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

OncoHost

Status: Enrolling

Conditions: Stage IV Malignant Melanoma; Stage III Malignant Melanoma; Stage IV Non-small Cell Lung Cancer; Stage IV Small Cell Lung Cancer

Treatments: Other: Plasma sample collection

Study type: Observational

Funder types: Industry

Identifiers

NCT04056247

OH-HRPP-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

2,000 participants in 5 patient groups

Newly diagnosed NSCLC stage IV

Description:

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

Treatment:

Other: Plasma sample collection

NSCLC stage IV 2nd line and further of immunotherapy

Description:

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

Treatment:

Other: Plasma sample collection

Malignant melanoma stage IV

Description:

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

Treatment:

Other: Plasma sample collection

Malignant melanoma stage IIIb-d

Description:

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

Treatment:

Other: Plasma sample collection

SCLC stage IV

Description:

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

Treatment:

Other: Plasma sample collection