A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy
Who is this study for? Patients with Clear Cell Renal Cell Carcinoma
What treatments are being studied? Nivolumab
Status: Active_not_recruiting
Location: See all (83) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
Local Institution
Chicago
New York
Local Institution - 0025
Buffalo
Pennsylvania
Local Institution - 0088
West Reading
Other Locations
Argentina
Local Institution - 0038
Buenos Aires
Local Institution - 0095
Capital Federal
Local Institution - 0058
Mar Del Plata
Local Institution - 0079
Parana
Local Institution - 0037
Pergamino
Local Institution - 0030
Río Cuarto
Local Institution - 0056
San Juan
Local Institution - 0066
Viedma
Brazil
Local Institution - 0071
Barretos
Local Institution - 0064
Curitiba
Local Institution - 0107
Ijuí
Local Institution - 0039
Porto Alegre
Local Institution - 0090
Rio De Janeiro
Local Institution - 0070
São José Do Rio Preto
Local Institution - 0081
São Paulo
Local Institution - 0096
São Paulo
Chile
Local Institution - 0005
Santiago
Local Institution - 0076
Santiago
Local Institution - 0104
Santiago
Local Institution - 0084
Temuco
Local Institution - 0077
Viña Del Mar
Finland
Local Institution - 0017
Tampere
France
Local Institution
Nice
Local Institution - 0051
Suresnes
Local Institution - 0068
Villejuif
Ireland
Local Institution - 0060
Tallaght
Italy
Local Institution - 0033
Cremona
Local Institution - 0008
Florence
Local Institution - 0027
Meldola
Local Institution
Milan
Local Institution - 0018
Milan
Local Institution - 0014
Padua
Local Institution - 0082
Parma
Local Institution - 0092
Pavia
Local Institution - 0100
Roma
Local Institution - 0091
Rome
Local Institution - 0057
Terni
Mexico
Local Institution - 0031
Monterrey
Local Institution - 0103
Monterrey
Local Institution - 0065
Querétaro
Local Institution - 0085
Querétaro
Local Institution - 0105
San Luis Potosí City
Local Institution - 0089
Tlalpan
Local Institution - 0101
Torreón
New Zealand
Local Institution - 0053
Auckland
Local Institution - 0041
Hamilton
Local Institution - 0078
Palmerston North
Poland
Local Institution - 0055
Biała Podlaska
Local Institution - 0062
Bydgoszcz
Local Institution - 0083
Gdansk
Local Institution - 0021
Krakow
Local Institution - 0098
Krakow
Local Institution - 0001
Poznan
Local Institution - 0023
Warsaw
Portugal
Local Institution - 0050
Coimbra
Local Institution - 0052
Lisbon
Romania
Local Institution - 0024
Bucharest
Local Institution - 0002
Cluj-napoca
Local Institution - 0040
Cluj-napoca
Local Institution - 0016
Craiova
Russian Federation
SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine
Chelyabinsk
Ivanovo Regional Oncology Dispensary
Ivanovo
Hertzen Moscow Oncology Research Center
Moscow
Local Institution
Nizghiy Novgorod
Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary