Metastatic Renal CancerEMIRNCT02837757
Everolimus Modulation of Anti-tumor T CD4 Immune Responses
A study testing Biological samples in people with Metastatic Renal Cancer, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cancer
- What is being tested?
- Biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2015to 18 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Hospitalier Universitaire de Besançon
Besançon
Hôpital Nord Franche-Comté
Montbéliard
Hôpital Européen Georges Pompidou
Paris
About this study
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
- Being tested
- Biological samples
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesOther
blood and tumor tissue samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in regulatory T cell counts during treatment with everolimus
Measured: 9 months after everolimus initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startNov 2015
- Primary completion18 Dec 2019
- Study completion18 Dec 2019
Why it stopped: difficulty of patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837757
- Sponsor's protocol ID
- API/2014/48
- Acronym
- EMIR
- Status last verified
- May 2022
- First submitted
- 13 Jul 2016
- Last updated
- 16 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everolimus Modulation of Anti-tumor T CD4 Immune Responses
- ClinicalTrials.gov ID
- NCT02837757
- Acronym / sponsor ID
- EMIR / API/2014/48
- Conditions
- Metastatic Renal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty of patient recruitment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 18 Dec 2019 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological samples | Experimental | Other: Biological samplesBlood 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samplesblood and tumor tissue samples | Other | Biological samples |
Primary outcome
Change in regulatory T cell counts during treatment with everolimus
Time frame: 9 months after everolimus initiation
Results and safety
The study was stopped early (reason given: difficulty of patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples in people with Metastatic Renal Cancer, run by Centre Hospitalier Universitaire de Besancon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty of patient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in regulatory T cell counts during treatment with everolimus (time frame: 9 months after everolimus initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.