Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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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

Criterios de exclusión

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

Ubicaciones

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

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