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

Who is this study for? Adult patients with Metastatic and/or Unresectable Solid Malignant Tumor, Bladder Cancer, or any other Advanced Solid Tumor that are receiving Immune Checkpoint Blockade
What treatments are being studied? Biopsy
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This trial is a translational, open-label, multi-site, prospective cohort study of 520 patients 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Current treatment with ICB not yet started.

• Evaluable disease (measurable as per RECIST 1.1. or not).

• ECOG Performance status 0-2.

• Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.

• Patient affiliated to a Social Health Insurance in France.

Locations
Other Locations
France
Chu Rangueil
RECRUITING
Toulouse
Hopital Larrey
RECRUITING
Toulouse
Institut Universitaire Du Cancer de Toulouse - Oncopole
RECRUITING
Toulouse
Contact Information
Primary
Jean-Pierre DELORD, MD
delord.jean-pierre@iuct-oncopole.fr
05 31 15 55 00
Time Frame
Start Date: 2018-05-28
Estimated Completion Date: 2029-11
Participants
Target number of participants: 570
Treatments
Other: Patients treated with immune checkpoint blockade
Sponsors
Leads: Institut Claudius Regaud

This content was sourced from clinicaltrials.gov

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