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

(PROPHETIC Trial)

Recruiting at 40 trial locations

Overseen By Shani Raveh Shoval, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OncoHost Ltd.

Disqualifiers: Other active malignancy, mental incompetence

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Tom Geldart, MD

Principal Investigator

023 Royal Bournemouth General Hospital Dorset

Adam Hassani, MD

Principal Investigator

028 South Tyneside District

Alison Brewster, MD

Principal Investigator

051 Withybush Hospital Hawl Dda University Health Board

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

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

Jair Bar, MD

Principal Investigator

016 Sheba Medical Center

Alona Zer, MD

Principal Investigator

003 Rambam Medical Center

Michal Lotem, MD

Principal Investigator

001 Hadassah 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

Mor Moskovitz, MD

Principal Investigator

012 Rabin Medical Center

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

027 Lister Hospital

Ari VanderWalde, MD

Principal Investigator

031 West Clinic

Davika Das, MD

Principal Investigator

033 VAHCS Birmingham

Adam Hassani

Principal Investigator

029 Sunderland Royal Hospital

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

Tatiana Harkovsky, MD

Principal Investigator

011 Barzilai Medical Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care treatment, including Immunotherapy or Immunotherapy + Chemotherapy, and provide blood samples for algorithm development

6 months

Regular visits as per standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including collection of ORR, AE, PFS, OS, and DOR data

2 years

Follow-up visits at 3 months, 6 months, and end of study

What Are the Treatments Tested in This Trial?

Interventions

• Plasma sample collection

How Is the Trial Designed?

Group I: SCLC stage IV Experimental Treatment 1 Intervention

Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.

Group II: Newly diagnosed NSCLC stage IV Experimental Treatment 1 Intervention

Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.

Group III: NSCLC stage IV 2nd line and further of immunotherapy Experimental Treatment 1 Intervention

Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.

Group IV: Malignant melanoma stage IV Experimental Treatment 1 Intervention

Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy.

Group V: Malignant melanoma stage IIIb-d Experimental Treatment 1 Intervention

Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy.

Who Is Running the Clinical Trial?

OncoHost Ltd.

Lead Sponsor

Trials

3

Recruited

3,400+