Clinical trial • Phase III • Oncology

NIVOLUMAB for Advanced renal cell carcinoma

Phase III trial of NIVOLUMAB for Advanced renal cell carcinoma.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced renal cell carcinoma
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
15-12-2023
First CTIS Authorization Date
30-01-2024

Trial design

Randomised, nivolumab combined with ipilimumab versus nivolumab and placebo (placebo: 5% dextrose or sodium chloride solution as listed).-controlled Phase III trial in Austria, Czechia, Greece and others.

Randomised
Yes
Comparator
Nivolumab combined with Ipilimumab versus Nivolumab and placebo (placebo: 5% Dextrose or Sodium chloride solution as listed).
Target Sample Size
194

Eligibility

Recruits 194 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms (L1 documents) are present for multiple Member States (see document listings per country). No explicit wording on assent or parental consent for minors was found in the available data..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information sheets and informed consent forms (L1 documents) are present for multiple Member States (see document listings per country). No explicit wording on assent or parental consent for minors was found in the available data.

Inclusion criteria

  • {"criterion_text":"- Histological confirmation of renal carcinoma with clear cell component including participants who may have sarcomatoid features.\n- Advanced (not amenable to curative surgery or radiation therapy) renal cell carcinoma (RCC) or metastatic RCC (mRCC).\n- Measurable disease by CT or MRI per RECIST 1.1 criteria.\n- No prior systemic therapy for RCC\n- Must be intermediate or poor risk as per International Metastatic RCC Database Consortium (IMDC)."}

Exclusion criteria

  • {"criterion_text":"- Any active central nervous system (CNS) metastases.\n- Active, known, or suspected autoimmune disease\n- 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"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression free survival (PFS) by BICR","definition_or_measurement_approach":"PFS assessed by Blinded Independent Central Review (BICR); main objectives reference RECIST 1.1 for assessment."}
  • {"endpoint_text":"- Overall Response Rate (ORR) by BICR","definition_or_measurement_approach":"ORR assessed by Blinded Independent Central Review (BICR) using RECIST 1.1 as indicated in main objectives."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"OS (as listed); no further measurement definition provided in the available data."}
  • {"endpoint_text":"- Overall response rate (ORR) by Investigator","definition_or_measurement_approach":"ORR assessed by Investigator (per endpoint text)."}
  • {"endpoint_text":"- Disease control rate (DCR) by Investigator and by blinded independent central review (BICR)","definition_or_measurement_approach":"DCR assessed by Investigator and by BICR (per endpoint text)."}
  • {"endpoint_text":"- Duration of response (DoR) by Investigator and by blinded independent central review (BICR)","definition_or_measurement_approach":"DoR assessed by Investigator and by BICR (per endpoint text)."}
  • {"endpoint_text":"- Time to objective response (TTR) by Investigator and by blinded independent central review (BICR)","definition_or_measurement_approach":"TTR assessed by Investigator and by BICR (per endpoint text)."}
  • {"endpoint_text":"- Progression free survival (PFS) and PFS2 per Investigator","definition_or_measurement_approach":"PFS and PFS2 assessed by Investigator (per endpoint text)."}
  • {"endpoint_text":"- Incidence of adverse events (AEs), Serious Adverse Events, drug - related SAEs and significant changes in laboratory tests (Hematology tests, Coagulation tests), Clinical Chemistry Tests and Serology Tests)","definition_or_measurement_approach":"Safety endpoints based on incidence/reporting of AEs, SAEs, drug-related SAEs and significant laboratory changes (per endpoint text)."}
  • {"endpoint_text":"- PFS, ORR and OS based on GEP signatures","definition_or_measurement_approach":"Efficacy endpoints (PFS, ORR, OS) evaluated by gene expression profile (GEP) signatures (per endpoint text)."}
  • {"endpoint_text":"- Overall Survival based on programmed cell death protein ligand-1 (PD-L1) expression","definition_or_measurement_approach":"OS stratified/analysed by PD-L1 expression (per endpoint text)."}
  • {"endpoint_text":"- Overall response rate (ORR) by BICR based on PD-L1 expression","definition_or_measurement_approach":"ORR by BICR analysed by PD-L1 expression (per endpoint text)."}
  • {"endpoint_text":"- Progression Free Survival (PFS) by BICR based on PD-L1 expression)","definition_or_measurement_approach":"PFS by BICR analysed by PD-L1 expression (per endpoint text)."}

Recruitment

Planned Sample Size
194
Recruitment Window Months
92
Consent Approach
Subject information sheets and informed consent forms (L1 documents) are provided per Member State (document titles indicate availability in Czech, Greek, Italian, Romanian, Spanish, French, Polish and English). Consent is provided by adult participants (documents labelled 'Main adult' exist); no explicit assent or parental consent text for minors was found in the available records.

