Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment uv1 synthetic peptide vaccine and gm-csf
Phase phase 1/phase 2
Sponsor Ultimovacs AS
Collaborator Oslo University Hospital
Start date February 2013
End date February 2020
Trial size 18 participants
Trial identifier NCT01789099, 2012-001852-20

Summary

In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials. Study recruitment completed at 6 patients in every dose level.

The main study treatment phase of this study is completed and will be reported separately.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
GM-CSF (Leukine) followed by UV1 peptide vaccine with escalating concentrations (100, 300 and 700 microgram) will be injected intradermally in the lower abdomen.
uv1 synthetic peptide vaccine and gm-csf UV1

Primary Outcomes

Measure
Assessment of safety and tolerability of UV1.
time frame: up to 2 years and 3 months.
Immunological response
time frame: Up to 2 years and 3 months.

Secondary Outcomes

Measure
Assessment of anti tumor activity
time frame: Up to 2 years and 3 months
Selection of biological dose of peptides for further clinical trials.
time frame: Up to 2 years and 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 - Must be at least 18 years of age. - 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 ≥ 140 µmol/L - Bilirubin < 20% above the upper limit of normal - ASAT and ALAT ≤ 2.5 the upper limit of normal - Albumin ≥ 2.5 g/L - Signed informed consent 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. - Known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may however participate provided they meet the following criteria: 1. Inactive metastases (without evidence of progression which is documented by CT or MRI within 4 weeks prior to the planned study treatment date), and 2. If prednisolone or equivalent treatment is required; no more

Additional Information

Official title A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer.
Principal investigator Paal F. Brunsvig, MD PhD
Description This is an open label dose-escalating phase I/IIa study of UV1 peptide vaccination in patients with NSCLC after completion of radiation therapy and/or chemotherapy. Patients will be enrolled in this study if they have achieved complete response (CR), partial response (PR) or stable disease (SD) at least 4 weeks after completion of standard first line therapy. The following 2-step design will be used: 1. Conventional dose escalation with at least 3 patients per dose level (3 selected dose levels). 2. Expansion of each dose level to a total of 6 patients for assessment of immune response levels. 13 UV1 vaccinations will be given during the first 6 months (week 26) of treatment, unless clinical deterioration or unacceptable toxicity is encountered. Granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine ®) will be used as adjuvant for 11 of the 13 doses of UV1. After completion of the main study treatment period at week 26, if the patient agrees, additional vaccinations may be considered for the following patients: - Immune responders within first 6 months - Immune non-responders providing they have at least SD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Ultimovacs AS.