Everolimus Modulation of Anti-tumor T CD4 Immune Responses | NCT02837757

Studies
Everolimus Modulation of Anti-tumor T CD4 Immune Responses

NCT02837757

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Terminated

Last Update Posted

May 16, 2022Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Metastatic Renal Cancer

Interventions

Biological samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulty of patient recruitment

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Dec 18, 2019Actual

Completion Date

Dec 18, 2019Actual

First Submitted Date

Jul 13, 2016

First Submission Date that Met QC Criteria

Jul 15, 2016

First Posted Date

Jul 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2022

Last Update Posted Date

May 16, 2022Actual

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Biological samples	Other	blood and tumor tissue samples	Biological samples

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in regulatory T cell counts during treatment with everolimus		9 months after everolimus initiation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Besançon		Besançon			France
Hôpital Nord Franche-Comté

Condition Browse Module

MeSH Terms

ID	Term
D007680	Kidney Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

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