Everolimus Modulation of Anti-tumor T CD4 Immune Responses

Metastatic Renal Cancer Clinical Trial

— EMIR  

Official title:

Everolimus Modulation of Anti-tumor T CD4 Immune Responses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02837757
• Other study ID #: API/2014/48
• Status: Terminated
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 18, 2019

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 18, 2019
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Neoplasms
• Metastatic Renal Cancer

Intervention

Other:
• Biological samples
blood and tumor tissue samples

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon
France	Hôpital Nord Franche-Comté	Montbéliard
France	Hôpital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in regulatory T cell counts during treatment with everolimus		9 months after everolimus initiation