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

NCT04145232 | Unknown

• 2 other identifiers: A.I.mmuneRPMP.01.02.01-12-0301/17
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

NSCLC

This cohort will consist of 30 patients with non-small cell lung cancer (NSCLC).

Biological: Collection of biopsy (FFPE), blood (PBMC) and stool

Interventions

Collection of biopsy (FFPE), blood (PBMC) and stool BIOLOGICAL

Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).

Also known as: Nivolumab, Ipilimumab, Atezolizumab

NSCLC

Eligibility Criteria

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

Study Population

Patients receiving routine treatment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ardigen: lead
• Małopolskie Centre of Entrepreneurship: collaborator

Study Sites (1)

University Clinical Centre in Gdansk

Gdansk, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

biopsy (FFPE), peripheral blood samples (PBMC) and stool

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms

Interventions

Blood Specimen Collection; Nivolumab; Ipilimumab; atezolizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Piotr Stepniak

  Ardigen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martyna Balawejder

CONTACT

+48 883 319 890; martyna.balawejder@ardigen.com

Bozena Augustyn

CONTACT

+48 12 340 94 94; bozena.augustyn@ardigen.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 30, 2019
• Study Start: June 13, 2019
• Primary Completion: October 15, 2020
• Study Completion: November 30, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

PL (1)