Geography

Total Number Of Sites
44
Total Number Of Participants
194

Austria

Latest Decision Or Authorization Date
02-03-2026
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Medical University Of Graz
Department Name
University clinic for Internal Medicine (UKIM)
Principal Investigator Name
Thomas Bauernhofer
Principal Investigator Email
thomas.bauernhofer@medunigraz.at
Contact Person Name
Thomas Bauernhofer
Site Name
Medical University of Vienna
Department Name
Internal Medicine I - Department for Oncology
Principal Investigator Name
Manuela Schmidinger
Principal Investigator Email
manuela.schmidinger@meduniwien.ac.at
Contact Person Name
Manuela Schmidinger

Czechia

Latest Decision Or Authorization Date
02-03-2026
Number Of Sites
3
Number Of Participants
21

Sites

Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexni onkologicke pece
Principal Investigator Name
Alexandr Poprach
Principal Investigator Email
poprach@mou.cz
Contact Person Name
Alexandr Poprach
Contact Person Email
poprach@mou.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Onkologicka klinika
Principal Investigator Name
Jan Dvorak
Principal Investigator Email
jan.dvorak@fnkv.cz
Contact Person Name
Jan Dvorak
Contact Person Email
jan.dvorak@fnkv.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologicka klinika1. LF UK a FTN
Principal Investigator Name
Tomas Buchler
Principal Investigator Email
tomas.buchler@ftn.cz
Contact Person Name
Tomas Buchler
Contact Person Email
tomas.buchler@ftn.cz

Greece

Latest Decision Or Authorization Date
02-03-2026
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
General University Hospital Of Larissa
Department Name
Department of Medical Oncology
Principal Investigator Name
Athanasios Kotsakis
Principal Investigator Email
thankotsakis@hotmail.com
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com
Site Name
Athens Medical Center S.A.
Department Name
Department of Medical Oncology
Principal Investigator Name
Marinos Tsiatas
Principal Investigator Email
mtsiatas@otenet.gr
Contact Person Name
Marinos Tsiatas
Contact Person Email
mtsiatas@otenet.gr

Italy

Latest Decision Or Authorization Date
08-04-2026
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Azienda USL Toscana Sud Est
Department Name
Oncology
Principal Investigator Name
Alketa Hamzaj
Principal Investigator Email
alketa.hamzaj@uslsudest.toscana.it
Contact Person Name
Alketa Hamzaj
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Oncology
Principal Investigator Name
Sebastiano Buti
Principal Investigator Email
sebabuti@libero.it
Contact Person Name
Sebastiano Buti
Contact Person Email
sebabuti@libero.it
Site Name
European Institute Of Oncology S.r.l.
Department Name
Oncology
Principal Investigator Name
Franco Nolè
Principal Investigator Email
franco.nole@ieo.it
Contact Person Name
Franco Nolè
Contact Person Email
franco.nole@ieo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Oncology Division
Principal Investigator Name
Francesca Valcamonico
Principal Investigator Email
franzval@yahoo.it
Contact Person Name
Francesca Valcamonico
Contact Person Email
franzval@yahoo.it

Romania

Latest Decision Or Authorization Date
14-04-2026
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Oncologie
Principal Investigator Name
Tudor Ciuleanu
Principal Investigator Email
tudor_ciuleanu@hotmail.com
Contact Person Name
Tudor Ciuleanu
Contact Person Email
tudor_ciuleanu@hotmail.com
Site Name
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti
Department Name
Oncologie
Principal Investigator Name
Aurelia Alexandru
Principal Investigator Email
auralexandru@yahoo.com
Contact Person Name
Aurelia Alexandru
Contact Person Email
auralexandru@yahoo.com
Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Oncologie
Principal Investigator Name
Michael Schenker
Principal Investigator Email
mike_schenker@yahoo.com
Contact Person Name
Michael Schenker
Contact Person Email
mike_schenker@yahoo.com

Spain

Latest Decision Or Authorization Date
03-03-2026
Number Of Sites
10
Number Of Participants
50

