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NCT04810078

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

681

Start Date

2021-05-21

Completion Date

2027-05-10

Last Updated

2025-10-09

Healthy Volunteers

Conditions

Clear Cell Renal Cell Carcinoma

Interventions

BIOLOGICAL

Nivolumab and rHuPH20

Specified dose on specified days

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 * 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

Locations (89)

Local Institution

Chicago, Illinois, United States

Local Institution - 0025

Buffalo, New York, United States

Local Institution - 0088

West Reading, Pennsylvania, United States

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

Local Institution - 0064

Curitiba, Paraná, Brazil

Local Institution - 0107

Ijuí, Rio Grande do Sul, Brazil

Local Institution - 0039

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0071

Barretos, São Paulo, Brazil

Local Institution - 0070

São José do Rio Preto, São Paulo, Brazil

Local Institution - 0090

Rio de Janeiro, Brazil

Local Institution - 0081

São Paulo, Brazil

Local Institution - 0096

São Paulo, Brazil

Local Institution - 0084

Temuco, Región de la Araucanía, Chile

Local Institution - 0077

Viña del Mar, Región de Valparaíso, Chile

Local Institution - 0005

Santiago, Santiago Metropolitan, Chile

Local Institution - 0104

Santiago, Santiago Metropolitan, Chile

Local Institution - 0076

Santiago, Santiago Metropolitan, Chile

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, Ireland

Local Institution - 0033

Cremona, Italy

Local Institution - 0008

Florence, Italy

Local Institution - 0027

Meldola, Italy

Local Institution - 0018

Milan, Italy

Local Institution

Milan, Italy

Local Institution - 0014

Padova, Italy

Local Institution - 0082

Parma, Italy

Local Institution - 0092

Pavia, Italy

Local Institution - 0100

Roma, Italy

Local Institution - 0091

Rome, Italy

Local Institution - 0057

Terni, Italy

Local Institution - 0101

Torreón, Coahuila, Mexico

Local Institution - 0089

Tlalpan, Mexico City, Mexico

Local Institution - 0103

Monterrey, Nuevo León, Mexico

Local Institution - 0031

Monterrey, Nuevo León, Mexico

Local Institution - 0065

Querétaro, Mexico

Local Institution - 0085

Querétaro, Mexico

Local Institution - 0105

San Luis Potosí City, Mexico

Local Institution - 0053

Auckland, New Zealand

Local Institution - 0041

Hamilton, New Zealand

Local Institution - 0078

Palmerston North, New Zealand

Local Institution - 0055

Biała Podlaska, Poland

Local Institution - 0062

Bydgoszcz, Poland

Local Institution - 0083

Gdansk, Poland

Local Institution - 0021

Krakow, Poland

Local Institution - 0098

Krakow, Poland

Local Institution - 0001

Poznan, Poland

Local Institution - 0023

Warsaw, Poland

Local Institution - 0050

Coimbra, Portugal

Local Institution - 0052

Lisbon, Portugal

Local Institution - 0024

Bucharest, Romania

Local Institution - 0002

Cluj-Napoca, Romania

Local Institution - 0040

Cluj-Napoca, Romania

Local Institution - 0016

Craiova, Romania

SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

Chelyabinsk, Russia

Ivanovo Regional Oncology Dispensary

Ivanovo, Russia

Hertzen Moscow Oncology Research Center

Moscow, Russia

Local Institution

Nizghiy Novgorod, Russia

Budgetary Healthcare Institution of Omsk Region - Clinical Oncological Dispensary

Omsk, Russia

LLC Eurocityclinic

Saint Petersburg, Russia

Local Institution - 0048

Barcelona, Spain

Local Institution - 0102

Barcelona, Spain

Local Institution - 0049

Barcelona, Spain

Local Institution - 0072

Madrid, Spain

Local Institution - 0067

Madrid, Spain

Local Institution - 0074

Madrid, Spain

Local Institution - 0075

Madrid, Spain

Local Institution - 0032

Sabadell, Spain

Local Institution - 0086

Santander, Spain

Local Institution - 0059

Seville, Spain

Local Institution - 0035

Istanbul, Bagcilar, Turkey (Türkiye)

Local Institution - 0026

Ankara, Turkey (Türkiye)

Local Institution - 0097

Ankara, Turkey (Türkiye)

Local Institution - 0019

Istanbul, Turkey (Türkiye)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (89)