Metastatic Renal Cancer
Conditions
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 .
Interventions
OTHERBiological samples
blood and tumor tissue samples
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in regulatory T cell counts during treatment with everolimus | 9 months after everolimus initiation |
Countries
France
Outcome results
None listed