax EGF
Given IM
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 60 days post treatment
Secondary outcomes (1)
Change in quality of life scores
Will be assessed using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30).
Measured: Baseline up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start22 Nov 2021
- Primary completion5 Dec 2025
- Study completion6 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Reid, PhD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298606
- Sponsor's protocol ID
- I 511919
- Other IDs
- NCI-2019-08720, I 511919
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2020
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No