Everolimus Modulation of Anti-tumor T CD4 Immune Responses

NCT ID: NCT02837757

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-12-18

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 .

Conditions

Metastatic Renal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biological samples

Intervention Type: OTHER

blood and tumor tissue samples

Interventions

Biological samples

blood and tumor tissue samples

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire de Besançon

Besançon, , France

Hôpital Nord Franche-Comté

Montbéliard, , France

Hôpital Européen Georges Pompidou

Paris, , France

Countries

France

Other Identifiers

API/2014/48

Identifier Type: -

Identifier Source: org_study_id