Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics (PROPHETIC)

PROPHETIC Extended - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Extended Study.

The goal of this exploratory study is understand the mechanisms of response to immunotherapy in Non-Small Cell Lung Cancer patients.

The investigators are going to search for correlation between specific biological features and response to immunotherapy, and to use those associations for developing an algorithm enabling to identify patients that could benefit from the immune check inhibitor based anti cancer treatment.

Patients will provide biological samples before and during their treatment, and clinical data will be collected.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Non Small Cell Lung Cancer
• Intervention / Treatment: Other: blood, stool and tissue samples collection

Detailed Description

The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their:

• Response to treatment
• Clinical benefit parameters such as PFS and OS.
• Adverse events to immune check inhibitor therapy
• Biological mechanisms involved in response or resistance to immune check inhibitor therapy.

Patients will provide plasma, PBMCs, stool and tissue samples (where applicable) before and during treatment.

Clinical data, including disease history, given treatment, response evaluation and adverse events to the treatment will be recorded.

Samples will be analysed as follows -

• Proteomic features (Plasma proteomics)
• Epigenetic patterns (cell free DNA)
• ctDNA mutation analysis
• PBMC subpopulations
• Microbiome profiling (Stool)

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Galit Yahalom, PhD; Phone Number: 97248537557; Email: galit@oncohost.com
• Study Contact Backup: Name: Shani Raveh Shoval, PhD; Phone Number: 97248537557; Email: shani@oncohost.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75204
      • Recruiting
      • Baylor Scott and White Research Institute
      • Contact: Pappu Himabindu; Email: Himabindu.Pappu@BSWHealth.org
      • Principal Investigator: Ronan J Kelly, MD MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population comprises 3 sub-populations:

Cohort 1 - Non-operable NSCLC (Stages IIIB to IV), receiving immune-check inhibitor (ICI) therapy [any combination of ICI / ICI ±Chemotherapy, and any line of treatment].

Cohort 2 - Operable NSCLC (Stages II-IIIA), receiving ICI in the neoadjuvant or adjuvant setting.

Cohort 3 - Sex and aged matched non-diseased volunteers.

Description

Inclusion Criteria:

• Provision of informed consent prior to any study-specific procedures.
• Male or female aged at least 18 years.
• ECOG PS - 0/1-2.

Exclusion Criteria:

• Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment.
• Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-operable NSCLC patients receiving ICI therapy; Patients with non-operable stage IIIB-IV NSCLC treated with immune check inhibitor anti cancer treatment as a standard of care	Other: blood, stool and tissue samples collection; blood, stool and tissue samples collection before and during the treatment, as applicable
Operable NSCLC Patients Receiving ICI as Neoadjuvant or Adjuvant Therapy; Patients with operable stage II-IIIA NSCLC, treated with immune check inhibitor in the neoadjuvant or adjuvant setting	Other: blood, stool and tissue samples collection; blood, stool and tissue samples collection before and during the treatment, as applicable
Healthy volunteers; Sex and aged matched non-diseased volunteers	Other: blood, stool and tissue samples collection; blood, stool and tissue samples collection before and during the treatment, as applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response (OR)	OR as defined by RECIST 1.1 or any other validated clinical scale for response	month 3
Overall response (OR)	OR as defined by RECIST 1.1 or any other validated clinical scale for response	month 6
Overall response (OR)	OR as defined by RECIST 1.1 or any other validated clinical scale for response	month 9
Overall response (OR)	OR as defined by RECIST 1.1 or any other validated clinical scale for response	month 12
Overall response (OR)	OR as defined by RECIST 1.1 or any other validated clinical scale for response	month 15
Overall response (OR)	OR as defined by RECIST 1.1 or any other validated clinical scale for response	month 18
Overall response (OR)	OR as defined by RECIST 1.1 or any other validated clinical scale for response	month 21
Overall response (OR)	OR as defined by RECIST 1.1 or any other validated clinical scale for response	month 24
Plasma proteomic profile	Plasma proteins measurments	Baseline, pre treatment
Plasma proteomic profile	Plasma proteins measurments	2(+/-1) weeks from first treatment
Plasma proteomic profile	Plasma proteins measurments	3 months
Plasma proteomic profile	Plasma proteins measurments	6 months
Plasma proteomic profile	Plasma proteins measurments	9 months
Plasma proteomic profile	Plasma proteins measurments	12 months
Plasma proteomic profile	Plasma proteins measurments	15 months
Plasma proteomic profile	Plasma proteins measurments	18 months
Plasma proteomic profile	Plasma proteins measurments	21 months
Plasma proteomic profile	Plasma proteins measurments	24 months
Epigenetic patterns	Characterization of Cell free DNA	Baseline, pre treatment
Epigenetic patterns	Characterization of Cell free DNA	2(+/-1) weeks from first treatment
Epigenetic patterns	Characterization of Cell free DNA	12 months
Epigenetic patterns	Characterization of Cell free DNA	24 months
ctDNA mutation analysis	ctDNA mutation analysis	immediately after surgery
Microbiome profiling	PBMC subpopulations exploration	Baseline, pre treatment
Microbiome profiling	PBMC subpopulations exploration	2(+/-1) weeks from first treatment
Microbiome profiling	PBMC subpopulations exploration	12 months
Microbiome profiling	PBMC subpopulations exploration	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	Documentation of Progression Free Survival (PFS) duration	From date of enrollment until the date of first documented progression, assessed up to 100 months
Overall Survival (OS)	Documentaion of Overall Survival (OS) duration	From date of enrollment until the date of death from any cause, assessed up to 100 month
Adverse Events (AE)	AE, as reported by the patients	3 months
Adverse Events (AE)	AE, as reported by the patients	6 months
Adverse Events (AE)	AE, as reported by the patients	9 months
Adverse Events (AE)	AE, as reported by the patients	12 months
Adverse Events (AE)	AE, as reported by the patients	15 monthst
Adverse Events (AE)	AE, as reported by the patients	18 months
Adverse Events (AE)	AE, as reported by the patients	21 months
Adverse Events (AE)	AE, as reported by the patients	24 months

Collaborators and Investigators

• Sponsor: OncoHost Ltd.
• Investigators: Principal Investigator: Ronan J Kelly, MD MBA, Chief of Oncology Baylor Scott & White Health System

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Anticipated): January 1, 2028
• Study Completion (Anticipated): June 30, 2028

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Estimate): February 20, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• 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
• Other Study ID Numbers: OH-HRPP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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