Clinical trial · Observational
Nivolumab in mRCC Patients: Treg Function, T-cell Access and NK Interactions to Predict and Improve Efficacy
NCT03891485CI-TRIAL-00087027REVOLUTIONcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The project aims to identify Nivolumab predictive biomarkers in metastatic renal cancer patients through functional evaluation of peripheral Tregs and NKs. Moreover the efficacy of new CXCR4 antagonists (PCT/IB2011/000120/ EP2528936B1/ US2013/0079292A1) will be ex vivo evaluated in modulating Tregs and NKs function
Conditions
Conditions (2)
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 Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| RCC | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunological and tumour characterization | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Tregs function on peripheral blood/neoplastic tissue from mRCC patients undergoing nivolumab treatment.
- timeFrame
- Evolution between inclusion up to 24 months
- description
- Treg function will be mesured as % inhibition of T-effector proliferation (Tregs/T-effector 1:1 ratio). %T-effector proliferation in the presence of patients derived Tregs (Tregs/T-effector 1:1). Ex vivo effect of CXCR4 antagonists ( PCT/IB2011/000120; EP 2 528 936 B1/US2013/0079292A1) and other Tregs targets antagonists (ICOS, CD39/CD73) or agonists (TLR7L) will be assessed to identify novel anti-PD1 resistance mechanisms.
- measure
- NK function/cytotoxicity on peripheral blood/neoplastic tissue from mRCC patients undergoing nivolumab treatment
- timeFrame
- Evolution between inclusion and up to 24 months
- description
- NK cytotoxicity will be measured as % NK cell degranulation (CD107a assay), intracellular staining Grz A and GrzB and intracellular cytokines, GM-CSF, IFNγ, IL-10, TNF. Ex vivo effect of CXCR4 antagonists will be evaluated on NK cytotoxicity.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Men and women with histological confirmation of advanced/metastatic RCC with not more than 2 previous therapy lines Inclusion Criteria: * Age ≥ 18 years-old. * Histology proven locally advanced (unresectable) or metastatic clear cell renal cell carcinoma (mccRCC). * Starting 2nd or 3rd line of treatment with nivolumab, everolimus or axitinib * Signed informed consent. Exclusion Criteria: * Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements. * Pregnant or breastfeeding woman
References
Publications (0)
Data not yet available
No reference posted for this study.