Back to resultsEverolimus Modulation of Anti-tumor T CD4 Immune Responses (EMIR)
Primary Purpose
Metastatic Renal Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological samples
Sponsored by
About this trial
This is an interventional other trial for Metastatic Renal Cancer
Eligibility 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.
Sites / Locations
- Centre Hospitalier Universitaire de Besançon
- Hôpital Nord Franche-Comté
- Hôpital Européen Georges Pompidou
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biological samples
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in regulatory T cell counts during treatment with everolimus
Secondary Outcome Measures
Full Information
NCT ID
NCT02837757
First Posted
July 13, 2016
Last Updated
May 10, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02837757
Brief Title
Everolimus Modulation of Anti-tumor T CD4 Immune Responses
Acronym
EMIR
Official Title
Everolimus Modulation of Anti-tumor T CD4 Immune Responses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
difficulty of patient recruitment
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 18, 2019 (Actual)
Study Completion Date
December 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biological samples
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Biological samples
Intervention Description
blood and tumor tissue samples
Primary Outcome Measure Information:
Title
Change in regulatory T cell counts during treatment with everolimus
Time Frame
9 months after everolimus initiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besançon
Country
France
Facility Name
Hôpital Nord Franche-Comté
City
Montbéliard
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Everolimus Modulation of Anti-tumor T CD4 Immune Responses
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