Clinical Trials /

Safety & Efficacy Study of EGF Cancer Vaccine to Treat Stage IV Biomarker Positive, Wild Type EGF-R NSCLC Patients

NCT02187367

Description:

The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase 3 trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type EGF-Receptor compared to standard treatment and supportive care.

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Safety & Efficacy Study of EGF Cancer Vaccine to Treat Stage IV Biomarker Positive, Wild Type EGF-R NSCLC Patients
  • Official Title: Phase 3 Open-label, Multicentre, Randomised Trial to Establish Safety & Efficacy of an EGF Cancer Vaccine in Inoperable, Stage IV Biomarker Positive,Wild Type EGF-R NSCLC Patients Eligible to Receive Standard Treatment and Supportive Care

Clinical Trial IDs

  • ORG STUDY ID: BV-NSCLC-002
  • SECONDARY ID: 2013-005335-25
  • NCT ID: NCT02187367

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
EGF VaccineCyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51EGF Vaccine

Purpose

The vaccine contains humanized recombinant antigen (EGF - Epithelial Growth Factor) and an adjuvant. The antibodies induced by vaccination will react with circulating EGF leading to removal of EGF from the circulation. As a result, binding to its target EGF-Receptor is prevented. Blocking of EGF-Receptor is preventing activation and stimulation of proliferation of tumour cell. A Phase 3 clinical trial on the EGF vaccine is ongoing in Cuba. The result from previous studies demonstrated positive correlation between extended survival and immune response against the vaccination in the late-stage NSCLC patients' age below 60 with improved quality of life. The purpose of this international Phase 3 trial is to determine whether the recombinant human EGF cancer vaccine is safe, immunogenic and effective in the treatment of stage IV NSCLC patients who are positive in the selective EGF biomarker and wild type EGF-Receptor compared to standard treatment and supportive care.

Trial Arms

NameTypeDescriptionInterventions
EGF VaccineExperimentalPatients in this arm will receive a low dose of cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51
  • EGF Vaccine
Best Supportive CareNo InterventionPatients in this arm will receive best supportive care

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Are aged 18 or older.
    
              2. Have serum EGF concentration >250 pg/ml determined from sample taken at screening.
    
              3. Have wild type EGF-R sequence.
    
              4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    
              5. Have adequate bone marrow, liver and renal function, as assessed by the Investigator.
                 A sample taken at Screening should confirm that:
    
                   -  White blood cell (WBC) count ≥ 3000 per µL
    
                   -  Platelet count ≥ 100,000 per µL
    
                   -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper
                      limit of normal (ULN) (or ≤ 5 x ULN when liver metastases are present)
    
                   -  Total bilirubin ≤ 1.5 x ULN
    
                   -  Serum creatinine ≤ 1.5 x ULN
    
              6. Have histologically and/or cytologically confirmed diagnosis of NSCLC, corresponding
                 to locally and regionally advanced inoperable disease (Stage IV [as defined by the
                 American Joint Committee on Cancer staging system- TNM 7th edition 2010]) excluding
                 brain metastases.
    
              7. Are eligible to receive first-line chemotherapy (without concurrent radiotherapy to
                 thorax measurable lesions or consolidation radiotherapy).
    
              8. Agree to use double-barrier contraception (males and females alike [if applicable]). A
                 negative pregnancy test must be documented at Screening for females of childbearing
                 potential.
    
                 Note: Females of childbearing potential are defined as those women with less than 2
                 years after last menstruation and not surgically sterile, while post-menopausal refers
                 to those women with at least 2 years from last menstruation.
    
              9. Have signed a voluntary written informed consent form (ICF). Patients should be
                 cooperative, willing and able to participate and adhere to the Protocol requirements,
                 including their availability for the follow-up.
    
            Exclusion Criteria:
    
              1. Patient has no measurable disease (as defined by RECIST Criteria, version 1.1).
    
              2. Patient has EGF-R mutation.
    
              3. Patient has EGF serum concentration below required threshold.
    
              4. Patient is a candidate for concurrent chemo-radiotherapy or post chemo thoracic
                 radiotherapy.
    
              5. Patient has a history of known or suspected central nervous system (CNS) metastases.
    
              6. Patient has a history of primary malignancy (except resected non-melanoma skin cancer
                 or curatively treated carcinoma in situ of the cervix), unless in complete remission
                 and off all chemotherapy and/or radiotherapy for that disease for a minimum of 5
                 years. Any palliative radiotherapy to alleviate pain in bone metastases is permitted.
    
              7. Patient is taking immunosuppressant drugs such as azathioprine, tacrolimus,
                 cyclosporine, etc. Use is not permitted within 1 month before Screening.
    
