In-depth Characterization of Circulating and Infiltrating Immune Subsets and Tumor Cells in Cancer Patients (FUTURE)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Not yet enrolling

Conditions: Breast Cancer; Urologic Cancer; Lung Cancer; Head and Neck Cancer; Liver Cancer

Treatments: Procedure: blood collection; Procedure: tissue specimen collection

Study type: Observational

Funder types: Other

Identifiers

NCT06827639

RCAPHM23-0388

2023-A02198-37 (Registry Identifier)

Details and patient eligibility

About

The aim of this study is to describe the tumor microenvironment of solid tumors and to understand the changes induced by anti-cancer treatments, particularly those developed by Innate Pharma. Innate Pharma is a biotechnology company which discovers and develops therapeutic antibodies that exploit the innate immune system to improve cancer treatment. Thanks to this study, it will be possible to correlate clinical and immunological characteristics with the patient's clinical features. The analyses generated will contribute to the design and improvement of innovative therapeutic antibodies acting on the immune system

Full description

Rationale:

The purpose of this study is to characterize the tumor and immune contexture and its circulating counterpart in cancer patients and to understand changes induced by anti-cancer treatments. We will therefore be able to correlate clinical and immunological characteristics with patient clinical status. We expect that the data generated will be used as a decision-support tool for the design and evaluation of new or improved immunotherapy.

Study objectives:

• Primary objectives:
• Identification and functional characterization of circulating and infiltrating immune subsets and tumor cells in cancer patients.
• Discovery and preclinical evaluation of new therapeutic targets in oncology.

Secondary objectives:

• To evaluate and compare the frequency, phenotype and functionality of leukocytes subsets in the tumor microenvironment, tumor-adjacent tissue and in peripheral blood.
• To evaluate the expression of proteins targeted by therapeutic antibodies on circulating and tissue-resident cells in cancer patients.
• To assess the impact of anti-cancer treatments (including but not limited to therapeutic antibodies or chemotherapy) on the tumor and peripheral microenvironment (e.g. frequency and phenotype of leukocyte subsets; expression of targeted proteins or their ligands).
• To identify correlation between tumor biomarkers / blood biomarkers and biological or clinical characteristics of cancer patients as well as their clinical response to treatment.
• To characterize ex vivo the modes of action of several anti-cancer treatments.

Study Design:

During this study, patients will not receive any investigational product. Patients are included within their usual schedule of appointments with their surgeon or oncologist. Treatment strategy (surgery, chemotherapy, immunotherapy...) will vary from indication to indication and will not be impacted by participation to this study.

Screening and sampling Period

For patients with solid tumor undergoing surgery (cohort 1), a maximum of 3 visits are planned during this period:

• A Screening visit for patient evaluation and inclusion/exclusion criteria review
• Visit 1: For blood sampling specifically for the study;
• Visit 2: For tumor sampling and blood sampling if not done at Visit 1. Fresh solid tumor lesions and normal adjacent tissue will be macroscopically selected from the resected tumor material by a pathologist. Samples will be collected according to decision of May 3, 2017 establishing a list of researches as mentioned by article L1121-1, paragraph 2° of the French public Health code, and will therefore only concern blood samples, as well tissues collected during surgeries.

The Screening visit and the Visit 1 could occur on the same day.

For patients with solid tumor registered for anti-PD1/PD-L1-based treatment and not undergoing surgery (cohort 2), a maximum of 3 visits are planned during this period:

• A Screening visit for patient evaluation and inclusion/exclusion criteria review.
• A Baseline (pre-treatment) visit for blood sampling specifically for the study.
• A Post-treatment (after immunotherapy administration) for blood sampling specifically for the study.

The Screening and Baseline visits could occur on the same day.

For hematological malignancies (cohort 3), a maximum of 2 visits are planned during this period:

• A Screening visit;
• Visit 1: for blood sampling specifically for the study. The Screening visit and the Visit 1 could occur on the same day.

Target patient population:

Age ≥ 18 years with one of the following cancer indication:

• Lung cancer,
• Head and neck cancer,
• Urologic cancer,
• Liver cancer,
• Colorectal and gastric cancer,
• Breast cancer,
• Lymphoma and leukemia

Enrollment: 640 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Histologic, cytologic or imaging confirmation of a malignancy in accordance with targeted indications
• Written informed consent signed from subject prior to performing any protocol-related procedures

Exclusion criteria

• Use of any investigational agent within 14 days prior first visit;
• Patient under guardianship/trusteeship or legally incapacitated person;
• Patient unable to understand read and/or sign an informed consent;
• Uncooperative or potentially non-compliant for the study or study procedures patient, or with foreseeable regular follow-up difficulties;
• Patient without Health insurance scheme or Universal Medical Coverage (CMU) or any equivalent scheme;
• Patients who are known to be HIV positive

Trial design

640 participants in 3 patient groups

Cohort 1 - Patients with solid tumor undergoing surgery

Description:

Cohort 1 (patients with solid tumor undergoing surgery): * Head and neck cancer: up to 80 patients * Urologic cancer: up to 160 patients * Liver cancer: up to 80 patients * Colorectal and gastric cancer: up to 80 patients * Breast cancer: up to 80 patients A maximum of 3 visits are planned : * Screening visit for patient evaluation and inclusion/exclusion criteria review * Visit 1: For blood sampling specifically for the study * Visit 2: For tumor sampling and blood sampling if not done at Visit 1 Fresh solid tumor lesions and normal adjacent tissue will be macroscopically selected from the resected tumor material by a pathologist. Samples will be collected according to decision of May 3, 2017 establishing a list of researches as mentioned by article L1121-1, paragraph 2° of the French public Health code, and will therefore only concern blood samples, as well tissues collected during surgeries. The Screening visit and the Visit 1 can occur on the same day.

Treatment:

Procedure: tissue specimen collection

Procedure: blood collection

Cohort 2 - Patients with solid tumor with anti-PD1/PD-L1 treatment and no surgery

Description:

* Lung cancer: up to 40 patients * Head and neck cancer: up to 40 patients a maximum of 3 visits are planned during this period: * A Screening visit for patient evaluation and inclusion/exclusion criteria review. * A Baseline visit (pre-treatment) visit for blood sampling specifically for the study * A post-treatment visit (after immunotherapy administration) for blood sampling specifically for the study The Screening and Baseline visits can occur on the same day.

Treatment:

Procedure: blood collection

Cohort 3 - Patients with hematological malignancies

Description:

- Lymphoma and leukemia: up to 80 patients A maximum of 2 visits are planned during this period: * A Screening visit * Visit 1: for blood sampling specifically for the study The Screening visit and the Visit 1 could occur on the same day.

Treatment:

Procedure: blood collection