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

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

The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage IV Non-small Cell Lung Cancer; Stage IV Small Cell Lung Cancer; Stage IV Malignant Melanoma; Stage III Unresectable Non-Small Cell Lung Cancer; Stage IIIb-d Malignant Melanoma
• Intervention / Treatment: Other: Plasma sample collection

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Germany
  • Gauting, Germany, 82131
    • Asklepois
  • Heidelberg, Germany, 69126
    • Thoraxklinik Heidelberg gGmbH
• Israel
  • Afula, Israel
    • HaEmek Medical Center
  • Ashkelon, Israel
    • Barzilai Medical Center
  • Beersheba, Israel
    • Soroka Medical Center
  • Be’er Ya‘aqov, Israel
    • Shamir Medical Center
  • Haifa, Israel
    • Rambam Medical Center
  • Haifa, Israel
    • Bnai Zion Medical Center
  • Jerusalem, Israel
    • Hadassah Medcial Center
  • Kfar Saba, Israel
    • Meir Medical Center
  • Petah Tikva, Israel
    • Rabin Medical Center
  • Rehovot, Israel
    • Kaplan Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center
  • Tel Aviv, Israel
    • Sheba Medical Center
  • Tel Aviv, Israel
    • Assuta Medical Cetner
  • Tel Litwinsky, Israel
    • Sheba Medical Center
• Spain
  • Seville, Spain
    • 044 Hospital Universitario Virgen Macarena
• United Kingdom
  • Aberdeen, United Kingdom
    • Aberdeen Royal Infirmary
  • Bournemouth, United Kingdom
    • Royal Bournemouth General Hospital
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Teaching Hospitals
  • Cheltenham, United Kingdom
    • Cheltenham General Hospital
  • Haverfordwest, United Kingdom, SA61 2PZ
    • Withybush Hospital
  • Northwood, United Kingdom
    • Mount Vernon Cancer Centre
  • Shrewsbury, United Kingdom
    • The Shrewsbury and Telford Hospital
  • South Shields, United Kingdom, NE34 0PL
    • South Tyneside
  • Stevenage, United Kingdom
    • Lister Hospital
  • Sunderland, United Kingdom, SR4 7TP
    • Sunderland Royal Hospital
  • Swansea, United Kingdom
    • Swansea Bay UHB Singleton Hospital
  • Torquay, United Kingdom
    • Torbay Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Birmingham VAHCS
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32827
      • Florida Cancer Specialist And Research Institute
    • Orlando, Florida, United States, 32827
      • Protean Biodiagnosics
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Northwest Community Healthcare
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Helen Nassif Community Cancer Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • West Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center
    • Texarkana, Texas, United States, 75503
      • 151-Christus Health St. Michael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1. Stage IV NSCLC patients treated with ICI or a combination of ICI and chemotherapy in any line of treatment, or with chemotherapy as a first line treatment.
2. Stage III unresectable NSCLC patients treated with ICI therapy or ICI in combination with chemotherapy.
3. Stage IV malignant melanoma patients treated with any regimen that includes ICI therapy as a monotherapy or in combination with targeted therapy in any line of treatment. In specific sites, Stage IV melanoma patients treated with targeted therapy (as a reference population).
4. Stage IIIb-d malignant melanoma patients treated with any regimen that includes ICI therapy as monotherapy or in combination with targeted therapy as adjuvant therapy.
5. Stage IV SCLC patients treated with any regimen of ICI, chemotherapy or combination of ICI and chemotherapy in any line of treatment.

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

• 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.
• At least one measurable lesion in order to enable the assessment of the response (except for stage IIIb-d malignant melanoma patients).

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage IV NSCLC patients; Stage IV NSCLC patients treated with ICI or a combination of ICI and chemotherapy in any line of treatment, or with chemotherapy as a first line treatment.	Other: Plasma sample collection; Collect at least two plasma samples
Stage III unresectable NSCLC patients; Patients with Stage III unresectable NSCLC treated with ICI therapy or ICI in combination with chemotherapy	Other: Plasma sample collection; Collect at least two plasma samples
Stage IV malignant melanoma patients; Stage IV malignant melanoma patients treated with any regimen that includes ICI therapy as a monotherapy or in combination with targeted therapy in any line of treatment. In specific sites, Stage IV melanoma patients treated with targeted therapy (as a reference population).	Other: Plasma sample collection; Collect at least two plasma samples
Stage IIIb-d malignant melanoma patients; Stage IIIb-d malignant melanoma patients treated with any regimen that includes ICI therapy as monotherapy or in combination with targeted therapy as adjuvant therapy.	Other: Plasma sample collection; Collect at least two plasma samples
Stage IV SCLC patients; Stage IV SCLC patients treated with any regimen of ICI, chemotherapy or combination of ICI and chemotherapy in any line of treatment.	Other: Plasma sample collection; Collect at least two plasma samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measured biological features at baseline (pre-treatment) and after 1st dose administration (on-treatment) and during treatment (optional)	Biological features are analyzed in biological samples taken from the patients as part of the study	Measured biological features are analyzed in samples taken at baseline (prior treatment) and after the 1st dose administration (on-treatment) and during treatment (optional)
Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care	Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care	Every 3 months or according to the standard of care
Progression Free Survival (PFS)	Collect Progression Free Survival (PFS) dates	At progression during treatment
Overall survival or last follow-up	Collect overall survival or last follow-up dates	Overall survival or last follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AE)	AE to treatment, as reported by the patient	Adverse events (AE) during treatment and until the end of study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AE)	AE, as reported by the patients	At second blood collection, 3 months and 6 months after treatment and EOS (2 years)
Progression Free Survival (PFS)	Collect Progression Free Survival (PFS) dates	At End of study (2 years)
Overall Survival (OS)	Collect Overall Survival (OS) dates	At End of study (2 years)
Duration of Response (DOR)	Collect Duration of Response (DOR) dates	At End of study (2 years)

