Patient with metastatic Non Small Cell Lung Cancer (NSCLC) stage IV. MedDRA version: 15.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient with Non Small Cell Lung Cancer (NSCLC) who has been treated with palliative radiotherapy and/or at least three courses of chemotherapy, and has achieved stable disease (SD), partial response (PR) or complete response (CR) confirmed by CT scan at least 4 weeks after end of treatment. Previous curative radiotherapy is allowed as long as the patient has relapsed and received palliative chemotherapy. • No evidence of disease progression at the time of inclusion • Must be ambulatory with an ECOG performance status of 0, 1 or 2 • Must be at least 18 years of age. • No sign of brain metastases (excluded by MRI of brain ). •Must have lab values as follows: - White Blood Cells >= 1.5 x 109/L - Platelets >= 100 x 109/L - Hemoglobin >= 9g/dL (>=5.6 mmol/L) - Creatinine = 2.5 g/L •Signed 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: • History of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB or effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured. • Treatment with any other investigational medicinal product (IMP) within 4 weeks prior to first administration of study drug. • Adverse reactions to vaccines such as anaphylaxis or other serious reactions. • History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, sclerodermia, polymyositis-dermatomyositis, juvenile onset insulin-dependent diabetes, or a vasculitic syndrome. • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia. • Active infection requiring antibiotic therapy. • Pregnancy or lactation. • Woman of childbearing potential not using any reliable and adequate contraceptive methods defined as use of oral, implanted, injectable, and mechanical or barrier products for the prevention of pregnancy. • Known sensitivity to any of the components of the vaccine • Known hypersensitivity to Leukine®, yeast derived products or any component of the product • Patients who test positive for hepatitis B, C or HIV. • Any other anti-tumor treatment within 4 weeks of study entry (including chemotherapy, immunotherapy, endocrine therapy, cytokines, interferons, protease inhibitors and gene therapy). • Use of not permitted concomitant medication: - chronic corticosteroids except for asthma inhalers / topical use - any alternative and complementary drugs. • Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunological response to UV1 vaccine and assessment of safety and tolerability of UV1. ;Secondary Objective: Selection of biological dose of peptides for further clinical trials and assessment of anti-tumor activity.;Primary end point(s): - Frequency and severity of adverse events and serious adverse events. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) will be used. Changes in laboratory values, vital signs and ECOG performance status will also be assessed. - Number of T-cell responses including time to T-cell responses (up to 6 months), level of response and duration of response. ;Timepoint(s) of evaluation of this end point: - Safety profile will be evaluated at each visit. Patient will come during week 1, 2, 3, 4, 6, 8, 10, every 4 weeks until week 26 and every 3 months during any additionnal vaccination period. FU will be done at 3 months post vaccination. -T cell response will be measured at baseline, during vaccination (every 4 weeks starting at week 2), end of treatment and at the end of the 3 months follow up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Tumor response and progression free survival (PFS). RECIST version 1.1 will be used. - Safety profile and immunological responses of each dose level. ;Timepoint(s) of evaluation of this end point: -Tumor response and PFS will be evaluated by regular physical examination and CT-scan every 3 months during vaccination period and at the 3 month FU visit. -Safety profile and immunological responses of each dose level will be evaluated when patients have completed 6 months of vaccinations and have been followed up for at least a further 3 months. Additionnal evaluation will be done when patients have completed the remaining vaccination period and have been followed up for a further 3 months. | — |
Countries
Norway
Contacts
Public ContactPaal Brunsvig
Oslo University Hospital
Outcome results
None listed