An Experimental Medicine Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Solid Tumours.

NCT05133128 | Terminated

• 1 other identifier: 2021-A01796-35
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to gain knowledge concerning expression of immune markers on immune cell subpopulation of PBMCs from subjects without cancer diagnosis and cancer patients. Few studies have addressed the question of the difference of peripheric immune cells between these two populations without a specific focus on an immune cell population or an indication, and with a multiparametic approach. The present study will combine phenotypic (using cell population markers and immune checkpoints) and functional analyses toallow to better interpret non-clinical results obtained with either subjects without cancer or cancer patient material and provide rationale to use material from subjects without cancer diagnosis for functional tests. It would also argument a go to healthy volunteer's clinical trials for assessing peripheral pharmacodynamic (PD), receptor occupancy (RO) and safety (Cytokine release syndrome, CRS), in the context of early drug development in immuno-oncology. Finally, generated data will be used to feed quantitative system pharmacology (QSP) models to increase their robustness and better predict drug pharmacology in humans.

Conditions

Immune System

Keywords

PBMC; cancer

Outcome Measures

Primary Outcomes (1)

• Standard differential blood count

  flow cytometry analysis

  1 day

Study Arms (1)

PATIENTS with cancer and HEALTHY VOLUNTEERS

OTHER

* Cohort 1: Patients with Non-Small Cell Lung cancer (25 patients) * Cohort 2: Patients with Colorectal cancer (25 patients) * Cohort 3: Patients with Pancreatic cancer (25 patients) * Cohort 4: Patients with Liver cancer (25 patients) * Cohort 5: Patients with Gastric cancer/cholangiocarcinoma (25 patients) * Cohort 6: Healthy volunteers (25 subjects)

Other: blood samples

Interventions

blood samples OTHER

blood samples

PATIENTS with cancer and HEALTHY VOLUNTEERS

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participating subjects are able to provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.
• Men and women must be of 45 to 70 years of age on the day the consent is signed. Non-cancer subjects should be age matched by +/- 5 years with the cancer patient population.
• Subject must have a Negative HIV
• Adequate hematological parameters as assessed by laboratory tests within 21 days for cancer patients and 96 hours for healthy volunteers prior to the day of blood withdrawal:
• Absolute Neutrophil Count (ANC) ≥1500/µL
• Platelet count ≥100 000/µL, criteria must be met without transfusion and thrombopoietin for at least two weeks prior to the day of blood withdrawal
• Hemoglobin ≥9g/dL, criteria must be met without transfusion and erythropoietin for at least two weeks prior to the day of blood withdrawal
• Physical ability to tolerate a 60 ml-blood sampling.
• Subjects affiliated to a social security regimen or beneficiary of the same according to local requirements
• Patients currently off treatment with histologically or cytologically confirmed following diagnosis:
• Cohort 1: Unresectable, locally advanced or metastatic Non-Small Cell Lung cancer after at least 1 or 2 standard treatment lines (including 1 line with Immune Checkpoint Inhibitor) and being scheduled for a new anti-cancer treatment after progression
• Cohort 2: Unresectable, locally advanced or metastatic Colorectal cancer after at least 2 treatment lines
• Cohort 3: Unresectable, locally advanced or metastatic Pancreatic cancer after at least 1 or 2 treatment lines
• Cohort 4: Unresectable, locally advanced or metastatic Liver cancer before or after at least 1 treatment line
• Cohort 5: Unresectable, locally advanced or metastatic Gastric cancer after at least 1 treatment line Unresectable, locally advanced or metastatic Cholangiocarcinoma before or after at least 1 treatment line

Sponsors & Collaborators

• Servier: lead

Study Sites (2)

Centre Georges Francois Leclerc

Dijon, 21000, France

Location

CIC du CHU

Dijon, 21000, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François GHIRINGHELLI, PU-PH

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 24, 2021
• Study Start: November 25, 2021
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

FR (2)