NCT03873402Active, not recruitingPhase 3
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 437 (actual)
- First submitted
- 11 Mar 2019
- Start date
- 21 Jun 2019
- Primary completion date
- 11 Mar 2027
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Kidney cancer
- NCT number
- NCT03873402
- EU CT number
- 2023-508264-29-00
- EudraCT number
- 2018-004695-35
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 437
- From 21 Jun 2019 to the primary completion date, 11 Mar 2027
- 72 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Active, known, or suspected autoimmune disease.
Other
- Any active central nervous system (CNS) metastases.
Who the study is looking for
- 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).
Criteria the registry did not label
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (72)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Capital Federal | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Ciudad Autónoma de Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Río Cuarto | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | San Juan | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Viedma | Argentina | Unknown status |
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Active, not recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Independencia | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| - Coordinator of this site? Confirm its status | Viña El Mar | Chile | Unknown status |
| Masarykuv Onkologicky Ustav Coordinator of this site? Confirm its status | Brno-Stred | Czechia | Active, not recruiting |
| Fakultní Nemocnice Královské Vinohrady Coordinator of this site? Confirm its status | Prague 10 | Czechia | Active, not recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague 4 | Czechia | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Vall D'hebron Institut De Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital General Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Universidad de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Active, not recruiting |
| Besancon University Hospital Center Coordinator of this site? Confirm its status | Besancon Cedex | France | Active, not recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Active, not recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Active, not recruiting |
| Hopital Prive Toulon Hyeres Sainte Marguerite Coordinator of this site? Confirm its status | Hyères | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Medipole De Nancy Coordinator of this site? Confirm its status | Nancy | France | Active, not recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Active, not recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | St Herblain | France | Active, not recruiting |
| Institut de Cancérologie Strasbourg Europe Coordinator of this site? Confirm its status | Strasbourg | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Active, not recruiting |
| Nouvelle Clinique Des Dentellières Coordinator of this site? Confirm its status | Valenciennes | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Active, not recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Active, not recruiting |
| Azienda USL Toscana Sud Est Coordinator of this site? Confirm its status | Arezzo | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Parma Coordinator of this site? Confirm its status | Parma | Italy | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| - Coordinator of this site? Confirm its status | Querétaro | Mexico | Unknown status |
| Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Coordinator of this site? Confirm its status | Biala Podlaska | Poland | Active, not recruiting |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Active, not recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| The Reading Hosp Med Ctr Reg Cancer Ctr Coordinator of this site? Confirm its status | West Reading | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.