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Clinical Trials in Ireland / NCT04810078
Active, not recruiting Phase 3

A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread

NCT04810078 · tracked via the Priya Life Science Ireland tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2021-05-21
Last updated
2025-10-09

Condition(s) studied

Clear Cell Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

Nivolumab and rHuPH20Nivolumab

Nivolumab and rHuPH20: Specified dose on specified days

Nivolumab: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 * 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: 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 Other protocol-defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Trial sites (89)

FacilityCityRegionStatus
Local Institution Chicago Illinois
Local Institution - 0025 Buffalo New York
Local Institution - 0088 West Reading Pennsylvania
Local Institution - 0095 Capital Federal Buenos Aires
Local Institution - 0058 Mar del Plata Buenos Aires
Local Institution - 0037 Pergamino Buenos Aires
Local Institution - 0079 Parana Córdoba Province
Local Institution - 0030 Río Cuarto Córdoba Province
Local Institution - 0066 Viedma Río Negro Province
Local Institution - 0038 Buenos Aires Argentina
Local Institution - 0056 San Juan Argentina
Local Institution - 0064 Curitiba Paraná
Local Institution - 0107 Ijuí Rio Grande do Sul
Local Institution - 0039 Porto Alegre Rio Grande do Sul
Local Institution - 0071 Barretos São Paulo
Local Institution - 0070 São José do Rio Preto São Paulo
Local Institution - 0090 Rio de Janeiro Brazil
Local Institution - 0081 São Paulo Brazil
Local Institution - 0096 São Paulo Brazil
Local Institution - 0084 Temuco Araucania
Local Institution - 0005 Santiago Santiago Metropolitan
Local Institution - 0104 Santiago Santiago Metropolitan
Local Institution - 0076 Santiago Santiago Metropolitan
Local Institution - 0077 Viña del Mar Valparaiso
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
Local Institution - 0033 Cremona Italy
Local Institution - 0008 Florence Italy
Local Institution - 0027 Meldola Italy
Local Institution - 0018 Milan Italy
Local Institution Milan Italy

+ 49 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04810078 on ClinicalTrials.gov ↗ ← All trials in Ireland