CompletedNot Applicable

A Study of Nivolumab Plus Ipilimumab in Participants With Renal Cell Cancer in the Real World Setting in Japan

Japan286 participantsStarted 2019-09-19

Plain-language summary

The purpose of the observational study is to evaluate the safety and effectiveness of combination therapy with nivolumab and ipilimumab in Japanese participants with advanced or metastatic renal cell carcinoma (aRCC) in the real-world setting in Japan.

Who can participate

Age range

20 Years

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.

Inclusion Criteria: * Histological confirmation of Renal Cell Carcinoma (RCC) * No prior systemic therapy for RCC * Participants who are planned to start treatment with nivolumab and ipilimumab regimen in the timeframe between after IRB approval to enrollment-end date * International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk category Intermediate/Poor Exclusion Criteria: * Participants who are enrolled in a post marketing safety study on nivolumab plus ipilimumab combination therapy in Japan * Pregnant and/or lactating women * Participants who are judged to be inappropriate by investigator Other protocol-defined inclusion/exclusion criteria apply.

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

Objective Response Rate (ORR)

Timeframe: Up to 5 years

Trial details

NCT IDNCT04043975

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-08-23

View on ClinicalTrials.gov More Advanced or Metastatic Renal Cell Carcinoma trials

Who can participate

Age range

20 Years

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.