A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
NCT ID: NCT04810078
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
681 participants
INTERVENTIONAL
2021-05-21
2027-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Nivolumab and rHuPH20
Specified dose on specified days
Arm B
Nivolumab
Specified dose on specified days
Arm C
Nivolumab and rHuPH20
Specified dose on specified days
Arm D
Nivolumab and rHuPH20
Specified dose on specified days
Interventions
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Nivolumab and rHuPH20
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Chicago, Illinois, United States
Local Institution - 0025
Buffalo, New York, United States
Local Institution - 0088
West Reading, Pennsylvania, United States
Local Institution - 0095
Capital Federal, Buenos Aires, Argentina
Local Institution - 0058
Mar del Plata, Buenos Aires, Argentina
Local Institution - 0037
Pergamino, Buenos Aires, Argentina
Local Institution - 0079
Parana, Córdoba Province, Argentina
Local Institution - 0030
Río Cuarto, Córdoba Province, Argentina
Local Institution - 0066
Viedma, Río Negro Province, Argentina
Local Institution - 0038
Buenos Aires, , Argentina
Local Institution - 0056
San Juan, , Argentina
Local Institution - 0064
Curitiba, Paraná, Brazil
Local Institution - 0107
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 0039
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0071
Barretos, São Paulo, Brazil
Local Institution - 0070
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0090
Rio de Janeiro, , Brazil
Local Institution - 0081
São Paulo, , Brazil
Local Institution - 0096
São Paulo, , Brazil
Local Institution - 0084
Temuco, Región de la Araucanía, Chile
Local Institution - 0077
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0005
Santiago, Santiago Metropolitan, Chile
Local Institution - 0104
Santiago, Santiago Metropolitan, Chile
Local Institution - 0076
Santiago, Santiago Metropolitan, Chile
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, Ireland
Local Institution - 0033
Cremona, , Italy
Local Institution - 0008
Florence, , Italy
Local Institution - 0027
Meldola, , Italy
Local Institution - 0018
Milan, , Italy
Local Institution
Milan, , Italy
Local Institution - 0014
Padua, , Italy
Local Institution - 0082
Parma, , Italy
Local Institution - 0092
Pavia, , Italy
Local Institution - 0100
Roma, , Italy
Local Institution - 0091
Rome, , Italy
Local Institution - 0057
Terni, , Italy
Local Institution - 0101
Torreón, Coahuila, Mexico
Local Institution - 0089
Tlalpan, Mexico City, Mexico
Local Institution - 0103
Monterrey, Nuevo León, Mexico
Local Institution - 0031
Monterrey, Nuevo León, Mexico
Local Institution - 0065
Querétaro, , Mexico
Local Institution - 0085
Querétaro, , Mexico
Local Institution - 0105
San Luis Potosí City, , Mexico
Local Institution - 0053
Auckland, , New Zealand
Local Institution - 0041
Hamilton, , New Zealand
Local Institution - 0078
Palmerston North, , New Zealand
Local Institution - 0055
Biała Podlaska, , Poland
Local Institution - 0062
Bydgoszcz, , Poland
Local Institution - 0083
Gdansk, , Poland
Local Institution - 0021
Krakow, , Poland
Local Institution - 0098
Krakow, , Poland
Local Institution - 0001
Poznan, , Poland
Local Institution - 0023
Warsaw, , Poland
Local Institution - 0050
Coimbra, , Portugal
Local Institution - 0052
Lisbon, , Portugal
Local Institution - 0024
Bucharest, , Romania
Local Institution - 0002
Cluj-Napoca, , Romania
Local Institution - 0040
Cluj-Napoca, , Romania
Local Institution - 0016
Craiova, , Romania
SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
Chelyabinsk, , Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, , Russia
Hertzen Moscow Oncology Research Center
Moscow, , Russia
Local Institution
Nizghiy Novgorod, , Russia
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
Omsk, , Russia
LLC Eurocityclinic
Saint Petersburg, , Russia
Local Institution - 0048
Barcelona, , Spain
Local Institution - 0102
Barcelona, , Spain
Local Institution - 0049
Barcelona, , Spain
Local Institution - 0072
Madrid, , Spain
Local Institution - 0067
Madrid, , Spain
Local Institution - 0074
Madrid, , Spain
Local Institution - 0075
Madrid, , Spain
Local Institution - 0032
Sabadell, , Spain
Local Institution - 0086
Santander, , Spain
Local Institution - 0059
Seville, , Spain
Local Institution - 0035
Istanbul, Bagcilar, Turkey (Türkiye)
Local Institution - 0026
Ankara, , Turkey (Türkiye)
Local Institution - 0097
Ankara, , Turkey (Türkiye)
Local Institution - 0019
Istanbul, , Turkey (Türkiye)
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-003655-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1255-9514
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA209-67T
Identifier Type: -
Identifier Source: org_study_id
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