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

Centre Hospitalier Universitaire de Besancon

Status: Terminated

Conditions: Metastatic Renal Cancer

Treatments: Other: Biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02837757

API/2014/48

Details and patient eligibility

About

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 .

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Biological samples

Experimental group

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.

Treatment:

Other: Biological samples