NCT01789099

A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ultimovacs ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. Follow-up is ongoing

Detailed 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

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	UV1 synthetic peptide vaccine and GM-CSF

Timeline

• Start date: 2013-04-08
• Primary completion: 2016-02-29
• Completion: 2020-06-12
• First posted: 2013-02-11
• Last updated: 2024-12-16

Locations

1 site across 1 country: Norway