Everolimus Modulation of Anti-tumor T CD4 Immune Responses (EMIR)
|ClinicalTrials.gov Identifier: NCT02837757|
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was: Recruiting
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Everolimus is an inhibitor of mammalian target of rapamycin, approved in patients with metastatic renal cell carcinoma.
The objective of this study is to investigated the influence of everolimus immune modulation on antitumor efficacy .
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cancer||Other: Biological samples||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Everolimus Modulation of Anti-tumor T CD4 Immune Responses|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||November 2018|
Experimental: Biological samples
Blood samples will be realized specifically to the study at inclusion (baseline before starting everolimus treatment), and then 3 months and 9 months (or at disease progression if occurs first) after initiation of everolimus treatment Peripheral blood mononuclear cell (PBMC) and serum will be collected.
Available tumor tissues samples will be collected.
Other: Biological samples
blood and tumor tissue samples
- Change in regulatory T cell counts during treatment with everolimus [ Time Frame: 9 months after everolimus initiation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837757
|Contact: Laura MANSI, Drfirstname.lastname@example.org|
|Contact: Antoine THIERY-VUILLEMIN, Dremail@example.com|
|Centre Hospitalier Universitaire de Besançon||Recruiting|
|Principal Investigator: Laura MANSI, Dr|
|Hôpital Nord Franche-Comté||Recruiting|
|Principal Investigator: Antoine Thiery-Vuillemin, Dr|
|Hôpital Européen Georges Pompidou||Not yet recruiting|
|Principal Investigator: Stephane OUDARD, Pr|