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

Healthy Clinical Trial

— PROPHETIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736029
• Other study ID #: OH-HRPP-002
• Status: Recruiting
• Start date: November 7, 2022
• Est. completion date: June 30, 2028

Study information

• Verified date: February 2023
• Source: OncoHost Ltd.
• Contact: Galit Yahalom, PhD
• Phone: 97248537557
• Email: galit[@]oncohost.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 30, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Healthy
• Non Small Cell Lung Cancer

Intervention

Other:
• blood, stool and tissue samples collection
blood, stool and tissue samples collection before and during the treatment, as applicable

Locations

Country	Name	City	State
United States	Baylor Scott and White Research Institute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
OncoHost Ltd.

Country where clinical trial is conducted

United States, 

Outcome

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