Clinical trial · Interventional
Everolimus Modulation of Anti-tumor T CD4 Immune Responses
NCT02837757CI-TRIAL-00058490EMIRterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficulty of patient recruitment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Renal Cancer | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological samples | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological samples
- description
- 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.
- interventionNames
- Other: Biological samples
Primary outcomes (1)
- measure
- Change in regulatory T cell counts during treatment with everolimus
- timeFrame
- 9 months after everolimus initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.