NCT04810078
Recruiting
March 22, 2021
April 15, 2022
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 renal cell carcinoma that is advanced or has spread.
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Arm A: Subcutaneous Nivolumab |
Biological: Nivolumab and rHuPH20 Specified dose on specified days |
Active Comparator: Arm B: Intravenous Nivolumab |
Biological: Nivolumab Specified dose on specified days |
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 on the study 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
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Illinois
Local Institution
Chicago
United States, New York
Roswell Park Cancer Institute
Buffalo
United States, Pennsylvania
Reading Hospital McGlinn Cancer Institute
West Reading
Argentina, Buenos Aires
Local Institution - 0058
Mar Del Plata
Argentina, Buenos Aires
Centro de Investigacion Pergamino S.A.
Pergamino
Argentina, Cordoba
Local Institution - 0030
Rio Cuarto
Argentina, RIO Negro
Centro de Investigaciones Clinicas. Clinica Viedma S.A.
Viedma
Argentina
Local Institution - 0038
Buenos Aires
Argentina
Local Institution - 0095
Buenos Aires
Argentina
Instituto Oncologico de Cordoba IONC
Cordoba
Argentina
CER San Juan
San Juan
Brazil, Parana
Instituto de Oncologia do Parana (IOP)
Curitiba
Brazil, RIO Grande DO SUL
Local Institution
Ijui
Brazil, RIO Grande DO SUL
Local Institution
Ijui
Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre
Brazil, SAO Paulo
Local Institution
Barretos
Brazil, SAO Paulo
Local Institution
Sao Jose Do Rio Preto
Brazil
Local Institution
Rio de Janeiro
Brazil
Local Institution
Sao Paulo
Brazil
Local Institution
Sao Paulo
Chile, Araucania
Local Institution - 0084
Temuco
Chile, Metropolitana
Local Institution - 0005
Santiago de Chile
Chile, Metropolitana
Local Institution - 0104
Santiago de Chile
Chile, Metropolitana
Local Institution - 0076
Santiago
Chile, Valparaiso
Oncocentro Apys
Vina del Mar
Czechia
Local Institution - 0063
Brno
Czechia
Local Institution - 0036
Hradec Kralove
Czechia
Local Institution - 0020
Olomouc
Czechia
Fakultni nemocnice Ostrava
Ostrava
Czechia
Thomayerova nemocnice
Prague
Czechia
Fakultna nemocnice Bulovka
Praha
Finland
Local Institution
Jyvaskyla
Finland
Local Institution
Kuopio
Finland
Tampere University Hospital
Tampere
Finland
Local Institution
Turku
France
Local Institution
Lyon
France
Local Institution
Nice cedex 2
France
Local Institution
Suresnes
France
Local Institution
Toulouse
France
Local Institution
Villejuif
Ireland
Local Institution
Cork
Ireland
Local Institution
Dublin
Ireland
Tallaght University Hospital
Dublin
Italy
ASST Istituti Ospitalieri, Oncology Department
Cremona
Italy
AOU Careggi
Firenze
Italy
Local Institution - 0027
Meldola
Italy
Local Institution
Milano
Italy
Local Institution - 0018
Milano
Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padova
Italy
Local Institution
Parma
Italy
Local Institution
Pavia
Italy
Local Institution
Pisa
Italy
Local Institution
Roma
Italy
Local Institution
Rome
Italy
Azienda Ospedaliera A S.Maria
Terni
Mexico, Coahuila
Local Institution - 0101
Torreon
Mexico, Distrito Federal
Local Institution - 0089
Tlalpan
Mexico, Nuevo LEON
Local Institution
Monterrey
Mexico, Nuevo LEON
Local Institution - 0031
Monterrey
Mexico
Local Institution
Queretaro
Mexico
Local Institution - 0085
Queretaro
Mexico
Local Institution - 0105
San Luis Potosi
New Zealand
Local Institution - 0053
Auckland
New Zealand
Local Institution - 0041
Hamilton
New Zealand
Local Institution
Palmerston North
Poland
Wojewadzki Szpital Specjalistyczny w Biaej Podlaskiej SMO KO-MED CENTRA KLINICZNE SP. Z O.O.
Biala Podlaska
Poland
Local Institution - 0062
Bydgoszcz
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk
Poland
Local Institution
Gliwice
Poland
Local Institution - 0021
Krakow
Poland
Local Institution
Krakow
Poland
Local Institution - 0001
Poznan
Poland
Local Institution - 0023
Warszawa
Portugal
Instituto Portugues de Oncologia de Coimbra Francisco Gentil EPE
Coimbra
Portugal
Hospital da Luz
Lisboa
Romania
Local Institution
Bucuresti
Romania
Local Institution
Cluj-Napoca
Romania
Local Institution
Cluj-Napoca
Romania
Local Institution
Craiova
Russian Federation
SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
Chelyabinsk
Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo
Russian Federation
Local Institution
Moscow
Russian Federation
Local Institution
Moscow
Russian Federation
Local Institution
Moscow
Russian Federation
Local Institution
Moscow
Russian Federation
Hertzen Moscow Oncology Research Center
Moscow
Russian Federation
Local Institution
Nizghiy Novgorod
Russian Federation
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary
Omsk
Russian Federation
LLC Eurocityclinic
Saint Petersburg
Spain
Local Institution
Barcelona
Spain
Local Institution
Barcelona
Spain
Hospital Del Mar
Barcelona
Spain
Local Institution - 0072
Madrid
Spain
MD Anderson Cancer Center Madrid
Madrid
Spain
Local Institution - 0074
Madrid
Spain
HM Universitario Sanchinarro - CIOCC
Madrid
Spain
Local Institution
Sabadell
Spain
Hospital Marques de Valdecilla
Santander
Spain
Local Institution - 0059
Sevilla
Turkey
Local Institution
Adana
Turkey
Local Institution
Ankara
Turkey
Local Institution
Ankara
Turkey
Local Institution
Istanbul
Turkey
Local Institution
Istanbul
Turkey
Local Institution
Izmir
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb