PROPHETIC: Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The goal of the study is to develop an algorithm that associates between biomarkers detected in biospecimen of NSCLC patients, and their:
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Response to treatment
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Clinical benefit parameters such as PFS and OS.
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Adverse events to immune check inhibitor therapy
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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 -
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Proteomic features (Plasma proteomics)
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Epigenetic patterns (cell free DNA)
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ctDNA mutation analysis
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PBMC subpopulations
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Microbiome profiling (Stool)
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Overall response (OR) [month 3]
OR as defined by RECIST 1.1 or any other validated clinical scale for response
- Overall response (OR) [month 6]
OR as defined by RECIST 1.1 or any other validated clinical scale for response
- Overall response (OR) [month 9]
OR as defined by RECIST 1.1 or any other validated clinical scale for response
- Overall response (OR) [month 12]
OR as defined by RECIST 1.1 or any other validated clinical scale for response
- Overall response (OR) [month 15]
OR as defined by RECIST 1.1 or any other validated clinical scale for response
- Overall response (OR) [month 18]
OR as defined by RECIST 1.1 or any other validated clinical scale for response
- Overall response (OR) [month 21]
OR as defined by RECIST 1.1 or any other validated clinical scale for response
- Overall response (OR) [month 24]
OR as defined by RECIST 1.1 or any other validated clinical scale for response
- Plasma proteomic profile [Baseline, pre treatment]
Plasma proteins measurments
- Plasma proteomic profile [2(+/-1) weeks from first treatment]
Plasma proteins measurments
- Plasma proteomic profile [3 months]
Plasma proteins measurments
- Plasma proteomic profile [6 months]
Plasma proteins measurments
- Plasma proteomic profile [9 months]
Plasma proteins measurments
- Plasma proteomic profile [12 months]
Plasma proteins measurments
- Plasma proteomic profile [15 months]
Plasma proteins measurments
- Plasma proteomic profile [18 months]
Plasma proteins measurments
- Plasma proteomic profile [21 months]
Plasma proteins measurments
- Plasma proteomic profile [24 months]
Plasma proteins measurments
- Epigenetic patterns [Baseline, pre treatment]
Characterization of Cell free DNA
- Epigenetic patterns [2(+/-1) weeks from first treatment]
Characterization of Cell free DNA
- Epigenetic patterns [12 months]
Characterization of Cell free DNA
- Epigenetic patterns [24 months]
Characterization of Cell free DNA
- ctDNA mutation analysis [immediately after surgery]
ctDNA mutation analysis
- Microbiome profiling [Baseline, pre treatment]
PBMC subpopulations exploration
- Microbiome profiling [2(+/-1) weeks from first treatment]
PBMC subpopulations exploration
- Microbiome profiling [12 months]
PBMC subpopulations exploration
- Microbiome profiling [24 months]
PBMC subpopulations exploration
Other Outcome Measures
- Progression Free Survival (PFS) [From date of enrollment until the date of first documented progression, assessed up to 100 months]
Documentation of Progression Free Survival (PFS) duration
- Overall Survival (OS) [From date of enrollment until the date of death from any cause, assessed up to 100 month]
Documentaion of Overall Survival (OS) duration
- Adverse Events (AE) [3 months]
AE, as reported by the patients
- Adverse Events (AE) [6 months]
AE, as reported by the patients
- Adverse Events (AE) [9 months]
AE, as reported by the patients
- Adverse Events (AE) [12 months]
AE, as reported by the patients
- Adverse Events (AE) [15 monthst]
AE, as reported by the patients
- Adverse Events (AE) [18 months]
AE, as reported by the patients
- Adverse Events (AE) [21 months]
AE, as reported by the patients
- Adverse Events (AE) [24 months]
AE, as reported by the patients
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of informed consent prior to any study-specific procedures.
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Male or female aged at least 18 years.
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ECOG PS - 0/1-2.
Exclusion Criteria:
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Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of treatment.
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Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor Scott and White Research Institute | Dallas | Texas | United States | 75204 |
Sponsors and Collaborators
- OncoHost Ltd.
Investigators
- Principal Investigator: Ronan J Kelly, MD MBA, Chief of Oncology Baylor Scott & White Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OH-HRPP-002