Clinical trial NCT04145232: AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.
Official title: Development of AImmune Technology as a Bioinformatic Component of Diagnostic Tests Used in Cancer Immunotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Neoepitopes
Neoantigens
Immunotherapy
Next Generation Sequencing (NGS)
Personalized Neoantigen Cancer Vaccine
Keywords: Cancer
Non Small Cell Lung Cancer
Neoepitopes
Neoantigens
Immunotherapy
Nivolumab
Ipilimumab
Atezolizumab
Neoantigen cancer vaccine
Personalized neoantigen cancer vaccine
FFPE
PBMC
Stool
Immuno-Oncology
Next generation sequencing (NGS)
Lead sponsor: Ardigen
Sponsor class: INDUSTRY
Collaborators: name: Małopolskie Centre of Entrepreneurship
First posted: 2019-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving routine treatment.

Brief summary: The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to identify cancer neoantigens, which are likely to elicit an immune response.

A key challenge to be solved using the technology is to predict for each patient which neoepitopes are not only likely to bind to HLA or be presented on the tumor cell surface, but also will be recognized by the T-cell receptor and create the immunogenic response. The presence of such epitopes is required for immunotherapy by immune checkpoint inhibition to have an effect on the disease. Knowledge of those epitopes enables therapeutic strategies to boost the immune response by designing personalized cancer vaccines and adoptive cell therapies.

The samples and data collected in this clinical study will be used for clinical validation of A.I.mmune technology. For all patients treated with immunotherapy (using anti-PD1 / anti-PDL1 and / or anti-CTLA-4 antibodies) peripheral blood samples (PBMC) and biopsy (FFPE) collection will be performed before treatment. Samples will be sequenced by next-generation sequencing platform. In parallel, the investigators will also collect samples of stool (one sample before the start of immunotherapy) and follow-up information of responses to treatment.


Eligibility criteria: Inclusion Criteria:

* Men or women ≥18 years of age.
* Patients with non-small cell lung cancer.
* Patients with informed consent to participate in the study.
* Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
* The applied immunotherapy should be the first or second line of treatment.

Exclusion Criteria:

* Patients who are unable to understand, read and / or sign informed consent.
* Patients who can not collect stools.
* Patients with fecal transplant.
* The applied immunotherapy is not the first or second line of treatment.

Primary outcomes:
measure: Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: University Clinical Centre in Gdansk
Study officials:
affiliation: Ardigen
name: Piotr Stepniak
role: PRINCIPAL_INVESTIGATOR
References: