Status:
ACTIVE_NOT_RECRUITING
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 r...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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:
- 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
- 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
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2027
Estimated Enrollment :
681 Patients enrolled
Trial Details
Trial ID
NCT04810078
Start Date
May 21 2021
End Date
May 10 2027
Last Update
October 9 2025
Active Locations (89)
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1
Local Institution
Chicago, Illinois, United States, 60611
2
Local Institution - 0025
Buffalo, New York, United States, 14263
3
Local Institution - 0088
West Reading, Pennsylvania, United States, 19611
4
Local Institution - 0095
Capital Federal, Buenos Aires, Argentina, C1419AHN