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Principal Investigator Name
Ignacio Duran Martinez
Principal Investigator Email
XXXXX@XXX.com
Contact Person Name
Ignacio Duran Martinez
Contact Person Email
XXXXX@XXX.com
Site Name
Vall D'hebron Institut De Recerca
Department Name
Oncology-Genitourinary
Principal Investigator Name
Cristina Suarez Rodriguez
Principal Investigator Email
csuarez@vhio.net
Contact Person Name
Cristina Suarez Rodriguez
Contact Person Email
csuarez@vhio.net
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
MEDICAL ONCOLOGY
Principal Investigator Name
Miguel Climent Duran
Principal Investigator Email
macliment@fivo.org
Contact Person Name
Miguel Climent Duran
Contact Person Email
macliment@fivo.org
Site Name
Hospital General Universitario Reina Sofia
Department Name
Oncology
Principal Investigator Name
Maria Jose Mendez Vidal
Principal Investigator Email
xxxxx@xxx.es
Contact Person Name
Maria Jose Mendez Vidal
Contact Person Email
xxxxx@xxx.es
Site Name
MD Anderson Cancer Center
Department Name
Oncology
Principal Investigator Name
Enrique Grande Pulido
Principal Investigator Email
egrande@mdanderson.es
Contact Person Name
Enrique Grande Pulido
Contact Person Email
egrande@mdanderson.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Oncology
Principal Investigator Name
Urbano Anido
Principal Investigator Email
urbano.anido.herranz@sergas.es
Contact Person Name
Urbano Anido
Contact Person Email
urbano.anido.herranz@sergas.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
MEDICAL ONCOLOGY
Principal Investigator Name
Begoña Valderrama
Principal Investigator Email
xxxxxx@xxx.com
Contact Person Name
Begoña Valderrama
Contact Person Email
xxxxxx@xxx.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Oncology
Principal Investigator Name
Enrique Gallardo Diaz
Principal Investigator Email
egallardo@tauli.cat
Contact Person Name
Enrique Gallardo Diaz
Contact Person Email
egallardo@tauli.cat
Site Name
Hospital Del Mar
Department Name
ONCOLOGY
Principal Investigator Name
Alejo Rodríguez-Vida Rodríguez
Principal Investigator Email
arodriguezvida@parcdesalutmar.cat
Contact Person Name
Alejo Rodríguez-Vida Rodríguez
Site Name
Universidad De Navarra
Department Name
MEDICAL ONCOLOGY
Principal Investigator Name
Nuria Lainez Milagro
Principal Investigator Email
nuria.lainez.milagro@navarra.es
Contact Person Name
Nuria Lainez Milagro

France

Latest Decision Or Authorization Date
20-04-2026
Number Of Sites
15
Number Of Participants
83

Sites

Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Institut de Cancérologie de Strasbourg
Principal Investigator Name
Philippe Barthélémy
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe Barthélémy
Contact Person Email
p.barthelemy@icans.eu
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Oncologie Médicale
Principal Investigator Name
Mathieu Laramas
Principal Investigator Email
mlaramas@chu-grenoble.fr
Contact Person Name
Mathieu Laramas
Contact Person Email
mlaramas@chu-grenoble.fr
Site Name
Institut Gustave Roussy
Department Name
Oncologie médicale
Principal Investigator Name
Laurence Albigès
Principal Investigator Email
laurence.albiges@gustaveroussy.fr
Contact Person Name
Laurence Albigès
Site Name
Institut Paoli-Calmettes
Department Name
Oncologie médicale
Principal Investigator Name
Gwenaelle Gravis
Principal Investigator Email
gravisg@ipc.unicancer.fr
Contact Person Name
Gwenaelle Gravis
Contact Person Email
gravisg@ipc.unicancer.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Urologie
Principal Investigator Name
Pierre Bigot
Principal Investigator Email
pibigot@chu-angers.fr
Contact Person Name
Pierre Bigot
Contact Person Email
pibigot@chu-angers.fr
Site Name
Centre Antoine Lacassagne
Department Name
Centre Antoine Lacassagne
Principal Investigator Name
Delpine Borchiellini
Principal Investigator Email
delphine.borchiellini@nice.unicancer.fr
Contact Person Name
Delpine Borchiellini
Site Name
Centre Francois Baclesse
Department Name
Centre François Baclesse
Principal Investigator Name
Florence Joly
Principal Investigator Email
f.joly@baclesse.unicancer.fr
Contact Person Name
Florence Joly
Contact Person Email
f.joly@baclesse.unicancer.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Institut de Cancérologie de l’Ouest
Principal Investigator Name
Frédéric Rolland
Principal Investigator Email
frederic.rolland@ico.unicancer.fr
Contact Person Name
Frédéric Rolland
Site Name
Hopital Prive Toulon Hyeres Sainte Marguerite
Department Name
Hôpital Privé Toulon Hyeres
Principal Investigator Name
Philippe Bernard
Principal Investigator Email
philippe.bernard@dartybox.com
Contact Person Name
Philippe Bernard
Contact Person Email
philippe.bernard@dartybox.com
Site Name
Besancon University Hospital Center
Department Name
Oncologie Médicale
Principal Investigator Name
Hamadi Almotlak
Principal Investigator Email
halmotlak@gmail.com
Contact Person Name
Hamadi Almotlak
Contact Person Email
halmotlak@gmail.com
Site Name
Nouvelle Clinique Des Dentellieres
Department Name
Centre Les Dentellières
Principal Investigator Name
Jessica Grosjean
Principal Investigator Email
grosjean@lesdentellieres.com
Contact Person Name
Jessica Grosjean
Contact Person Email
grosjean@lesdentellieres.com
Site Name
Medipole De Nancy
Department Name
Centre d'Oncologie de Gentilly
Principal Investigator Name
Raafet Affi
Principal Investigator Email
r.affi@ilcgroupe.fr
Contact Person Name
Raafet Affi
Contact Person Email
r.affi@ilcgroupe.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Oncologie
Principal Investigator Name
Emmanuelle Renaud
Principal Investigator Email
emmanuelle.renaud@chu-brest.fr
Contact Person Name
Emmanuelle Renaud
Contact Person Email
emmanuelle.renaud@chu-brest.fr
Site Name
Hospital Foch
Department Name
Urologie
Principal Investigator Name
Thierry Lebret
Principal Investigator Email
t.lebret@hopital-foch.org
Contact Person Name
Thierry Lebret
Contact Person Email
t.lebret@hopital-foch.org
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Oncologie Médicale
Principal Investigator Name
Philippe Barthélémy
Principal Investigator Email
p.barthelemy@icans.eu
Contact Person Name
Philippe Barthélémy
Contact Person Email
p.barthelemy@icans.eu

