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

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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