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

Stage IV Non-small Cell Lung Cancer Clinical Trial

— PROPHETIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04056247
• Other study ID #: OH-HRPP-001
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: October 1, 2029

Study information

• Verified date: August 2023
• Source: OncoHost Ltd.
• Contact: Shani Raveh Shoval, Ph.D.
• Phone: 97248537554
• Email: shani[@]oncohost.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.

Description:

The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records.

In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 1, 2029
• Est. primary completion date: October 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cancer patients with stage IV NSCLC or stage IV malignant melanoma

• Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response

• ECOG PS - 0/1-2

• Normal hematologic, renal and liver function:

1. Absolute neutrophil count higher than 1500/mm3

2. Platelets count higher than 100,000/mm3

3. haemoglobin higher than 9 g/dL

4. Creatinine concentration =1.4 mg/dL, or creatinine clearance higher than 40 mL/min

5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels = 3 times above the upper normal limit.

Exclusion Criteria:

• Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug

• Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.

Related Conditions & MeSH terms

• Lung Neoplasms
• Melanoma
• Small Cell Lung Carcinoma
• Stage III Malignant Melanoma
• Stage IV Non-small Cell Lung Cancer
• Stage IV Small Cell Lung Cancer

Intervention

Other:
• Plasma sample collection
Collect at least two plasma samples

Locations

Country	Name	City	State
Germany	Asklepois	Gauting
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg
Israel	Haemek Medical Center	Afula
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka Medical Center	Be'er Sheva
Israel	Shamir Medical Center	Be'er Ya'aqov
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medcial Center	Jerusalem
Israel	Meir medical center	Kfar Saba
Israel	Rabin Medical Center	Petah tikva
Israel	Kaplan Medical Center	Re?ovot
Israel	Assuta Medical Cetner	Tel Aviv
Israel	Sheba Medical Center	Tel Aviv
Israel	Sourasky Medical Center	Tel Aviv
Israel	Sheba medical center	Tel HaShomer
Spain	044 Hospital Universitario Virgen Macarena	Seville
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Royal Bournemouth General Hospital	Bournemouth
United Kingdom	Bradford Teaching Hospitals	Bradford
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	Withybush Hospital	Haverfordwest
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	The Shrewsbury and Telford Hospital	Shrewsbury
United Kingdom	South Tyneside	South Shields
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Sunderland Royal Hospital	Sunderland
United Kingdom	Swansea Bay UHB Singleton Hospital	Swansea
United Kingdom	Torbay Hospital	Torquay
United States	Birmingham VAHCS	Birmingham	Alabama
United States	Roswell Park	Buffalo	New York
United States	Helen Nassif Community Cancer Center	Cedar Rapids	Iowa
United States	West Clinic	Germantown	Tennessee
United States	Michael E. Debakey VA Medical Center	Houston	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Miami	Miami	Florida
United States	Rutgers Cancer Institute	New Brunswick	New Jersey
United States	Florida Cancer Specialist and Research Institute	Orlando	Florida
United States	Protean Biodiagnosics	Orlando	Florida
United States	Northwest Community Healthcare	Rolling Meadows	Illinois
United States	151-Christus Health St. Michael	Texarkana	Texas

Sponsors (1)

Lead Sponsor	Collaborator
OncoHost Ltd.

Countries where clinical trial is conducted

United States,  Germany,  Israel,  Spain,  United Kingdom, 

References & Publications (3)

Shaked Y, Bocci G, Munoz R, Man S, Ebos JM, Hicklin DJ, Bertolini F, D'Amato R, Kerbel RS. Cellular and molecular surrogate markers to monitor targeted and non-targeted antiangiogenic drug activity and determine optimal biologic dose. Curr Cancer Drug Targets. 2005 Nov;5(7):551-9. doi: 10.2174/156800905774574020. — View Citation

Shaked Y, Kerbel RS. Antiangiogenic strategies on defense: on the possibility of blocking rebounds by the tumor vasculature after chemotherapy. Cancer Res. 2007 Aug 1;67(15):7055-8. doi: 10.1158/0008-5472.CAN-07-0905. — View Citation

Shaked Y. Balancing efficacy of and host immune responses to cancer therapy: the yin and yang effects. Nat Rev Clin Oncol. 2016 Oct;13(10):611-26. doi: 10.1038/nrclinonc.2016.57. Epub 2016 Apr 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events (AE)	AE, as reported by the patients	At second blood collection, 3 months and 6 months after treatment and EOS (2 years)
Other	Progression Free Survival (PFS)	Collect Progression Free Survival (PFS) dates	At End of study (2 years)
Other	Overall Survival (OS)	Collect Overall Survival (OS) dates	At End of study (2 years)
Other	Duration of Response (DOR)	Collect Duration of Response (DOR) dates	At End of study (2 years)
Primary	Overall response rate (ORR) at 3 months	ORR as defined by RECIST 1.1 or other validated method for ORR evaluation	At 3 months after therapy
Primary	Overall response rate (ORR) at 6 months	ORR as defined by RECIST 1.1 or other validated method for ORR evaluation	At 6 months after therapy
Primary	Changes in the blood levels of different proteins that represent the host response	Changes in Blood levels of proteins representing the Host response	At baseline (pre-therapy) and after 1st dose administration (post therapy)