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

• ClinicalTrials.gov Identifier: NCT04056247
• Recruitment Status: Recruiting
• First Posted: August 14, 2019
• Last Update Posted: August 29, 2023
• Sponsor: OncoHost Ltd.
• Information provided by (Responsible Party): OncoHost Ltd.

Tracking Information

• First Submitted Date: August 11, 2019
• First Posted Date: August 14, 2019
• Last Update Posted Date: August 29, 2023
• Actual Study Start Date: October 1, 2019
• Estimated Primary Completion Date: October 1, 2029 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 13, 2019)

• 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
• 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
• 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: September 1, 2020)

• 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
• Progression Free Survival (PFS) [ Time Frame: At End of study (2 years) ]
  Collect Progression Free Survival (PFS) dates
• Overall Survival (OS) [ Time Frame: At End of study (2 years) ]
  Collect Overall Survival (OS) dates
• Duration of Response (DOR) [ Time Frame: At End of study (2 years) ]
  Collect Duration of Response (DOR) dates

Original Other Pre-specified Outcome Measures (submitted: August 13, 2019)

Adverse Events (AE) [ Time Frame: At second blood collection, 3 months and 6 months after treatment ]

AE, as reported by the patients

Descriptive Information

• Brief Title: Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
• Official Title: PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
• 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.

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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

plasma samples.

• 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.

Condition

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

Intervention

Other: Plasma sample collection

Collect at least two plasma samples

Study Groups/Cohorts

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

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 13, 2019): 2000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2029
• Estimated Primary Completion Date: October 1, 2029 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Shani Raveh Shoval, Ph.D.; 97248537554; shani@oncohost.com

• Listed Location Countries: Germany, Israel, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT04056247
• Other Study ID Numbers: OH-HRPP-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: OncoHost Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: OncoHost Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alona Zer, MD; 003 Rambam Medical Center
• Principal Investigator: Michal Lotem, MD; 001 Hadassah Medical Center
• Principal Investigator: Jair Bar, MD; 016 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: Mor Moskovitz, MD; 012 Rabin Medical Center
• Principal Investigator: Elizabeta Dudnik, 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; 036 Michael E Debakey VA Medical Center
• Principal Investigator: Ronnie Shapira Frommer, MD; 017 Sheba Medical Center
• Principal Investigator: Ina Koch, PhD; 040 Asklepios Klinik Gauting GmbH
• Principal Investigator: Petros Christopoulos, MD; 041 Thoraxklinik-Heidelberg gGmbH
• Principal Investigator: Marina Messinger, MD; 150 Northwest Community Healthcare
• Principal Investigator: Sunil Patel, MD; 151 CHRISTUS St. Michael Health System
• Principal Investigator: William P Fusselman, MD; 152 Physicians Clinic of Iowa
• Principal Investigator: David Vecente, MD; 044 Hospital Universitario Virgen Macarena

• PRS Account: OncoHost Ltd.
• Verification Date: August 2023