Breathomics as Predictive Biomarker for Checkpoint Inhibitor Response

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Brief Title

Breathomics as Predictive Biomarker for Checkpoint Inhibitor Response

Official Title

Breathomics as a Non-invasive, Inexpensive, Point-of-care Predictive Test for Immune Checkpoint Inhibitor Efficacy

Brief Summary

      Immunotherapy with agents stimulating the immune system to act against cancer are now a new
      standard of care in various cancers as lung cancer and melanoma, but also bladder cancer,
      kidney cancer and head & neck cancer. However, even though a subset of patients derives
      long-term benefit from these agents, depending of cancer type still at least half of patients
      do not respond to these new drugs. Our understanding of possible factors predicting whether a
      patient might actually benefit from immunotherapy is poor. Volatile organic compounds (VOCs)
      are gases exhaled with a person's breath, which are released into the lung from blood and
      bacteria and therefore can give information about infections as well as inflammation and
      possibly cancer cells in a person's body. Breath analysis of these VOCs with special devices
      called electronic noses (eNose) generate a specific electric signals patterns called
      breathprints. There is early evidence that specific breathprints can actually help to select
      patients who will be likely to benefit from immunotherapy.

      This study is being undertaken in an effort to evaluate breathprint analysis as a potential
      predicting factor for benefit from immunotherapy, so that treatment selection can further be
      improved.

      This study is designed to help us identify the role of breathprint analysis to better select
      patients for immunotherapy.
    

Detailed Description

      Immune checkpoint blockade with anti-PD-1 and anti-PD-L1 antibodies has become a new standard
      of care in several cancer types as NSCLC and melanoma. However, in biomarker-unselected
      patient populations, overall response rate (ORR) depending on type of cancer and whether
      single or combination treatment is chosen remains still only 20%-60%. Though overall well
      tolerated approximately 5-10% of patients treated with PD1/PD-L1 targeting agents will
      experience grade 3 or 4 toxicities, including potentially life-threatening auto-immune
      toxicities such as colitis, hepatitis, and pneumonitis. Therefore, due to high costs of
      treatment and its possible complications, improved selection of patients is a crucial goal
      and an easily available non-invasive, point-of-care test for better patient selection is very
      much needed.

      A promising approach in this regard is the analysis of volatile organic compounds (VOCs) in
      breath. Breath analysis for the detection of VOCs is increasingly investigated for its
      utility in diagnosis and management of cancer. Electronic noses (eNoses) are promising as
      cheap and clinically-practical devices that are designed to detect patterns of VOCs. Recently
      published prospective observational data showed very promising discriminant function for
      breathprint analysis for non-response to immunotherapy in NSCLC patients.

      The principle goal of this study is to validate a prior study that found that
      breathomics-based classifiers predicted 12-week early progression vs non-progression in
      advanced NSCLC patients treated with nivolumab or pembrolizumab. Secondarily, we will expand
      assessment of breathomic-based classifiers to include other cohorts of advanced tumors
      treated with ICI, and also consider using response instead of non-progression as an endpoint.
      Exploratory goals include refinement of the breathomics classifier using alternative
      machine-learning techniques, and correlate with other biomarkers of immunotherapy outcomes.
    


Study Type

Observational


Primary Outcome

12 week Progression Rate in validation cohort

Secondary Outcome

 Overall Survival (OS) in validation cohort

Condition

NSCLC

Intervention

Breathprint analysis and patient-reported outcomes

Study Arms / Comparison Groups

 Validation cohort: NSCLC
Description:  Patients with advanced/metastatic NSCLC planned for IO-treatment in one of the following categories
Pembrolizumab monotherapy first-line
Pembrolizumab or nivolumab monotherapy in second or later line

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

425

Start Date

February 24, 2020

Completion Date

May 2024

Primary Completion Date

May 2024

Eligibility Criteria

        INCLUSION CRITERIA

          -  Patients 18 years of age or older

          -  Histologically confirmed advanced/metastatic non-small cell lung cancer, melanoma or
             solid tumor such as urothelial, kidney or head and neck cancer and planned treatment
             with

               -  NSCLC validation cohort: Pembrolizumab or Nivolumab

               -  NSCLC Cohort 1: Pembrolizumab-chemotherapy combination therapy 1L

               -  Melanoma Cohort 2: Nivolumab/ipilimumab combination treatment 1L, Pembrolizumab
                  or nivolumab monotherapy treatment 1L , Ipilimumab

               -  Solid tumors Cohort 3: Any ICI-treatment, any line

               -  NSCLC Cohort 4: Chemotherapy-only (either platinum-based combination treatment or
                  docetaxel monotherapy)

          -  At least one measurable lesion as defined by RECIST 1.1. A lesion at a previously
             irradiated site may only be counted as a target lesion if there is clear sign of
             progression since the irradiation.

          -  Able to provide informed consent.

        EXCLUSION CRITERIA

          -  Patients who are unable to perform the breathing manoeuvres needed for eNose-analysis
             of exhaled air.

          -  Patients who are unable to independently consent to participation in the trial.

          -  Patients with severe, acute, or chronic medical conditions (including uncontrolled
             diabetes mellitus) or psychiatric conditions or laboratory abnormalities that in the
             opinion of the Investigator or their physician may cause undue harm or inconvenience
             to the patient, or that may interfere with the interpretation of study results.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Geoffrey Liu, MD MSc, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04146064

Organization ID

IO-Breathomics

Secondary IDs

19-5936

Responsible Party

Sponsor

Study Sponsor

University Health Network, Toronto

Collaborators

 University of Amsterdam

Study Sponsor

Geoffrey Liu, MD MSc, Principal Investigator, UHN


Verification Date

April 2021