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TerminatedNCT02837757EMIRUpdated May 16, 2022

Everolimus Modulation of Anti-tumor T CD4 Immune Responses

An interventional study of Biological samples in Metastatic Renal Cancer, sponsored by Centre Hospitalier Universitaire de Besancon. Terminated at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

Why this study was terminated
difficulty of patient recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 .

02

Conditions studied

  • Metastatic Renal Cancer

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03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's enrollment of 14 is below the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    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.

    Other: Biological samples

Interventions

  • OtherBiological samples

    blood and tumor tissue samples

06

What researchers measure

Primary outcomes

  1. Change in regulatory T cell counts during treatment with everolimus

    Time frame: 9 months after everolimus initiation

07

Study locations

3 sites
  • Centre Hospitalier Universitaire de Besançon
    Besançon, France
  • Hôpital Nord Franche-Comté
    Montbéliard, France
  • Hôpital Européen Georges Pompidou
    Paris, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02837757
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jul 20, 2016
Start date
Nov 2015
Primary completion
Dec 18, 2019
Completion
Dec 18, 2019
Last update
May 16, 2022
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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