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

OncoHost

Status: Active, not recruiting

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

Treatments: Other: Plasma sample collection

Study type: Observational

Funder types: Industry

Identifiers

NCT04056247

OH-HRPP-001

Details and patient eligibility

About

The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.

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: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Provision of informed consent prior to any study-specific procedures.

• Male or female aged at least 18 years.

• 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.

• At least one measurable lesion in order to enable the assessment of the response (except for stage IIIb-d malignant melanoma patients).

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

10,000 participants in 5 patient groups

Stage IV NSCLC patients

Description:

Stage IV NSCLC patients treated with ICI or a combination of ICI and chemotherapy in any line of treatment, or with chemotherapy as a first line treatment.

Treatment:

Other: Plasma sample collection

Stage III unresectable NSCLC patients

Description:

Patients with Stage III unresectable NSCLC treated with ICI therapy or ICI in combination with chemotherapy

Treatment:

Other: Plasma sample collection

Stage IV malignant melanoma patients

Description:

Stage IV malignant melanoma patients treated with any regimen that includes ICI therapy as a monotherapy or in combination with targeted therapy in any line of treatment. In specific sites, Stage IV melanoma patients treated with targeted therapy (as a reference population).

Treatment:

Other: Plasma sample collection

Stage IIIb-d malignant melanoma patients

Description:

Stage IIIb-d malignant melanoma patients treated with any regimen that includes ICI therapy as monotherapy or in combination with targeted therapy as adjuvant therapy.

Treatment:

Other: Plasma sample collection

Stage IV SCLC patients

Description:

Stage IV SCLC patients treated with any regimen of ICI, chemotherapy or combination of ICI and chemotherapy in any line of treatment.

Treatment:

Other: Plasma sample collection