A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
Nivolumab and rHuPH20: Specified dose on specified days
Nivolumab: Specified dose on specified days
Study 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Time-averaged serum concentration over 28 days (Cavgd28) — Up to 28 days
Trough serum concentration at steady-state (Cminss) — Up to 4 months
Trial sites (89)
Facility
City
Region
Status
Local Institution
Chicago
Illinois
Local Institution - 0025
Buffalo
New York
Local Institution - 0088
West Reading
Pennsylvania
Local Institution - 0095
Capital Federal
Buenos Aires
Local Institution - 0058
Mar del Plata
Buenos Aires
Local Institution - 0037
Pergamino
Buenos Aires
Local Institution - 0079
Parana
Córdoba Province
Local Institution - 0030
Río Cuarto
Córdoba Province
Local Institution - 0066
Viedma
Río Negro Province
Local Institution - 0038
Buenos Aires
Argentina
Local Institution - 0056
San Juan
Argentina
Local Institution - 0064
Curitiba
Paraná
Local Institution - 0107
Ijuí
Rio Grande do Sul
Local Institution - 0039
Porto Alegre
Rio Grande do Sul
Local Institution - 0071
Barretos
São Paulo
Local Institution - 0070
São José do Rio Preto
São Paulo
Local Institution - 0090
Rio de Janeiro
Brazil
Local Institution - 0081
São Paulo
Brazil
Local Institution - 0096
São Paulo
Brazil
Local Institution - 0084
Temuco
Araucania
Local Institution - 0005
Santiago
Santiago Metropolitan
Local Institution - 0104
Santiago
Santiago Metropolitan
Local Institution - 0076
Santiago
Santiago Metropolitan
Local Institution - 0077
Viña del Mar
Valparaiso
Local Institution - 0063
Brno
Czechia
Local Institution - 0036
Hradec Králové
Czechia
Local Institution - 0020
Olomouc
Czechia
Local Institution - 0099
Ostrava
Czechia
Local Institution - 0010
Prague
Czechia
Local Institution - 0106
Praha 8 Liben
Czechia
Local Institution - 0017
Tampere
Finland
Local Institution
Nice
France
Local Institution - 0051
Suresnes
France
Local Institution - 0068
Villejuif
France
Local Institution - 0060
Tallaght
Dublin
Local Institution - 0033
Cremona
Italy
Local Institution - 0008
Florence
Italy
Local Institution - 0027
Meldola
Italy
Local Institution - 0018
Milan
Italy
Local Institution
Milan
Italy
+ 49 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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