Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and after surgery if adjuvant ICB treatment is also administered). 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 in a neo-adjuvant setting (whether in standard of care or within a clinical trial).
For each included patient, blood samples will be collected at different time points. Tumor samples will be made available for the research however, no biopsy will be performed specifically for this study.
All included patients will be followed up for 5 years after baseline.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with immune checkpoint blockade in neo-adjuvant (and possibly in adjuvant) setting | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients treated with immune checkpoint blockade in neo-adjuvant setting and possibly in adjuvant setting (if applicable) | Other | Blood samples will be collected at different time points:
A fragment of tumor samples will be analyzed as part of the research. They will be collected per SOC at the following timepoints:
|
| Measure | Description | Time Frame |
|---|---|---|
| - NSCLC / Head & Neck / Melanoma: Rate of major pathological response - Bladder cancer: rate of complete pathological response - Exploratory: rate of pathological response |
| 5 years per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | Time from inclusion until disease recurrence or progression according to investigator judgment, or death, whichever occurs first. Patients alive and without recurrence or progression are censored at last follow-up news or at initiation of new anticancer treatment (if applicable). | 5 years per patient |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Pierre DELORD, MD, Professor | Contact | +33 5 31 15 55 00 | delord.jean-pierre@iuct-oncopole.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Universitaire Du Cancer de Toulouse - Oncopole | Toulouse | 31059 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Overall survival (OS) |
Time from inclusion until death from any cause. Patients alive are censored at last follow-up news. |
| 5 years per patient |
| Chu Rangueil | Toulouse | 31400 | France |
|
| Hopital Larrey | Toulouse | 31400 | France |
|
| 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 |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided