Everolimus Modulation of Anti-tumor T CD4 Immune Responses

NCT02837757 | Terminated

• 1 other identifier: API/2014/48
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Change in regulatory T cell counts during treatment with everolimus

  9 months after everolimus initiation

Study Arms (1)

Biological samples

EXPERIMENTAL

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.

Other: Biological samples

Interventions

Biological samples OTHER

blood and tumor tissue samples

Biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (3)

Centre Hospitalier Universitaire de Besançon

Besançon, France

Location

Hôpital Nord Franche-Comté

Montbéliard, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 20, 2016
• Study Start: November 1, 2015
• Primary Completion: December 18, 2019
• Study Completion: December 18, 2019
• Last Updated: May 16, 2022

Record last verified: 2022-05

Locations

FR (3)