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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04056247
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	OncoHost Ltd.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alona Zer, MDMichal Lotem, MDJair Bar, MDMaya Gottfried, MDAbed Agbaria, MDIdo Wolf, MDMahmud Abu-Amana, MDRivka Katsenelson, MDAlexander Yakobson, MDTatiana Harkovsky, MDMor Moskovitz, MDElizabeta Dudnik, MDRaya Leibowitz, MDAdam Berger, MDJose Lutzky, MDAntony Magliocco, MDGillian Price, MDHelen CheleyLouise Medley, MDTom Geldart, MDAnirban Chatterjee, MDDavid Farrugia, MDAndreas Polychronis, MDAndreas Polychronis, MDAri VanderWalde, MDDavika Das, MDAlison Brewster, MDAdam HassaniAdam Hassani, MDAndrew Conn, MDYanyan Lou, MDIgor Puzanov, MDErnesto Bustinza, MDAnita Sabichi, MDRonnie Shapira Frommer, MDIna Koch, PhDPetros Christopoulos, MDMarina Messinger, MDSunil Patel, MDWilliam P Fusselman, MDDavid Vecente, MD
Principal Investigator Affiliation	003 Rambam Medical Center001 Hadassah Medical Center016 Sheba Medical Center005 Meir Medical Center004 Bnai Zion Medical Center002 Tel Aviv Sourasky Medical Center007 Haemek Medical Center008 Kaplan Medical Center009 Soroka Medical Center011 Barzilai Medical Center012 Rabin Medical Center013 Assuta Medical Center014 Shamir Medical Center030 Rutgers Cancer Institute032 University of Miami015 Protean Biodiagnostics020 Aberdeen Royal Infirmary021 Swansea Bay UHB - Cancer Institute022 Torbay and South Devon NHS foundation023 Royal Bournemouth General Hospital Dorset024 The Shrewsbury and Telford Hospital025 Cheltenham General Hospital026 Mount Vernon Cancer Centre027 Lister Hospital031 West Clinic033 VAHCS Birmingham051 Withybush Hospital Hawl Dda University Health Board029 Sunderland Royal Hospital028 South Tyneside District050 Bradford Teaching Hospitals034 Mayo Clinic035 Roswell Park153 Florida Cancer Specialists and Research Institute036 Michael E Debakey VA Medical Center017 Sheba Medical Center040 Asklepios Klinik Gauting GmbH041 Thoraxklinik-Heidelberg gGmbH150 Northwest Community Healthcare151 CHRISTUS St. Michael Health System152 Physicians Clinic of Iowa044 Hospital Universitario Virgen Macarena
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany, Israel, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Small Cell Lung Cancer, Stage III Malignant Melanoma

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Other: - Plasma sample collection

Collect at least two plasma samples

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham VAHCS, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

Birmingham VAHCS

Birmingham 4049979, Alabama 4829764, 35233

Site Contact

Davika Das, MD

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