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Clinical Trials in the USA / NCT03873402
Active, not recruiting Phase 3

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

NCT03873402 · tracked via the Priya Life Science USA 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
No
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)

FacilityCityRegionStatus
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

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A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors Active, not 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 the USA