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Everolimus Modulation of Anti-tumor T CD4 Immune Responses (EMIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in regulatory T cell counts during treatment with everolimus [ Time Frame: 9 months after everolimus initiation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Performance status ECOG-WHO 0, 1 or 2
  • Metastatic renal cancer
  • Patient candidate to everolimus treatment
  • signed written informed consent
  • fertile women with adequate contraception during the study and until 8 weeks after stopping treatment

Exclusion Criteria:

  • Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
  • History of immune deficiency
  • Hypersensitivity against rapamycin and derived
  • Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
  • Active autoimmune diseases, HIV, hepatitis C or B virus
  • Patients with any medical or psychiatric condition or disease,
  • Patients under guardianship, curatorship or under the protection of justice.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837757


Contacts
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Contact: Laura MANSI, Dr mansi.laura@gmail.com
Contact: Antoine THIERY-VUILLEMIN, Dr athieryvuillemin@chu-besancon.fr

Locations
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France
Centre Hospitalier Universitaire de Besançon Recruiting
Besançon, France
Principal Investigator: Laura MANSI, Dr         
Hôpital Nord Franche-Comté Recruiting
Montbéliard, France
Principal Investigator: Antoine Thiery-Vuillemin, Dr         
Hôpital Européen Georges Pompidou Not yet recruiting
Paris, France
Principal Investigator: Stephane OUDARD, Pr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02837757    
Other Study ID Numbers: API/2014/48
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases