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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

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

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.

- 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 ≥ 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

- 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 hypersensitivity to any of the components of the vaccine

- Known hypersensitivity to Leukine®, yeast derived products or any component of the

- 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 agent with a known effect on the immune system, unless it is being given at dose
levels that are not immunosuppressive, e.g. prednisone at 10mg/day or less.

- any alternative and complementary drugs that may affect the immune system or be
potentially harmful to patients participating in phase I studies.

- Any reason why, in the opinion of the investigator, the patient should not

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of safety and tolerability of UV1.

Outcome Description:

Frequency and severity of adverse events and serious adverse events. Biochemistry and hematology results, vital signs and ECOG performance status will be assessed.

Outcome Time Frame:

up to 2 years and 3 months.

Safety Issue:


Principal Investigator

Paal F. Brunsvig, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital


Norway: Norwegian Medicines Agency

Study ID:




Start Date:

February 2013

Completion Date:

February 2017

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer
  • Peptide vaccine
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms