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 metastatic RCC
(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 and within
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 of
prior malignancy active within 2 years prior to randomization
- Active, known, or suspected autoimmune disease
- Known human immunodeficiency virus (HIV) positive with an acquired immunodeficiency
syndrome (AIDS) defining opportunistic infection within the last year, or a current
CD4 count < 350 cells/μL. Participants with HIV are eligible if:
1. They have received established antiretroviral therapy (ART) for at least 4 weeks
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 health
care provider
4. 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
- Serious or uncontrolled medical disorders including for example, active severe acute
respiratory syndrome coronavirus 2 (SAR-CoV-2) infection within approximately 4 weeks
prior to screening. In the case of prior SARS-CoV-2 infection, acute symptoms must
have resolved based on investigator clinical judgment and, in consultation with
Medical Monitor, there are no sequelae that would place the participant at a higher
risk of receiving investigational treatment to be eligible
- Prior treatment with an programmed death receptor-1 (anti-PD-1), programmed death
ligand-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 costimulation or
checkpoint pathways
- Treatment with any live attenuated vaccine within 30 days of first study treatment
Other protocol-defined inclusion/exclusion criteria apply
Recruiting
