Active — Not RecruitingPhase 3

A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

United States, Argentina681 participantsStarted 2021-05-21

Plain-language summary

The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. They have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization
✕. They continue on ART as clinically indicated while enrolled on study
✕. CD4 counts and viral load are monitored per standard of care by a local health care provider
✕. Inclusion of participants with HIV should be based on Investigator clinical judgment in consultation with the Medical Monitor NOTE: Testing for HIV must be performed at sites where mandated locally. HIV-positive participants must be excluded where mandated locally

What they're measuring

Time-averaged serum concentration over 28 days (Cavgd28)

Timeframe: Up to 28 days

Trough serum concentration at steady-state (Cminss)

Timeframe: Up to 4 months

Trial details

NCT IDNCT04810078

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-29

View on ClinicalTrials.gov More Clear Cell Renal Cell Carcinoma trials