Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

ConditionSolid Cancers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Claudius Regaud

About this trial

This is a translational, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers.

The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.

Patients with any of the following tumor types may be enrolled in the trial:

* Non-Small Cell Lung Cancer (NSCLC), * Head and neck cancer, * Melanoma, * Bladder cancer, * Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option.

For each included patient, tumor biopsy specimens and blood samples will be collected at different time points.

All included patients will be followed-up until progression. After this date, survival data will be collected.

Eligibility criteria

Qualifiers

Age ≥18 years at the time of study entry.

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).

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.

Archived tumor specimen available or feasible for pre-treatment tumor biopsy.

Disqualifiers

Patient pregnant, or breast-feeding.

Uveal melanoma

Any condition contraindicated with tumor /blood sampling procedures required by the protocol.

Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).

Trial design

Treatments tested in this trial

  • Patients treated with immune checkpoint blockade

Treatment groups

770 Participants
are divided into 1 treatment group

Sponsors and collaborators