Understanding how cancer cells evade the immune system

Deciphering Mechanisms Underlying Cancer Immunogenicity

This study is trying to understand how cancer cells hide from the immune system by looking at blood and tumor samples from 900 patients with different types of solid tumors.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Claudius Regaud (other)
• Locations: 3 sites (Toulouse and 2 other locations)
• Trial ID: NCT03958240 on ClinicalTrials.gov

What this trial studies

This trial is a multicentric, prospective cohort study involving 900 patients with various solid tumors, including head and neck, ovarian, and cervical cancers, as well as glioblastoma. The study aims to investigate the expression of PD-1 in T cells to better understand cancer immunogenicity. Participants will provide biological specimens such as tumor and blood samples over a 5-year period. Each tumor type will be analyzed as an independent cohort to gather comprehensive data on immune response mechanisms.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed local or metastatic solid malignant tumors or pre-invasive cervical high-grade dysplasia.

Not a fit: Patients with a known history of viral infections like Hepatitis B, Hepatitis C, or HIV may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved immunotherapy strategies for patients with solid tumors.

How similar studies have performed: Other studies have shown promise in understanding immune evasion in cancer, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

1. 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)
2. Age ≥ 18 years at the time of study entry
3. Patient followed within a standard of care procedure or clinical trial
4. ECOG Performance status 0-2
5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
6. Patient affiliated to a Social Health Insurance in France
7. Patient may participate to other clinical trials

Exclusion Criteria:

1. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus
2. Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin \< 8g/dl)
3. Patient pregnant, or breast-feeding
4. 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
5. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship

Where this trial is running

Toulouse and 2 other locations

• Hopital Larrey — Toulouse, France (RECRUITING)
• Hopital Rangueil — Toulouse, France (RECRUITING)
• Institut Universitaire du Cancer Toulouse - Oncopole — Toulouse, France (RECRUITING)

Study contacts

• Study coordinator: Alejandra MARTINEZ

Conditions: Head and Neck Cancer, Ovarian Cancer, Cervical Cancer, Cervical Intraepithelial Neoplasia 3, Glioblastoma Multiforme of Brain Stem, Non Small Cell Lung Cancer, Anal Cancer