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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056247
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
OncoHost Ltd.

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

Condition or disease Intervention/treatment
Stage IV Non-small Cell Lung Cancer Stage IV Malignant Melanoma Stage IV Small Cell Lung Cancer Stage III Malignant Melanoma 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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023


Group/Cohort Intervention/treatment
Newly diagnosed NSCLC stage IV
Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
Other: Plasma sample collection
Collect at least two plasma samples

NSCLC stage IV 2nd line and further of immunotherapy
Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.
Other: Plasma sample collection
Collect at least two plasma samples

Malignant melanoma stage IV
Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy.
Other: Plasma sample collection
Collect at least two plasma samples

Malignant melanoma stage IIIb-d
Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy.
Other: Plasma sample collection
Collect at least two plasma samples

SCLC stage IV
Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
Other: Plasma sample collection
Collect at least two plasma samples




Primary Outcome Measures :
  1. Overall response rate (ORR) at 3 months [ Time Frame: At 3 months after therapy ]
    ORR as defined by RECIST 1.1 or other validated method for ORR evaluation

  2. Overall response rate (ORR) at 6 months [ Time Frame: At 6 months after therapy ]
    ORR as defined by RECIST 1.1 or other validated method for ORR evaluation

  3. Changes in the blood levels of different proteins that represent the host response [ Time Frame: At baseline (pre-therapy) and after 1st dose administration (post therapy) ]
    Changes in Blood levels of proteins representing the Host response


Other Outcome Measures:
  1. Adverse Events (AE) [ Time Frame: At second blood collection, 3 months and 6 months after treatment and EOS (2 years) ]
    AE, as reported by the patients

  2. Progression Free Survival (PFS) [ Time Frame: At End of study (2 years) ]
    Collect Progression Free Survival (PFS) dates

  3. Overall Survival (OS) [ Time Frame: At End of study (2 years) ]
    Collect Overall Survival (OS) dates

  4. Duration of Response (DOR) [ Time Frame: At End of study (2 years) ]
    Collect Duration of Response (DOR) dates


Biospecimen Retention:   Samples Without DNA
plasma samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
  2. Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.
  3. Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy.
  4. Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy.
  5. Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056247


Contacts
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Contact: Galit Yahalom, Ph.D. 97248537554 galit@oncohost.com
Contact: Shani Raveh, Ph.D. 97248537554 shani@oncohost.com

Locations
Show Show 38 study locations
Sponsors and Collaborators
OncoHost Ltd.
Investigators
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Principal Investigator: Mor Moskovitz, MD 003 Rambam Medical Center
Principal Investigator: Michal Lotem, MD 001 Hadassah Medical Center
Principal Investigator: Jair Bar, MD 006 Sheba Medical Center
Principal Investigator: Maya Gottfried, MD 005 Meir Medical Center
Principal Investigator: Abed Agbaria, MD 004 Bnai Zion Medical Center
Principal Investigator: Ido Wolf, MD 002 Tel Aviv Sourasky Medical Center
Principal Investigator: Mahmud Abu-Amana, MD 007 Haemek Medical Center
Principal Investigator: Rivka Katsenelson, MD 008 Kaplan Medical Center
Principal Investigator: Alexander Yakobson, MD 009 Soroka Medical Center
Principal Investigator: Tatiana Harkovsky, MD 011 Barzilai Medical Center
Principal Investigator: Ofer Rotem, MD 012 Rabin Medical Center
Principal Investigator: Ella Tepper, MD 013 Assuta Medical Center
Principal Investigator: Raya Leibowitz, MD 014 Shamir Medical Center
Principal Investigator: Adam Berger, MD 030 Rutgers Cancer Institute
Principal Investigator: Jose Lutzky, MD 032 University of Miami
Principal Investigator: Antony Magliocco, MD 015 Protean Biodiagnostics
Principal Investigator: Gillian Price, MD 020 Aberdeen Royal Infirmary
Principal Investigator: Helen Cheley 021 Swansea Bay UHB - Cancer Institute
Principal Investigator: Louise Medley, MD 022 Torbay and South Devon NHS foundation
Principal Investigator: Tom Geldart, MD 023 Royal Bournemouth General Hospital Dorset
Principal Investigator: Anirban Chatterjee, MD 024 The Shrewsbury and Telford Hospital
Principal Investigator: David Farrugia, MD 025 Cheltenham General Hospital
Principal Investigator: Andreas Polychronis, MD 026 Mount Vernon Cancer Centre
Principal Investigator: Andreas Polychronis, MD 027 Lister Hospital
Principal Investigator: Ari VanderWalde, MD 031 West Clinic
Principal Investigator: Davika Das, MD 033 VAHCS Birmingham
Principal Investigator: Alison Brewster, MD 051 Withybush Hospital Hawl Dda University Health Board
Principal Investigator: Adam Hassani 029 Sunderland Royal Hospital
Principal Investigator: Adam Hassani, MD 028 South Tyneside District
Principal Investigator: Andrew Conn, MD 050 Bradford Teaching Hospitals
Principal Investigator: Yanyan Lou, MD 034 Mayo Clinic
Principal Investigator: Igor Puzanov, MD 035 Roswell Park
Principal Investigator: Ernesto Bustinza, MD 153 Florida Cancer Specialists and Research Institute
Principal Investigator: Anita Sabichi, MD Michael E. DeBakey VA Medical Center
Publications:
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Responsible Party: OncoHost Ltd.
ClinicalTrials.gov Identifier: NCT04056247    
Other Study ID Numbers: OH-HRPP-001
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Melanoma
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas