A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (UV1-hTERT2012L)
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|ClinicalTrials.gov Identifier: NCT01789099|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2013
Last Update Posted : April 4, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Biological: UV1 synthetic peptide vaccine and GM-CSF||Phase 1 Phase 2|
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:
- Conventional dose escalation with at least 3 patients per dose level (3 selected dose levels).
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer.|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Experimental: UV1 synthetic peptide vaccine and GM-CSF
GM-CSF (Leukine) followed by UV1 peptide vaccine with escalating concentrations (100, 300 and 700 microgram) will be injected intradermally in the lower abdomen.
Biological: UV1 synthetic peptide vaccine and GM-CSF
- Assessment of safety and tolerability of UV1. [ Time Frame: up to 2 years and 3 months. ]Frequency and severity of adverse events and serious adverse events. Biochemistry and hematology results, vital signs and ECOG performance status will be assessed.
- Immunological response [ Time Frame: Up to 2 years and 3 months. ]Number of T-cell responses including time to T-cell responses (up to 6 months), level of response and duration of response.
- Assessment of anti tumor activity [ Time Frame: Up to 2 years and 3 months ]Tumor response and progression free survival (PFS)
- Selection of biological dose of peptides for further clinical trials. [ Time Frame: Up to 2 years and 3 months ]Safety profile and immunological responses of each dose level.
- Potential correlation between human cytomegalovirus status and immune response [ Time Frame: Up to 2 years and 3 months ]Determination of human cytomegalovirus (CMV) status
- Further characterization of the immune reaction triggered by the treatment. [ Time Frame: Up to 2 years and 3 months ]Extended immunological analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789099
|Oslo University Hospital|
|Oslo, Norway, 0424|
|Principal Investigator:||Paal F. Brunsvig, MD PhD||Oslo University Hospital|