Deciphering Mechanisms Underlying Cancer Immunogenicity

Overview

This trial is a translational, open-label, multicentric, prospective cohort study of 1100 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors. The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial. Patients with any of the following tumor types may be enrolled in the trial: * Head and neck cancer, * Ovarian cancer, * Cervical cancer, * Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer), * Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer) Each tumor type will be considered as an independent cohort. For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected. Study participation of each patient will be 5 years.

Interventions

• Other Blood samples, tumor biopsy specimens and ascites samples will be collected.
  Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice) for a maximum follow-up period of 5 years from baseline: * at Baseline. * at every surgical procedure or tumor biopsy. * every 6 months (± 2 months) (only blood sample). * at the time of the progression or recurrence, additional samples will be collected, and optionally at the time of the following progressions or recurrences

Primary outcome measures

• Percentage of CD4 and CD8 T cells expressing PD-1 [Time frame: 5 years for each patient]

Secondary outcome measures (1)

• Rate of patients presenting a high Trm (Tissue resident memory) infiltrate in tumor samples [Time frame: 5 years for each patient]

Eligibility criteria

Inclusion criteria

• Patient with histologically documented local or metastatic solid malignant tumor (head and neck, ovarian, cervical, and other tumor types including, but not limited to glioblastoma, NSCLC and anal cancer) or patients with pre-invasive cervical high grade dysplasia (CIN II or III)
• Age ≥ 18 years at the time of study entry
• Patient followed within a standard of care procedure or clinical trial
• ECOG Performance status 0-2
• Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
• Patient affiliated to a Social Health Insurance in France
• Patient may participate to other clinical trials

Exclusion criteria

• Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus
• Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin < 8g/dl)
• Patient pregnant, or breast-feeding
• Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
• Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 3 centers

• Hopital Larrey — Toulouse
• Hopital Rangueil — Toulouse
• Institut Universitaire du Cancer Toulouse - Oncopole — Toulouse

Identifiers

NCT: NCT03958240 · 19 GENE 13

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