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A Phase III, Open-label, Multicentre, Randomised Trial to Establish Safety and 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

PHRR160826-001350

BV-NSCLC-002

2014-CT0237

A Phase III, open-label, multicentre, randomised trial to establish safety and 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

A Phase III, open-label, multicentre, randomised trial to establish safety and 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. This is a Phase III, open-label, multicentre, randomised trial.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2016-02-11 48 2020-02-11 1900-07-31

Terminated

Sponsor Decision

Institution Classification Region LTO #
Bioven (Europe) Ltd. Private Business United Kingdom not applicable
Institution Classification Region LTO #
Novotech (Australia) Pty. Ltd. - Philippine Branch Private Business NCR CDRR-NCR-CRO-11
Institution Region
Bioven (Europe) Ltd. United Kingdom
Name E-Mail Institution and Institution Address
Jennifer Olive Arellano jenny.arellano@novotech-cro.com Marco Polo Hotel 1912 Novotech Australia PTY LTD (PH Branch) Ortigas Center Pasig City
Name E-Mail Institution and Institution Address
Jennifer Olive Arellano jenny.arellano@novotech-cro.com Marco Polo Hotel 1912 Novotech Australia PTY LTD (PH Branch) Ortigas Center Pasig CityRoad (formerly Emerald Avenue), Ortigas Center, Pasig City, 1605, Philippines
Name Expertise Affiliation
Arnold Germar, MD Medical Oncology Veterans Memorial Medical Center
Beatrice J. Tiangco, MD Medical Oncology The Medical City
Dennis Ramon Tudtud, MD Medical Oncology Perpetual Succour Hospital
Felycette Gay Martinez-Lapus, MD Medical Oncology Davao Doctors Hospital
Jennifer Sandoval-Tan, MD Medical Oncology University of the Philippines - Philippine General Hospital
Jerry Tan Chun Bing, MD Medical Oncology Cebu Doctors' University Hospital
Maria Belen E. Tamayo, MD Medical Oncology Makati Medical Center
Sullian S. Naval, MD Medical Oncology Lung Center of the Philippines
Project Location Institutional Ethics Review Board
Veterans Memorial Medical Center Veterans Memorial Medical Center Ethics Review Committee
The Medical City The Medical City - Institutional Review Board
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
Davao Doctors Hospital Davao Doctors Hospital Ethics Review Committee
University of the Philippines - Philippine General Hospital N/A
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee
Makati Medical Center Makati Medical Center Institutional Review Board
Lung Center of the Philippines Lung Center of the Philippines Ethics Review Committee

EGF cancer vaccine in inoperable, stage IV biomarker positive, wild type EGF-R,
NSCLC

To assess overall survival (OS) of an EGF cancer vaccine in inoperable, stage IV biomarker positive, wild type EGF-R, NSCLC patients when compared to the control group receiving best treatment and supportive care.

 To assess progression-free survival (PFS), survival rate, time to progression (TTP), response rate (RECIST criteria) and quality of life (QoL).
 To establish the safety of an EGF cancer vaccine in inoperable, stage IV NSCLC patients.

Recruiting

  • Australia
  • Czech Republic
  • Germany
  • Hungary
  • India
  • Malaysia
  • Philippines
  • Poland
  • Romania
  • Spain
  • Thailand
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

Clinical Trial

BV-NSCLC-002

2014-CT0237

2014-11-27

0000-00-00

54

Unspecified

Unspecified

11 Feb 2016

Patients are eligible to be included in the study if they:
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.
 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 platinum-containing chemotherapy (carboplatin or cisplatin with docetaxel, gemcitabine, paclitaxel, pemetrexed or vinorelbine, without concurrent radiotherapy to thorax measurable lesions or consolidation radiotherapy).
8. A female subject is eligible to participate if she is of: Non-childbearing potential women refers to those women who are postmenopausal (with at least 2 years from last menstruation) or permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the appropriate contraception methods in Section 8.1. This criterion must be followed during their participation in the study, if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. A negative pregnancy test (based on the β-subunit of HCG) must be documented at Screening for females of childbearing potential and use one of appropriate contraception methods in Section 8.1. This criterion must be followed during their participation in the study. Note: Females of childbearing potential are defined as those women with less than 2 years after last menstruation and not surgically sterile.
9. Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed during their participation in the study.
10. 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.

Patients will be ineligible if one or more of the following statements are applicable:  
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. for Human Immunodeficiency Virus [HIV] confirmed positive test at screening).
10. Acute or chronic hepatitis B or hepatitis C infection. (confirmed positive test at screening for HBV and/or HCV)
11. Patient has autoimmune disease.
12. Patient has undergone splenectomy.
13. 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.
14. Patient has neurotoxicity (Grade ≥2).
15. Patient has diarrhoea (Grade ≥2).
16. Patient has received other vaccines (with the exception of the influenza vaccine), within 1 month before Screening.
17. Patient has a history of any severe or life-threatening hypersensitivity reaction to the investigational drugs/components being administered in the study.
18. 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).
19. 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.
20. Patient has a history of psychiatric disorder that prevents patients from providing informed consent or following Protocol instructions. 21. Patient is currently enrolled in an investigational device or drug trial, or drug trial.
22. Female patients who are pregnant or lactating.
23. Patient has any other factor that in the opinion of the Investigator (or designee) would make the patient unsafe or unsuitable for the study.

Interventional

Human recombinant EGF (hurEGF)

The active component of the vaccine is human recombinant EGF (hurEGF). The P64K carrier protein from N.meningitidis plays a role in overcoming immunological tolerance to self proteins, in this particular case, the human EGF. Both biological compounds are recombinant compounds produced in Yeast and E.coli cells, respectively. Prior to vaccination, the active chemical conjugate (hu-rEGF-rP64K) will be mixed with the adjuvant (Montanide ISA 51 VG [Seppic, France]). Both components (conjugate and adjuvant) are in one dose presentations.

None

Randomized

Open Label

Unspecified

Parallel

To assess overall survival (OS) of an EGF cancer vaccine in inoperable, stage IV biomarker positive, wild type EGF-R, NSCLC patients when compared to the control group receiving best treatment and supportive care.

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
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