PROPHETIC: Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Overall response rate (ORR) at 3 months [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 [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 [At baseline (pre-therapy) and after 1st dose administration (post therapy)]
Changes in Blood levels of proteins representing the Host response
Other Outcome Measures
- Adverse Events (AE) [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) [At End of study (2 years)]
Collect Progression Free Survival (PFS) dates
- Overall Survival (OS) [At End of study (2 years)]
Collect Overall Survival (OS) dates
- Duration of Response (DOR) [At End of study (2 years)]
Collect Duration of Response (DOR) dates
Eligibility Criteria
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:
-
Absolute neutrophil count higher than 1500/mm3
-
Platelets count higher than 100,000/mm3
-
haemoglobin higher than 9 g/dL
-
Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham VAHCS | Birmingham | Alabama | United States | 35233 |
| 2 | Mayo Clinic | Jacksonville | Florida | United States | 32224 |
| 3 | University of Miami | Miami | Florida | United States | 33136 |
| 4 | Florida Cancer Specialist and Research Institute | Orlando | Florida | United States | 32827 |
| 5 | Protean Biodiagnosics | Orlando | Florida | United States | 32827 |
| 6 | Northwest Community Healthcare | Rolling Meadows | Illinois | United States | 60008 |
| 7 | Helen Nassif Community Cancer Center | Cedar Rapids | Iowa | United States | 52403 |
| 8 | Rutgers Cancer Institute | New Brunswick | New Jersey | United States | 08903 |
| 9 | Roswell Park | Buffalo | New York | United States | 14263 |
| 10 | West Clinic | Germantown | Tennessee | United States | 38138 |
| 11 | Michael E. Debakey VA Medical Center | Houston | Texas | United States | 77030 |
| 12 | Christus Health St. Michael | Texarkana | Texas | United States | 75503 |
| 13 | Assuta Medical Cetner | Tel Aviv | HaMerkaz | Israel | |
| 14 | Haemek Medical Center | Afula | Israel | ||
| 15 | Barzilai Medical Center | Ashkelon | Israel | ||
| 16 | Soroka Medical Center | Be'er Sheva | Israel | ||
| 17 | Shamir Medical Center | Be'er Ya'aqov | Israel | ||
| 18 | Bnai Zion Medical Center | Haifa | Israel | ||
| 19 | Rambam Medical Center | Haifa | Israel | ||
| 20 | Hadassah Medcial Center | Jerusalem | Israel | ||
| 21 | Meir medical center | Kfar Saba | Israel | ||
| 22 | Rabin Medical Center | Petah tikva | Israel | ||
| 23 | Kaplan Medical Center | Reẖovot | Israel | ||
| 24 | Assuta Medical Cetner | Tel Aviv | Israel | ||
| 25 | Sourasky Medical Center | Tel Aviv | Israel | ||
| 26 | Sheba medical center | Tel HaShomer | Israel | ||
| 27 | Aberdeen Royal Infirmary | Aberdeen | United Kingdom | ||
| 28 | Royal Bournemouth General Hospital | Bournemouth | United Kingdom | ||
| 29 | Bradford Teaching Hospitals | Bradford | United Kingdom | BD9 6RJ | |
| 30 | Cheltenham General Hospital | Cheltenham | United Kingdom | ||
| 31 | Withybush Hospital | Haverfordwest | United Kingdom | SA61 2PZ | |
| 32 | Mount Vernon Cancer Centre | Northwood | United Kingdom | ||
| 33 | The Shrewsbury and Telford Hospital | Shrewsbury | United Kingdom | ||
| 34 | South Tyneside | South Shields | United Kingdom | NE34 0PL | |
| 35 | Lister Hospital | Stevenage | United Kingdom | ||
| 36 | Sunderland Royal Hospital | Sunderland | United Kingdom | SR4 7TP | |
| 37 | Swansea Bay UHB Singleton Hospital | Swansea | United Kingdom | ||
| 38 | Torbay Hospital | Torquay | United Kingdom |
Sponsors and Collaborators
- OncoHost Ltd.
Investigators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- 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. Review.
- OH-HRPP-001