Clinical trial NCT04056247: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stage IV Non-small Cell Lung Cancer
Stage IV Malignant Melanoma
Stage IV Small Cell Lung Cancer
Stage III Malignant Melanoma
Lead sponsor: OncoHost Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Overall response rate (ORR) at 3 months
timeFrame: At 3 months after therapy
measure: Overall response rate (ORR) at 6 months
timeFrame: At 6 months after therapy
measure: Changes in the blood levels of different proteins that represent the host response
timeFrame: At baseline (pre-therapy) and after 1st dose administration (post therapy)
Secondary outcomes:
Other outcomes:
measure: Adverse Events (AE)
timeFrame: At second blood collection, 3 months and 6 months after treatment and EOS (2 years)
measure: Progression Free Survival (PFS)
timeFrame: At End of study (2 years)
measure: Overall Survival (OS)
timeFrame: At End of study (2 years)
measure: Duration of Response (DOR)
timeFrame: At End of study (2 years)
Locations:
city: Birmingham
country: United States
facility: Birmingham VAHCS
state: Alabama
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Specialist and Research Institute
state: Florida
city: Orlando
country: United States
facility: Protean Biodiagnosics
state: Florida
city: Rolling Meadows
country: United States
facility: Northwest Community Healthcare
state: Illinois
city: Cedar Rapids
country: United States
facility: Helen Nassif Community Cancer Center
state: Iowa
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park
state: New York
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Houston
country: United States
facility: Michael E. Debakey VA Medical Center
state: Texas
city: Texarkana
country: United States
facility: 151-Christus Health St. Michael
state: Texas
city: Gauting
country: Germany
facility: Asklepois
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Afula
country: Israel
facility: Haemek Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medcial Center
city: Kfar Saba
country: Israel
facility: Meir medical center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Cetner
city: Tel Aviv
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Tel HaShomer
country: Israel
facility: Sheba medical center
city: Seville
country: Spain
facility: 044 Hospital Universitario Virgen Macarena
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals
city: Cheltenham
country: United Kingdom
facility: Cheltenham General Hospital
city: Haverfordwest
country: United Kingdom
facility: Withybush Hospital
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
city: Shrewsbury
country: United Kingdom
facility: The Shrewsbury and Telford Hospital
city: South Shields
country: United Kingdom
facility: South Tyneside
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Swansea
country: United Kingdom
facility: Swansea Bay UHB Singleton Hospital
city: Torquay
country: United Kingdom
facility: Torbay Hospital
Study officials:
affiliation: 003 Rambam Medical Center
name: Alona Zer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 001 Hadassah Medical Center
name: Michal Lotem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 016 Sheba Medical Center
name: Jair Bar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 005 Meir Medical Center
name: Maya Gottfried, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 004 Bnai Zion Medical Center
name: Abed Agbaria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 002 Tel Aviv Sourasky Medical Center
name: Ido Wolf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 007 Haemek Medical Center
name: Mahmud Abu-Amana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 008 Kaplan Medical Center
name: Rivka Katsenelson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 009 Soroka Medical Center
name: Alexander Yakobson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 011 Barzilai Medical Center
name: Tatiana Harkovsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 012 Rabin Medical Center
name: Mor Moskovitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 013 Assuta Medical Center
name: Elizabeta Dudnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 014 Shamir Medical Center
name: Raya Leibowitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 030 Rutgers Cancer Institute
name: Adam Berger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 032 University of Miami
name: Jose Lutzky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 015 Protean Biodiagnostics
name: Antony Magliocco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 020 Aberdeen Royal Infirmary
name: Gillian Price, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 021 Swansea Bay UHB - Cancer Institute
name: Helen Cheley
role: PRINCIPAL_INVESTIGATOR
affiliation: 022 Torbay and South Devon NHS foundation
name: Louise Medley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 023 Royal Bournemouth General Hospital Dorset
name: Tom Geldart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 024 The Shrewsbury and Telford Hospital
name: Anirban Chatterjee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 025 Cheltenham General Hospital
name: David Farrugia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 026 Mount Vernon Cancer Centre
name: Andreas Polychronis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 027 Lister Hospital
name: Andreas Polychronis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 031 West Clinic
name: Ari VanderWalde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 033 VAHCS Birmingham
name: Davika Das, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 051 Withybush Hospital Hawl Dda University Health Board
name: Alison Brewster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 029 Sunderland Royal Hospital
name: Adam Hassani
role: PRINCIPAL_INVESTIGATOR
affiliation: 028 South Tyneside District
name: Adam Hassani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 050 Bradford Teaching Hospitals
name: Andrew Conn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 034 Mayo Clinic
name: Yanyan Lou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 035 Roswell Park
name: Igor Puzanov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 153 Florida Cancer Specialists and Research Institute
name: Ernesto Bustinza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 036 Michael E Debakey VA Medical Center
name: Anita Sabichi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 017 Sheba Medical Center
name: Ronnie Shapira Frommer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 040 Asklepios Klinik Gauting GmbH
name: Ina Koch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 041 Thoraxklinik-Heidelberg gGmbH
name: Petros Christopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 150 Northwest Community Healthcare
name: Marina Messinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 151 CHRISTUS St. Michael Health System
name: Sunil Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 152 Physicians Clinic of Iowa
name: William P Fusselman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 044 Hospital Universitario Virgen Macarena
name: David Vecente, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.