Poland

Latest Decision Or Authorization Date
21-04-2026
Number Of Sites
5
Number Of Participants
60

Sites

Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Principal Investigator Name
Joanna Wojcik-Tomaszewska
Principal Investigator Email
jwojcik@wco.gda.pl
Contact Person Name
Joanna Wojcik-Tomaszewska
Contact Person Email
jwojcik@wco.gda.pl
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Principal Investigator Name
Bogdan Żurawski
Principal Investigator Email
zurawskib@co.bydgoszcz.pl
Contact Person Name
Bogdan Żurawski
Contact Person Email
zurawskib@co.bydgoszcz.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Kilinka Nowotworów Układu Moczowego
Principal Investigator Name
Paweł Wiechno
Principal Investigator Email
wiechno@coi.pl
Contact Person Name
Paweł Wiechno
Contact Person Email
wiechno@coi.pl
Site Name
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Principal Investigator Name
Piotr Centkowski
Principal Investigator Email
piotr.centkowski@szpitalbp.pl
Contact Person Name
Piotr Centkowski
Contact Person Email
piotr.centkowski@szpitalbp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Klinika Onkologii, Oddział Chemioterapii
Principal Investigator Name
Piotr Tomczak
Principal Investigator Email
md.piotr.tomczak@gmail.com
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com

Sponsor

Primary sponsor

Full Name
Bristol-Myers Squibb Services Unlimited Company
Organisation Type
Pharmaceutical company
Country Of Registered Address
Ireland

Contract research organisations

Name
Signant Health Global LLC
Responsibilities
Subject Number assignment, Treatment/Arm assignment,Drug (re)supplies assignment, IVRS30 – treatment randomisation
Name
Accenture Solutions Private Limited
Responsibilities
Pharmacovigilance duties: Medical review and Cases Data Entry; Embarc operations (multiple entries)
Name
Greenphire LLC
Responsibilities
Provides electronic payments, travel arrangements,electronic study-related comunications to patients
Name
Icon Laboratory Services Inc.
Responsibilities
Data entry of Local Laboratory Values

Third parties

  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Subject Number assignment, Treatment/Arm assignment,Drug (re)supplies assignment, IVRS30 – treatment randomisation","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"(no duty description provided for this entry)","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Data entry of Local Laboratory Values","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/15/1014/002)
Maximum Dose
480 mg (max daily dose amount as listed)
Investigational Product Name
Ipilimumab
Active Substance
IPILIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous
Route
Intravenous
Maximum Dose
1 mg/kg (max daily), 4 mg/kg (max total) as listed
Combination Treatment
Yes

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