Kidney Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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:

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

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

632

Study ID:

NCT04810078

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 102 Locations for this study

See Locations Near You

Local Institution
Chicago Illinois, 60611, United States More Info
Site 0045
Contact
Local Institution - 0025
Buffalo New York, 14263, United States
Local Institution - 0088
West Reading Pennsylvania, 19611, United States
Local Institution - 0038
Ciudad Autonoma de BuenosAires Buenos Aires, C1426, Argentina
Local Institution - 0058
Mar Del Plata Buenos Aires, 7600, Argentina
Local Institution - 0037
Pergamino Buenos Aires, B2700, Argentina
Local Institution - 0079
Parana Cordoba, 5000, Argentina
Cent Priv RMI Rio Cuarto SA II
Rio Cuarto Cordoba, 5800, Argentina More Info
Ignacio Magri, Site 0030
Contact
+5493585628491
Local Institution - 0066
Viedma RIO Negro, 8500, Argentina
Local Institution - 0056
San Juan , J5402, Argentina
Local Institution - 0064
Curitiba Parana, 80520, Brazil
Local Institution - 0011
Ijui RIO Grande DO SUL, 98700, Brazil
Local Institution - 0107
Ijui Rio Grande Do Sul, 98700, Brazil
Local Institution - 0039
Porto Alegre RIO Grande DO SUL, 91350, Brazil
Local Institution - 0071
Barretos Sao Paulo, 01478, Brazil
Local Institution - 0070
Sao Jose Do Rio Preto Sao Paulo, 15090, Brazil
Local Institution - 0090
Rio de Janeiro , 20230, Brazil
Local Institution - 0095
Sao Paulo , 01.30, Brazil
Local Institution - 0081
Sao Paulo , 01246, Brazil
Local Institution - 0096
Sao Paulo , 01327, Brazil
Local Institution - 0084
Temuco Araucania, 0, Chile
Local Institution - 0005
Santiago de Chile Metropolitana, 0, Chile
Local Institution - 0104
Santiago de Chile Metropolitana, 75006, Chile
Local Institution - 0076
Santiago Metropolitana, 75009, Chile
Local Institution - 0077
Vina del Mar Valparaiso, 25205, Chile
Local Institution - 0063
Brno , 65653, Czechia
Local Institution - 0036
Hradec Kralove , 500 0, Czechia
Local Institution - 0020
Olomouc , 77900, Czechia
Local Institution - 0099
Ostrava , 708 5, Czechia
Local Institution - 0010
Prague , 140 5, Czechia
Local Institution - 0106
Praha 8 Liben , 18081, Czechia
Local Institution
Jyvaskyla , 40620, Finland
Local Institution - 0080
Kuopio , 70029, Finland
Local Institution - 0017
Tampere , 33521, Finland
Local Institution - 0047
Turku , 20520, Finland
Local Institution - 0073
Lyon , 69373, France
Local Institution
Nice cedex 2 , 6189, France More Info
Site 0029
Contact
Local Institution - 0051
Suresnes , 92151, France
Local Institution
Toulouse , 31059, France
Local Institution - 0068
Villejuif , 94800, France
Local Institution - 0060
Tallaght Dublin, 0, Ireland
Local Institution
Cork , 1111, Ireland
Local Institution
Dublin , 9, Ireland
Local Institution - 0033
Cremona , 26100, Italy
Local Institution - 0008
Firenze , 50134, Italy
Local Institution - 0027
Meldola , 47014, Italy
Local Institution
Milano , 20133, Italy More Info
Site 0046
Contact
Local Institution - 0018
Milano , 20141, Italy
Local Institution - 0014
Padova , 35128, Italy
Local Institution - 0082
Parma , 43126, Italy
Local Institution - 0092
Pavia , 27100, Italy
Local Institution
Pisa , 56126, Italy
Local Institution - 0100
Roma , 00168, Italy
Local Institution - 0091
Rome , 00152, Italy
Local Institution - 0057
Terni , 05100, Italy
Local Institution - 0101
Torreon Coahuila, 27010, Mexico
Local Institution - 0089
Tlalpan Distrito Federal, 14080, Mexico
Local Institution - 0103
Monterrey Nuevo LEON, 64460, Mexico
Local Institution - 0031
Monterrey Nuevo LEON, 64710, Mexico
Local Institution - 0065
Queretaro , 76000, Mexico
Local Institution - 0085
Queretaro , 76090, Mexico
Local Institution - 0105
San Luis Potosi , 78200, Mexico
Auckland District Health Board-Auckland City Hospital
Auckland , 1023, New Zealand More Info
Simon Fu, Site 0053
Contact
6493074949
Waikato Hospital
Hamilton , 3204, New Zealand More Info
Alvin Tan, Site 0041
Contact
6478398899
Palmerston North Hospital
Palmerston North , 4414, New Zealand More Info
Navin Wewala, Site 0078
Contact
6463509159
Local Institution - 0055
Biala Podlaska , 21-50, Poland
Local Institution - 0062
Bydgoszcz , 85-79, Poland
Local Institution - 0083
Gdansk , 80-21, Poland
Local Institution - 0009
Gliwice , 44-10, Poland
Local Institution - 0021
Krakow , 30-68, Poland
Local Institution - 0098
Krakow , 31-11, Poland
Local Institution - 0001
Poznan , 60-56, Poland
Local Institution - 0023
Warszawa , 02-78, Poland
Local Institution - 0050
Coimbra , 3030-, Portugal
Local Institution - 0052
Lisboa , 1500-, Portugal
Local Institution - 0024
Bucuresti , 02223, Romania
Local Institution - 0002
Cluj-Napoca , 40013, Romania
Local Institution - 0040
Cluj-Napoca , 40046, Romania
Local Institution - 0016
Craiova , 20034, Romania
SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
Chelyabinsk , 45408, Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo , 15304, Russian Federation
Local Institution
Moscow , 11547, Russian Federation
Local Institution
Moscow , 11799, Russian Federation
Local Institution - 0015
Moscow , 12130, Russian Federation
Local Institution
Moscow , 12135, Russian Federation
Hertzen Moscow Oncology Research Center
Moscow , 12528, Russian Federation
Local Institution
Nizghiy Novgorod , 60300, Russian Federation
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
Omsk , 64401, Russian Federation
LLC Eurocityclinic
Saint Petersburg , 19702, Russian Federation
Local Institution - 0048
Barcelona , 08003, Spain
Local Institution - 0102
Barcelona , 08035, Spain
Local Institution - 0049
Barcelona , 08041, Spain
Local Institution - 0072
Madrid , 28026, Spain
Local Institution - 0067
Madrid , 28033, Spain
Local Institution - 0074
Madrid , 28046, Spain
Local Institution - 0075
Madrid , 28050, Spain
Local Institution - 0032
Sabadell , 08208, Spain
Local Institution - 0086
Santander , 39008, Spain
Local Institution - 0059
Sevilla , 31013, Spain
Local Institution
Adana , 1123, Turkey
Local Institution - 0026
Ankara , 06230, Turkey
Local Institution - 0097
Ankara , 06590, Turkey
Local Institution - 0019
Istanbul , 34098, Turkey
Local Institution - 0035
Istanbul , 34214, Turkey
Local Institution
Izmir , 111, Turkey

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

632

Study ID:

NCT04810078

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.