CompletedNot Applicable

Nivolumab in mRCC Patients: Treg Function, T-cell Access and NK Interactions to Predict and Improve Efficacy

Italy200 participantsStarted 2016-12

Plain-language summary

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

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Tregs function on peripheral blood/neoplastic tissue from mRCC patients undergoing nivolumab treatment.

Timeframe: Evolution between inclusion up to 24 months

NK function/cytotoxicity on peripheral blood/neoplastic tissue from mRCC patients undergoing nivolumab treatment

Timeframe: Evolution between inclusion and up to 24 months

Trial details

NCT IDNCT03891485

SponsorNational Cancer Institute, Naples

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-01

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