Clinical Trials /

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

NCT04298606

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: I 511919
  • SECONDARY ID: NCI-2019-08720
  • SECONDARY ID: I 511919
  • SECONDARY ID: P30CA016056
  • NCT ID: NCT04298606

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
  • Stage IIB Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8

Interventions

DrugSynonymsArms
Recombinant Human EGF-rP64K/Montanide ISA 51 VaccineCenter 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 VaccinePrevention (recombinant human EGF-rP64K/montanide ISA 51)

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Prevention (recombinant human EGF-rP64K/montanide ISA 51)ExperimentalLOADING 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.
  • Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine

Eligibility 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 or legal representative 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)

               -  Positive family history of lung cancer

               -  Low body mass index (BMI)

               -  Recent pneumonia

               -  Occupational exposure such as asbestos, radon and any other that investigator
                  would deem high risk

          -  Must have quit smoking =< ten years ago or be a current smoker

          -  Must have at least 50 pack year smoking history

          -  Must have documented pulmonary function test within the last 3 years prior to
             enrollment

          -  LUNG CANCER SURVIVOR COHORT ONLY (COHORT B)

          -  Completion of adjuvant therapy after surgery at least 3 months prior to enrollment for
             lung cancer

          -  Confirmed non-small cell lung cancer (NSCLC) stage IB through 3A at initial diagnosis

        Exclusion Criteria:

          -  Clinically inappropriate to have a bronchoscopy procedure

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, 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
      
Maximum Eligible Age:79 Years
Minimum Eligible Age:50 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of participants with antibody titers >= 1:4000 in response to vaccination
Time Frame:Up to 60 days post treatment
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Change in quality of life scores
Time Frame:Baseline up to 12 months
Safety Issue:
Description:Will be assessed using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core 30 (C30).

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Roswell Park Cancer Institute

Last Updated

March 4, 2020