Last updated 45 days ago
A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
632 patients around the world
Available in Argentina
Bristol-Myers Squibb
7Research sites
632Patients around the world
This study is for people with
Kidney cancer
Clear Cell Renal Cell Carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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: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.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
Recruiting
Hospital Asociación de Beneficencia Hospital Sirio Libanes - CABA, Buenos Aires
Recruiting
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Centro Privado de RMI Río Cuarto
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Instituto de Nefrología Pergamino SRL
Recruiting
StudyCheckMate-67T
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Clear Cell Renal Cell CarcinomaKidney cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04810078
