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

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ClinicalTrials.gov Identifier: NCT04298606
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

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.

Condition or disease Intervention/treatment Phase
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 Stage IIB Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Other: Quality-of-Life Assessment Other: Questionnaire Administration Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 22, 2021
Estimated Primary Completion Date : April 19, 2023
Estimated Study Completion Date : April 19, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prevention (recombinant human EGF-rP64K/montanide ISA 51)

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
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Biological: Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine
Given IM
Other Names:
  • 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




Primary Outcome Measures :
  1. Percentage of participants with antibody titers >= 1:4000 in response to vaccination [ Time Frame: Up to 60 days post treatment ]
    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.

  2. Molecular biomarker analysis [ Time Frame: Up to 60 days post treatment ]
    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.

  3. Number of patients with grade 3, 4 or 5 toxicities that are attributable to recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax) [ Time Frame: Up to 60 days post treatment ]
    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.


Secondary Outcome Measures :
  1. Change in quality of life scores [ Time Frame: Baseline up to 12 months ]
    Will be assessed using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298606


Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Mary Reid, PhD    716-845-1209    Mary.Reid@roswellpark.org   
Principal Investigator: Mary Reid, PhD         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Principal Investigator: Mary Reid, PhD Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT04298606    
Other Study ID Numbers: I 511919
NCI-2019-08720 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 511919 ( Other Identifier: Roswell Park Cancer Institute )
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Recurrence
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Monatide (IMS 3015)
Mitogens
Immunologic Factors
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic