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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with immune checkpoint blockade | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients treated with immune checkpoint blockade | Other | Tumor biopsy specimens and blood samples will be collected at different time points:
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of objective response (complete or partial response) | Response will be assessed according to RECIST 1.1 / investigator judgment | 18 months by patient |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first. | 18 months by patient | |
| Anti-tumor immune responses under immunotherapy defined by investigator judgment and/or iRECIST criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Pierre DELORD, MD | Contact | 05 31 15 55 00 | delord.jean-pierre@iuct-oncopole.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Larrey | Recruiting | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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|
| 18 months by patient |
| Immune related adverse event (irAE) will be evaluated using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 | 12 months by patient |
| Institut Universitaire Du Cancer de Toulouse - Oncopole | Recruiting | Toulouse | 31059 | France |
|
| Chu Rangueil | Recruiting | Toulouse | France |
|
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |