CER San Juan | San Juan, Argentina
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About
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.
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Inclusion and exclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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:
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
Primary purpose
Allocation
Interventional model
Masking
632 participants in 4 patient groups
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Central trial contact
BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.
Data sourced from clinicaltrials.gov
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