Collaborators and Investigators

• Sponsor: OncoHost Ltd.
• Investigators: Principal Investigator: Jose Lutzky, MD, University of Miami; Principal Investigator: Michal Lotem, MD, Hadassah Medical Organization; Principal Investigator: Maya Gottfried, MD, Meir Medical Center; Principal Investigator: Alona Zer, MD, Rambam Health Care Campus; Principal Investigator: Jair Bar, MD, Sheba Medical Center; Principal Investigator: Abed Agbaria, MD, Bnai Zion Medical Center; Principal Investigator: Ido Wolf, MD, Tel-Aviv Sourasky Medical Center; Principal Investigator: Mahmud Abu-Amana, MD, HaEmek Medical Center; Principal Investigator: Rivka Katsenelson, MD, Kaplan Medical Center; Principal Investigator: Alexander Yakobson, MD, Soroka University Medical Center; Principal Investigator: Tatiana Harkovsky, MD, Barzilai Medical Center; Principal Investigator: Mor Moskovitz, MD, Rabin Medical Center; Principal Investigator: Elizabeta Dudnik, MD, Assuta Medical Center; Principal Investigator: Raya Leibowitz, MD, Assaf-Harofeh Medical Center; Principal Investigator: Adam Berger, MD, Rutgers Cancer Institute; Principal Investigator: Antony Magliocco, MD, Protean BioDiagnostics; Principal Investigator: Gillian Price, MD, Aberdeen Royal Infirmary; Principal Investigator: Helen Cheley, Swansea Bay UHB - Cancer Institute; Principal Investigator: Louise Medley, MD, Torbay and South Devon NHS foundation; Principal Investigator: Tom Geldart, MD, Royal Bournemouth General Hospital Dorset; Principal Investigator: Anirban Chatterjee, MD, The Shrewsbury and Telford Hospital; Principal Investigator: Sean Brown, MD, Gloucestershire Hospitals NHS Foundation Trust; Principal Investigator: Andreas Polychronis, MD, Mount Vernon Cancer Centre; Principal Investigator: Andreas Polychronis, MD, Lister Hospital; Principal Investigator: Ari VanderWalde, MD, West Clinic; Principal Investigator: Davika Das, MD, VAHCS Birmingham; Principal Investigator: Alison Brewster, MD, Withybush Hospital Hawl Dda University Health Board; Principal Investigator: Adam Hassani, Sunderland Royal Hospital; Principal Investigator: Adam Hassani, MD, South Tyneside District; Principal Investigator: Andrew Conn, MD, Bradford Teaching Hospitals; Principal Investigator: Yanyan Lou, MD, Mayo Clinic; Principal Investigator: Igor Puzanov, MD, Roswell Park; Principal Investigator: Ernesto Bustinza, MD, Florida Cancer Specialists and Research Institute; Principal Investigator: Huang Quillan, MD, Michael E. DeBakey VA Medical Center; Principal Investigator: Ronnie Shapira Frommer, MD, Sheba Medical Center; Principal Investigator: Astrid Ammendola, MD, Asklepios Klinik Gauting GmbH; Principal Investigator: Petros Christopoulos, MD, Thoraxklinik-Heidelberg gGmbH; Principal Investigator: Marina Messinger, MD, Northwest Community Healthcare; Principal Investigator: Sunil Patel, MD, CHRISTUS St. Michael Health System; Principal Investigator: Bharat P Jenigiri, MD, Physicians Clinic of Iowa; Principal Investigator: David Vecente, MD, Hospital Universitario Virgen Macarena; Principal Investigator: Eugenie Younger, MD, Gloucestershire Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Christopoulos P, Harel M, McGregor K, Brody Y, Puzanov I, Bar J, Elon Y, Sela I, Yellin B, Lahav C, Raveh S, Reiner-Benaim A, Reinmuth N, Nechushtan H, Farrugia D, Bustinza-Linares E, Lou Y, Leibowitz R, Kamer I, Zer Kuch A, Moskovitz M, Levy-Barda A, Koch I, Lotem M, Katzenelson R, Agbarya A, Price G, Cheley H, Abu-Amna M, Geldart T, Gottfried M, Tepper E, Polychronis A, Wolf I, Dicker AP, Carbone DP, Gandara DR. Plasma Proteome-Based Test for First-Line Treatment Selection in Metastatic Non-Small Cell Lung Cancer. JCO Precis Oncol. 2024 Mar;8:e2300555. doi: 10.1200/PO.23.00555.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: August 11, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 12, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Non-small Cell Lung Cancer; Small Cell Lung Cancer; Malignant Melanoma
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Melanoma
• Other Study ID Numbers: OH-HRPP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No