A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer.
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
The following 2-step design will be used:
1. Conventional dose escalation with at least 3 patients per dose level (3 selected dose
2. Expansion of each dose level to a total of 7 patients for assessment of immune response
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 administered locally 10-15 minutes
before each UV1 vaccination.
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
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of safety and tolerability of UV1.
Frequency and severity of adverse events and serious adverse events. Biochemistry and hematology results, vital signs and ECOG performance status will be assessed.
up to 2 years and 3 months.
Paal F. Brunsvig, MD PhD
Oslo University Hospital
Norway: Norwegian Medicines Agency