AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.

• Conditions: Non Small Cell Lung Cancer; Neoantigens; Neoepitopes; Immunotherapy; Next Generation Sequencing (NGS); Personalized Neoantigen Cancer Vaccine
• Interventions: Biological: Collection of biopsy (FFPE), blood (PBMC) and stool

• Registration Number: NCT04145232
• Lead Sponsor: Ardigen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-13
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-10
• Primary Completion: 2020-10-15
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NSCLC	Collection of biopsy (FFPE), blood (PBMC) and stool	This cohort will consist of 30 patients with non-small cell lung cancer (NSCLC).

Primary Outcome Measures

Name	Time	Method
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)	Up to 6 months	Standard follow-up care after cancer treatment.

Trial Locations

Locations (1)

University Clinical Centre in Gdansk; 🇵🇱 Gdańsk, Poland