A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer

NCT03873402 · tracked via the Priya Life Science Italy tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2019-06-21

Last updated

2026-01-21

Condition(s) studied

Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

Nivolumab →Ipilimumab →Ipilimumab placebo

Nivolumab: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Ipilimumab placebo: Specified dose on specified days

Study summary

The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features. * Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC). * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria. * No prior systemic therapy for RCC * Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC). Exclusion Criteria: * Any active central nervous system (CNS) metastases. * Active, known, or suspected autoimmune disease. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other agents specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Progression free survival (PFS) by blinded independent central review (BICR) — Up to 34 months
Objective response rate (ORR) by BICR — Up to 23 months

Trial sites (78)

Facility	City	Region
Local Institution - 0013	Washington D.C.	District of Columbia
Local Institution - 0053	Athens	Georgia
Local Institution - 0066	Boston	Massachusetts
Local Institution - 0088	Boston	Massachusetts
Local Institution - 0086	Boston	Massachusetts
The Reading Hosp Med Ctr Reg Cancer Ctr	West Reading	Pennsylvania
Local Institution - 0084	Charleston	South Carolina
Local Institution - 0100	Capital Federal	Buenos Aires
Local Institution - 0011	Ciudad Autónoma de Buenos Aires	Buenos Aires
Local Institution - 0060	Mar del Plata	Buenos Aires
Local Institution - 0025	Río Cuarto	Córdoba Province
Local Institution - 0001	Viedma	Río Negro Province
Local Institution - 0005	Córdoba	Argentina
Local Institution - 0002	San Juan	Argentina
Local Institution - 0033	Graz	Austria
Local Institution - 0031	Vienna	Austria
Local Institution - 0032	Wels	Austria
Local Institution - 0017	Independencia	Santiago Metropolitan
Local Institution - 0003	Santiago	Santiago Metropolitan
Local Institution - 0034	Santiago	Santiago Metropolitan
Local Institution - 0004	Viña del Mar	Valparaiso
Local Institution - 0012	Viña El Mar	Valparaiso
Local Institution - 0020	Brno	South Moravian
Local Institution - 0097	Brno	Czechia
Local Institution - 0019	Prague	Czechia
Local Institution - 0018	Prague	Czechia
Local Institution - 0096	Nice	Alpes-Maritimes
Local Institution - 0074	Brest	Finistère
Local Institution - 0078	Nancy	Meurthe-et-Moselle
Local Institution - 0091	Valenciennes	Nord
Local Institution - 0073	Angers	France
Local Institution - 0069	Angers	France
Local Institution - 0075	Besançon	France
Local Institution - 0094	Caen	France
Local Institution - 0081	Hyères	France
Local Institution - 0080	La Tronche	France
Local Institution - 0071	Marseille	France
Local Institution - 0092	Paris	France
Local Institution - 0093	Strasbourg	France
Local Institution - 0072	Suresnes	France

+ 38 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

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Other trials for the same condition

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma Active, not recruiting

A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) Recruiting

Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma Recruiting

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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 NCT03873402 on ClinicalTrials.gov ↗ ← All trials in Italy