A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

CompletadoFase 3ClinicalTrials.gov

ID: NCT03138512Tipo: INTERVENTIONALInicio: 7 de jul de 2017Fin estimado: 1 de feb de 2024

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

Descripción detallada

The study has two primary endpoints. The first primary completion date is anticipated to be reached July 2022 (DFS in Part A). The second primary completion date is anticipated to be reached July 2024 (DFS in Part B).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have no clinical or radiological evidence of macroscopic residual disease or distant metastases after nephrectomy
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
Kidney tumor has been completely resected with negative surgical margins obtained. The randomization must occur greater than 4 weeks and less than (or equal to) 12 weeks from the date of nephrectomy
Pathologic tumor, node, and metastasis (TNM) staging meeting one of the following: pT2a, G3 or G4, N0 M0; pT2b, G any, N0 M0; pT3, (a, b, c), G any, N0 M0; pT4, G any, N0 M0; pT any, G any, N1 M0
Post-nephrectomy tumor shows renal cell cancer (RCC) with a predominantly clear cell histology, including participants with sarcomatoid features
Women must agree to follow methods of contraception, if applicable

Criterios de exclusión

Participants with an active known or suspected autoimmune disease
Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Any severe or serious, acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
History of allergy or hypersensitivity to study drug components
Participants with a condition requiring systemic treatment with corticosteroids
Participants who have received a live/attenuated vaccine within 30 days of first treatment

Intervenciones

biological

nivolumab

Specified dose on specified days

biological

ipilimumab

Specified dose on specified days

drug

nivolumab placebo

Specified dose on specified days

drug

ipilimumab placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0178

Capital Federal, Buenos Aires, Argentina

Local Institution - 0126

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0203

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0095

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0208

Mar del Plata, Buenos Aires, Argentina

Local Institution - 0173

Río Cuarto, Córdoba Province, Argentina

Local Institution - 0232

Bariloche, Río Negro Province, Argentina

Local Institution - 0179

Buenos Aires, Argentina

Local Institution - 0099

CABA, Argentina

Local Institution - 0096

Córdoba, Argentina

Local Institution - 0098

Córdoba, Argentina

Local Institution - 0164

San Juan, Argentina

Local Institution - 0097

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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