Biomarkers and immune responses in early-stage solid cancers treated with immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective cohort follows patients with early-stage solid cancers treated with immune checkpoint inhibitors, with or without chemotherapy, in the neo-adjuvant setting. Blood samples are collected at multiple time points and tumor tissue is available for research, though no additional biopsy is required specifically for the trial. The goal is to identify immunological biomarkers and understand how the immune system responds to neo-adjuvant immunotherapy, potentially extending to adjuvant settings. Eligible cancers include NSCLC, head and neck cancer, melanoma, bladder cancer, and other solid tumors where IO is expected to work in the neo-adjuvant setting. The study analyzes immune dynamics related to treatment and tumor antigens to see how these factors relate to therapeutic efficacy.

Why it matters

Who can join: the full rules

* Inclusion Criteria:

  1. Age ≥18 years at the time of study entry.
  2. Patient with histologically documented early stage solid malignant tumor (NSCLC, head and neck cancer, melanoma (except uveal melanoma), bladder cancer or any other early stage solid tumor when I-O agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).
  3. Patient for whom a neo-adjuvant treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination with chemotherapy or other therapies has been decided.
  4. Availability of an archived tumor specimen (block FFPE) sampled prior to the start of the treatment.
  5. Treatment with ICB not yet started.
  6. ECOG Performance status 0-2.
  7. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
  8. Patient affiliated to a Social Health Insurance in France.
* Exclusion Criteria:

  1. Patient pregnant, or breast-feeding.
  2. Uveal melanoma
  3. Any condition contraindicated with tumor /blood sampling procedures required by the protocol.
  4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.
  6. 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.
  7. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Where it's running

• Institut Universitaire Du Cancer de Toulouse - Oncopole
  Toulouse, France Recruiting
• Chu Rangueil
  Toulouse, France Not yet recruiting
• Hopital Larrey
  Toulouse, France Not yet recruiting

Study contacts

• Study coordinator: Jean-Pierre DELORD, MD, Professor
• Email: delord.jean-pierre@iuct-oncopole.fr
• Phone: +33 5 31 15 55 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.