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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histological confirmation of renal cell carcinoma (RCC) with a clear cell component,including participants who may also have sarcomatoid features

• Advanced RCC (not amenable to curative surgery or radiation therapy) or metastaticRCC (Stage IV)

• Measurable disease as defined by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria within 28 days prior to randomization

• Received no more than 2 prior systemic treatment regimens

• Intolerance or progression on or after the last treatment regimen received andwithin 6 months prior to randomization

• Karnofsky PS ≥ 70 at screening

• Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

• Untreated, symptomatic central nervous system (CNS) metastases

• Concurrent malignancy (present during screening) requiring treatment or history ofprior malignancy active within 2 years prior to randomization

• Active, known, or suspected autoimmune disease

• Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiencysyndrome (AIDS) defining opportunistic infection within the last year, or a currentCD4 count < 350 cells/μL. Participants with HIV are eligible if:

1. They have received established antiretroviral therapy (ART) for at least 4weeks prior to randomization

2. They continue on ART as clinically indicated while enrolled on study

3. CD4 counts and viral load are monitored per standard of care by a local healthcare provider

4. Inclusion of participants with HIV should be based on Investigator clinicaljudgment in consultation with the Medical Monitor NOTE: Testing for HIV must beperformed at sites where mandated locally. HIV-positive participants must beexcluded where mandated locally

• Serious or uncontrolled medical disorders including for example, active severe acuterespiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4weeks prior to screening. In the case of prior SARS-CoV-2 infection, acute symptomsmust have resolved based on investigator clinical judgment and, in consultation withMedical Monitor, there are no sequelae that would place the participant at a higherrisk of receiving investigational treatment to be eligible

• Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed deathligand-1 (anti-PD-L1), or cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4)antibody, or any other antibody or drug specifically targeting T-cell costimulationor checkpoint pathways

• Treatment with any live attenuated vaccine within 30 days of first study treatment

Other protocol-defined inclusion/exclusion criteria apply