A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III)

• Register: EUCTR
• Last refreshed on: 18 April 2017
• Main ID: EUCTR2011-005968-24-DE
• Date of registration: 15/02/2012
• Prospective Registration: Yes
• Primary sponsor: Vaxon Biotech
• Public title: A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III)
• Scientific title: A multicenter, randomized, double-blind, placebo-controlled Phase IIb Efficacy Study of Vx-001, a peptide-based cancer vaccine aimed to maintain disease control after first line treatment in HLA-A*0201 positive patients with TERT positive NSCLC (stage IV or recurrent stage I-III) - VaxLung
• Date of first enrolment: 23/01/2013
• Target sample size: 220
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005968-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: multi-centre If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, Germany, Greece, Italy, Spain

Contacts

• Name: Kostas Kosmatopoulos
• Affiliation: Vaxon Biotech

• Name: Kostas Kosmatopoulos
• Affiliation: Vaxon Biotech

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female >/=18 years of age;
2. Documented stage IV NSCLC as defined by IASLC Lung Cancer Staging Project (7th edition) or recurrent stage I-III disease at least 6 months after resection or after the end of adjuvant chemotherapy or after standard locoregional treatment as defined by the American College of Chest Physicians;
3. Patients treated with 4 cycles platinum based 1st line chemotherapy as defined by the American College of Chest Physicians (i.e. radiotherapy are not allowed except palliative radiotherapy of bone metastasis);
4. Documented HLA-A*0201 positivity, as determined by a local laboratory;
5. TERT-positive NSCLC, as assessed by a central laboratory; for this, availability of adequate tissue biopsy from the primary tumor, lymph nodes or distant metastases is a prerequisite;
6. CR, PR, or SD according to RECIST criteria after the completion of platinum-based first-line chemotherapy;
7. First vaccination have to be administered no more than 4 weeks after the last administration of platinum-based 1st line chemotherapy;
8. ECOG performance status 0, 1;
9. Patients must have adequate renal and hepatic function as assessed by standard laboratory criteria;
10. Patients must have adequate haematological function:
• Platelet count >/= 100 x 109/L;
• WBC count >/= 2.5 x 109/L;
• Hemoglobin >/= 90g /L;
11. Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential must have a negative urine pregnancy test at baseline and agree to practice adequate contraception for 30 days prior to administration of investigational product, throughout the study treatment period and 30 days after completion of injections;
12. In the investigator’s opinion, the patient is capable and willing to comply with the requirements of the study;
13. Willing and able to sign a written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion criteria:
1. Mixed small cell and NSCLC histologies;
2. Patients with stage IV or recurrent NSCLC who have been previously treated with therapy other than platinum-based first-line chemotherapy;
3. Prior treatment with cancer vaccines;
4. Prior treatment with immunotherapy (eg interferons, interleukins, TNF, or biological response modifiers, such as GM-CSF etc) within four weeks prior to randomization;
5. Prior treatment with hormone (including corticosteroids) within 2 weeks prior to randomization;
6. Prior treatment with any investigational drugs, within 4 weeks prior to randomization;
7. Patients with brain metastases;
8. Past and current history of neoplasm other than NSCLC, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated with no evidence of disease for at least five years;
9. Autoimmune or immunodeficiency disease that in the opinion of the investigator may compromise the safety of the patient in the study;
10. Any pre-existing medical condition requiring concomitant systemic corticosteroid or immunosuppressive therapy. The use of inhaled corticosteroids for COPD or topical steroids is allowed;
11. Known hepatitis B and/or C infection, testing not required;
12. Known HIV-positivity, testing not required;
13. Clinically significant hepatic dysfunction (ALT>2.5 times normal upper limits [ULN], AST>2.5 times ULN, bilirubin>1.5 times ULN);
14. Clinically significant renal dysfunction (serum creatinine>1.5 time ULN);
15. Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease with unstable angina or myocardial infarction within 6 months of randomization) or uncontrolled ventricular arrhythmias at the time of enrolment in the study (atrial fibrillation or flutter is acceptable);
16. Splenectomy or splenic irradiation;
17. Any infectious condition that, in the opinion of the investigator, could compromise the patient’s ability to develop an immune response;
18. Pregnant or lactating females (female patients of child-bearing potential will undertake pregnancy testing at screening and during study completion/withdrawal visits);
19. Alcohol or drug use or dependence;
20. Requirement of concurrent treatment with prohibited medication (investigational product, other anti-cancer treatments including chemotherapy, non-palliative radiotherapy, biological agents and immunomodulating agents, systemic immunosuppressive agents, including systemic corticosteroids);
21. The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Non-small cell lung cancer
MedDRA version: 17.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: CRYPTIC PEPTIDE
Product Code: ARG-Vx001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: Vx-001
Other descriptive name: OLIGOPEPTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: OPTIMIZED PEPTIDE
Product Code: TYR-Vx001
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
Current Sponsor code: Vx-001
Other descriptive name: OLIGOPEPTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Trade Name: Montanide ISA 51 VG
Product Name: Montanide
Product Code: ISA 51 VG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: Vx-001
Other descriptive name: MINERAL OIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: The secondary objectives are:
• Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients,
• Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients

Main Objective: The primary objective is to compare survival rate at 12 months in Vx-001 treated vs placebo treated patients.

Primary end point(s): The primary objective is to compare survival rate in Vx-001 treated vs placebo treated patients.

Timepoint(s) of evaluation of this end point: 12 months from start of therapy with IMP

Secondary Outcome(s)

Secondary end point(s): • Time-to-event comparison of overall survival (OS) in Vx-001 treated vs placebo treated patients,
• Comparison of Time to Treatment Failure in Vx-001 treated vs placebo treated patients

Timepoint(s) of evaluation of this end point: •Death of patient
•Progression of disease - onset of 2nd line therapy

Secondary ID(s)

Vx-001-201

Source(s) of Monetary Support

Vaxon Biotech