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JOURNAL ONKOLOGIE – STUDIE
PROPHETIC

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

Rekrutierend

NCT-Nummer:
NCT04056247

Studienbeginn:
Oktober 2019

Letztes Update:
29.08.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Lung Neoplasms, Melanoma, Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
OncoHost Ltd.

Collaborator:
-

Studienleiter

Alona Zer, MD
Principal Investigator
003 Rambam Medical Center
Michal Lotem, MD
Principal Investigator
001 Hadassah Medical Center
Jair Bar, MD
Principal Investigator
016 Sheba Medical Center
Maya Gottfried, MD
Principal Investigator
005 Meir Medical Center
Abed Agbaria, MD
Principal Investigator
004 Bnai Zion Medical Center
Ido Wolf, MD
Principal Investigator
002 Tel Aviv Sourasky Medical Center
Mahmud Abu-Amana, MD
Principal Investigator
007 Haemek Medical Center
Rivka Katsenelson, MD
Principal Investigator
008 Kaplan Medical Center
Alexander Yakobson, MD
Principal Investigator
009 Soroka Medical Center
Tatiana Harkovsky, MD
Principal Investigator
011 Barzilai Medical Center
Mor Moskovitz, MD
Principal Investigator
012 Rabin Medical Center
Elizabeta Dudnik, MD
Principal Investigator
013 Assuta Medical Center
Raya Leibowitz, MD
Principal Investigator
014 Shamir Medical Center
Adam Berger, MD
Principal Investigator
030 Rutgers Cancer Institute
Jose Lutzky, MD
Principal Investigator
032 University of Miami
Antony Magliocco, MD
Principal Investigator
015 Protean Biodiagnostics
Gillian Price, MD
Principal Investigator
020 Aberdeen Royal Infirmary
Helen Cheley
Principal Investigator
021 Swansea Bay UHB - Cancer Institute
Louise Medley, MD
Principal Investigator
022 Torbay and South Devon NHS foundation
Tom Geldart, MD
Principal Investigator
023 Royal Bournemouth General Hospital Dorset
Anirban Chatterjee, MD
Principal Investigator
024 The Shrewsbury and Telford Hospital
David Farrugia, MD
Principal Investigator
025 Cheltenham General Hospital
Andreas Polychronis, MD
Principal Investigator
026 Mount Vernon Cancer Centre
Andreas Polychronis, MD
Principal Investigator
027 Lister Hospital
Ari VanderWalde, MD
Principal Investigator
031 West Clinic
Davika Das, MD
Principal Investigator
033 VAHCS Birmingham
Alison Brewster, MD
Principal Investigator
051 Withybush Hospital Hawl Dda University Health Board
Adam Hassani
Principal Investigator
029 Sunderland Royal Hospital
Adam Hassani, MD
Principal Investigator
028 South Tyneside District
Andrew Conn, MD
Principal Investigator
050 Bradford Teaching Hospitals
Yanyan Lou, MD
Principal Investigator
034 Mayo Clinic
Igor Puzanov, MD
Principal Investigator
035 Roswell Park
Ernesto Bustinza, MD
Principal Investigator
153 Florida Cancer Specialists and Research Institute
Anita Sabichi, MD
Principal Investigator
036 Michael E Debakey VA Medical Center
Ronnie Shapira Frommer, MD
Principal Investigator
017 Sheba Medical Center
Ina Koch, PhD
Principal Investigator
040 Asklepios Klinik Gauting GmbH
Petros Christopoulos, MD
Principal Investigator
041 Thoraxklinik-Heidelberg gGmbH
Marina Messinger, MD
Principal Investigator
150 Northwest Community Healthcare
Sunil Patel, MD
Principal Investigator
151 CHRISTUS St. Michael Health System
William P Fusselman, MD
Principal Investigator
152 Physicians Clinic of Iowa
David Vecente, MD
Principal Investigator
044 Hospital Universitario Virgen Macarena

Kontakt

Studienlocations
(3 von 41)

Northwest Community Healthcare
60008 Rolling Meadows
United StatesRekrutierend» Google-Maps
Ansprechpartner:
So Hyeon Park
E-Mail: marina.messinger@gmail.com

Marina Messinger
Phone: 8476184358
» Ansprechpartner anzeigen
Helen Nassif Community Cancer Center
52403 Cedar Rapids
United StatesRekrutierend» Google-Maps
Ansprechpartner:
So Hyeon Park
E-Mail: wfusselman@ocofiowa.com

William Fusselman, MD
Phone: 3193697775
» Ansprechpartner anzeigen
Soroka Medical Center
Be'er Sheva
IsraelAktiv, nicht rekrutierend» Google-Maps
Bnai Zion Medical Center
Haifa
IsraelAktiv, nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

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

Studien-Arme

  • Newly diagnosed NSCLC stage IV
    Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.
  • NSCLC stage IV 2nd line and further of immunotherapy
    Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.
  • Malignant melanoma stage IV
    Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy.
  • Malignant melanoma stage IIIb-d
    Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy.
  • SCLC stage IV
    Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.

Geprüfte Regime

  • Plasma sample collection:
    Collect at least two plasma samples

Quelle: ClinicalTrials.gov


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