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

Development of AImmune Technology as a Bioinformatic Component of Diagnostic Tests Used in Cancer Immunotherapy

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • Recruiting
    • University Clinical Centre in Gdansk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving routine treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NSCLC; This cohort will consist of 30 patients with non-small cell lung cancer (NSCLC).	Biological: Collection of biopsy (FFPE), blood (PBMC) and stool; Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).; Other Names: Atezolizumab; Nivolumab; Ipilimumab

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ardigen
• Collaborators: Małopolskie Centre of Entrepreneurship
• Investigators: Principal Investigator: Piotr Stepniak, Ardigen

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2019
• Primary Completion (ANTICIPATED): October 15, 2020
• Study Completion (ANTICIPATED): November 30, 2020

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (ACTUAL): October 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Nivolumab; Immunotherapy; Non Small Cell Lung Cancer; Ipilimumab; Atezolizumab; FFPE; Stool; Immuno-Oncology; PBMC; Neoepitopes; Neoantigens; Neoantigen cancer vaccine; Personalized neoantigen cancer vaccine; Next generation sequencing (NGS)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Ipilimumab; Atezolizumab
• Other Study ID Numbers: A.I.mmune; RPMP.01.02.01-12-0301/17 (OTHER_GRANT: Małopolskie Centre of Entrepreneurship)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No