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

NCT01789099 | Completed Phase 1 DMC

• 1 other identifier: 2012-001852-20
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-small Cell Lung Cancer

Keywords

Lung cancer; Peptide vaccine

Outcome Measures

Primary Outcomes (2)

• 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.

• Immunological response

  Number of T-cell responses including time to T-cell responses (up to 6 months), level of response and duration of response.

  Up to 2 years and 3 months.

Secondary Outcomes (2)

• Assessment of anti tumor activity

  Up to 2 years and 3 months

• Selection of biological dose of peptides for further clinical trials.

  Up to 2 years and 3 months

Other Outcomes (2)

• Potential correlation between human cytomegalovirus status and immune response

  Up to 2 years and 3 months

• Further characterization of the immune reaction triggered by the treatment.

  Up to 2 years and 3 months

Study Arms (1)

UV1 synthetic peptide vaccine and GM-CSF

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.

Biological: UV1 synthetic peptide vaccine and GM-CSF

Interventions

UV1 synthetic peptide vaccine and GM-CSF BIOLOGICAL

Also known as: UV1, Leukine

UV1 synthetic peptide vaccine and GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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:
• Inactive metastases (without evidence of progression which is documented by CT or MRI within 4 weeks prior to the planned study treatment date), and
• If prednisolone or equivalent treatment is required; no more \</=10mg/day is permitted.
• 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 product
• 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).

Sponsors & Collaborators

• Ultimovacs ASA: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

• Brunsvig PF, Guren TK, Nyakas M, Steinfeldt-Reisse CH, Rasch W, Kyte JA, Juul HV, Aamdal S, Gaudernack G, Inderberg EM. Long-Term Outcomes of a Phase I Study With UV1, a Second Generation Telomerase Based Vaccine, in Patients With Advanced Non-Small Cell Lung Cancer. Front Immunol. 2020 Nov 26;11:572172. doi: 10.3389/fimmu.2020.572172. eCollection 2020.

  PMID: 33324397 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Paal F. Brunsvig, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 11, 2013
• Study Start: April 8, 2013
• Primary Completion: February 29, 2016
• Study Completion: June 12, 2020
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

NO (1)