Monitoring immune responses and biomarkers in cancer 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 trial is a multi-site, prospective cohort study involving 520 patients with advanced solid cancers who are receiving immune checkpoint blockade therapy. The aim is to identify and monitor immunological biomarkers that correlate with therapeutic responses and potential toxicities associated with treatments like anti-PD-1, anti-PD-L1, and anti-CTLA-4. Patients will have tumor biopsies and blood samples collected at various time points, and they will be followed until disease progression. The study focuses on several types of cancers, including non-small cell lung cancer, melanoma, and bladder cancer.

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 metastatic and/or unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option).
3. Patient for which a 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 has been decided.
4. Archived tumor specimen available or feasible for pre-treatment tumor biopsy.
5. Current treatment with ICB not yet started.
6. Evaluable disease (measurable as per RECIST 1.1. or not).
7. ECOG Performance status 0-2.
8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
9. 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

• Hopital Larrey
  Toulouse, France Recruiting
• Institut Universitaire Du Cancer de Toulouse - Oncopole
  Toulouse, France Recruiting
• Chu Rangueil
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Jean-Pierre DELORD, MD
• Email: delord.jean-pierre@iuct-oncopole.fr
• Phone: 05 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.