              8. Patient is taking any other immunotherapy.
    
              9. Patient has primary or secondary immunodeficiencies (e.g. documented Human
                 Immunodeficiency Virus [HIV]).
    
             10. Patient has autoimmune disease.
    
             11. Patient has undergone splenectomy.
    
             12. Patient is taking oral, intramuscular or intravenous corticosteroids. Use is not
                 permitted within 1 month before Screening. Inhaled corticosteroids to treat
                 respiratory insufficiency (e.g. chronic obstructive pulmonary disease [COPD]), or
                 topical steroids are permitted.
    
             13. Patient has neurotoxicity (Grade ≥2).
    
             14. Patient has diarrhoea (Grade ≥2).
    
             15. Patient has received other vaccines (with the exception of the influenza vaccine),
                 within 1 month before Screening.
    
             16. Patient has a history of any severe or life-threatening hypersensitivity reaction.
    
             17. Patient has an unstable systemic disease (including active infection, uncontrolled
                 hypertension, unstable angina, congestive heart failure, myocardial infarction within
                 the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal and
                 metabolic disease).
    
             18. Patient has recent history (within 6 months before Screening) of chronic alcohol or
                 drug abuse which may compromise the patient's safety or ability to participate in
                 study activities.
    
             19. Patient has a history of psychiatric disorder that prevents patients from providing
                 informed consent or following Protocol instructions.
    
             20. Patient is currently enrolled in an investigational device or drug trial, or <1 month
                 since completing an investigational device or drug trial.
    
             21. Female patients who are pregnant or lactating.
    
             22. Patient has any other factor that in the opinion of the Investigator (or designee)
                 would make the patient unsafe or unsuitable for the study.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Overall Survival (OS)
    Time Frame:Each patient will be followed till death occurs within study time frame of 3 years
    Safety Issue:
    Description:To assess overall survival (OS) of an EGF cancer vaccine in inoperable, stage IV biomarker positive, wild type EGF-R, NSCLC patients compared to the control group receiving best treatment and supportive care. OS is defined as the time from randomisation to death due to any cause.

    Secondary Outcome Measures

    Measure:Safety of EGF Cancer Vaccine as assessed by Adverse Events (AEs)
    Time Frame:Each patient will be followed till death occurs within study time frame of 3 years
    Safety Issue:
    Description:To assess the frequency and number of patients develop AEs, related AEs, serious AEs (SAEs) and AEs leading to withdrawal or death
    Measure:Progression-Free Survival (PFS)
    Time Frame:Each patient will be followed till objective tumour progression or death (whichever occurs first) within time frame of study of 3 years
    Safety Issue:
    Description:Progression parameters include radiological or clinical progression, withdrawal due to progression, and death due to any cause.
    Measure:Survival Rate
    Time Frame:Each patient will be followed at 12 and 24 months after randomization
    Safety Issue:
    Description:To assess the percentage of patients that are alive at 12 months and 24 months in EGF cancer vaccine study group compared to control group.
    Measure:Time to Progression (TTP)
    Time Frame:Each patient will be followed till observed tumour progression within study time frame of 3 years
    Safety Issue:
    Description:To assess Time to Progression (TTP) from the time of randomisation to first documented disease progression of EGF cancer vaccine study group patients compared to control group.
    Measure:Response Rate (RECIST criteria)
    Time Frame:Each patients will be followed till death occurs within study time frame of 3 years
    Safety Issue:
    Description:To assess the percentage of patients with a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria Version 1.1.
    Measure:Safety of EGF Cancer Vaccine by Laboratory Assessment
    Time Frame:Each patients will be followed till death occurs within study time frame of 3 years
    Safety Issue:
    Description:To assess haematology, biochemistry and urinalysis parameters
    Measure:Safety of EGF Cancer Vaccine assessed by Vital Signs
    Time Frame:Each patients will be followed till death occurs within study time frame of 3 years
    Safety Issue:
    Description:To assess systolic and diastolic blood pressure, body temperature and pulse rate
    Measure:Safety of EGF Cancer Vaccine as assessed by Physical Examination
    Time Frame:Each patient will be followed till death occurs within study time frame of 3 years
    Safety Issue:
    Description:To assess eyes, neurological and cardiovascular systems, lungs, abdomen, and any other areas with signs and symptoms of disease, and of the head, neck, ears, nose, mouth, throat, thyroid, lymph nodes and extremities
    Measure:Quality of Life (QoL)
    Time Frame:Each patient will be followed till death occurs within study time frame of 3 years
    Safety Issue:
    Description:To assess the general physical health of patients with a 36-item, short-form health survey until disease progression

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Bioven Europe

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