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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB2021-A02030-41 | Registry Identifier | Agence nationale de sécurité du médicament et des produits de santé |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| FONCER contre le cancer | UNKNOWN |
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This is a multicenter, exploratory, prospective study to identify angiogenesis and immune-related biomarkers predictive of progression free survival in patients with metastatic or advanced renal cell carcinoma treated by a combination of immunotherapy and antiangiogenic.
Recently, the management of renal cell carcinoma has undergone major changes with the emergence of combined therapies associating tyrosine kinase inhibitors (TKI) and immune checkpoint inhibitors (ICI) as first line treatments. However, there are no criteria to guide the choice between the different combinations validated and or between ICI combinations. Angiogenesis and immunity are intimately linked and some markers related have could be interesting to predict the efficacy of these combinations. Angiogenesis and immunity are highly related. This link may lead to new biomarkers to be explored to predict the response to TKI + ICI therapy combinations. On this basis, the investigators propose to conduct an open-label exploratory, multicenter prospective trial to study the association between angiogenesis and immune markers and the effect of combined TKI+ICI treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKI+ICI | Therapeutic combination tyrosine kinase inhibitor (TKI) + immune checkpoint inhibitors (ICI) |
| |
| ICI+ICI | Therapeutic combination with different immune checkpoint inhibitors (ICI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Biological | Systematic extra blood sampling at inclusion, 6 weeks after inclusion and in case of progression of the cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from inclusion to progression documented by imaging and based on RECIST 1.1 and iRECIST criteria or patient death. The iRECIST criteria use the same methods of monitoring tumor lesions as the RECIST 1.1 criteria but a confirmation 4-6 weeks after suspicion of progression is required to confirm or rule out progression because patients undergoing immunotherapy may present pseudo-progressions. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Observation of a partial or complete response according to RECIST 1.1 criteria during the follow-up | 24 months |
| Response duration | Time between the observation of an objective response (partial or complete according to RECIST 1.1 criteria) and the progression |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a metastatic or advanced renal cell carcinoma who will benefit of an ICI-TKI or ICI-ICI combination as a first-line treatment (according to the current guidelines at the time of inclusion).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natacha Nohilé | Contact | 33156095982 | natacha.nohile@aphp.fr | |
| Laetitia MAUGE, PharmD, PhD | Contact | 33156093905 | laetitia.mauge@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laetitia MAUGE, PharmD, PhD | Assitance Puplique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital européen Georges-Pompidou AP-HP | Recruiting | Paris | 75015 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Plasma + tumour tissue
| Tumour samples | Other | reuse of tumour tissue collect in usual patient care |
|
| 24 months |
| Hôpital Cochin - AP-HP | Recruiting | Paris | France |
|
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |