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A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread - CA209-67T

Updated: 31 May, 2024   |

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3


  • Gender(s)

  • 18+

    Age Range

  • 3


  • Recruiting

Treatment Options

Study Arms
Experimental: Arm A
Biological: Nivolumab and rHuPH20
Active Comparator: Arm B
Biological: Nivolumab
Experimental: Arm C
Biological: Nivolumab and rHuPH20
Experimental: Arm D
Biological: Nivolumab and rHuPH20

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit 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

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Have questions? Call us at 900-150-160 or Email Us

Have questions?
Call us at 900-150-160 or Email Us