Clinical trial • Phase III • Oncology
cabozantinib for Metastatic renal cell carcinoma
Phase III trial of cabozantinib for Metastatic renal cell carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Metastatic renal cell carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 16-09-2024
- First CTIS Authorization Date
- 14-10-2024
Trial design
Randomised, control arm: nivolumab + ipilimumab (nivolumab: dose unit mg/kg, maxdailydoseamount 3 mg/kg iv; ipilimumab: dose unit mg/kg, maxdailydoseamount 1 mg/kg iv). experimental arm: cabozantinib (cabometyx 20 mg film-coated tablets; dose unit mg, maxdailydoseamount 40 mg oral) in combination with nivolumab and ipilimumab. Phase III trial across 47 sites in Belgium, Czechia, Finland and others.
- Randomised
- Yes
- Comparator
- Control arm: Nivolumab + Ipilimumab (Nivolumab: dose unit mg/kg, maxDailyDoseAmount 3 mg/kg IV; Ipilimumab: dose unit mg/kg, maxDailyDoseAmount 1 mg/kg IV). Experimental arm: Cabozantinib (CABOMETYX 20 mg film-coated tablets; dose unit mg, maxDailyDoseAmount 40 mg oral) in combination with Nivolumab and Ipilimumab.
- Target Sample Size
- 517
Eligibility
Recruits 517 adults.
Inclusion criteria
- {"criterion_text":"- 1. Histologically confirmed advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.\n- 2. Intermediate- or poor-risk RCC as defined by International Metastatic RCC Database Consortium (IMDC) criteria.\n- 3. Measurable disease per RECIST 1.1 as determined by the Investigator.\n- 4. Karnofsky Performance Status (KPS) ≥ 70%.\n- 5. Adequate organ and marrow function."}
Exclusion criteria
- {"criterion_text":"- 1. Prior systemic anticancer therapy for unresectable locally advanced or metastatic RCC including investigational agents.\n- 2. Uncontrolled, significant intercurrent or recent illness including, but not limited to serious cardiovascular disorders (including uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 90 mm Hg diastolic despite optimal antihypertensive treatment), GI disorders associated with high risk for perforation or fistula formation, tumors invading GI tract, bowel obstruction, intra-abdominal abscess, clinically significant bleeding events, cavitating pulmonary lesions, or lesion invading major pulmonary blood vessels.\n- 3. Other clinically significant disorders such as: i. Autoimmune disease that has been symptomatic or required treatment within the past two years from the date of randomization. ii. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. iii. Active infection requiring systemic treatment. Acute or chronic hepatitis B or C infection, known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known positive test for tuberculosis infection where there is clinical or radiographic evidence of active mycobacterial infection. iv. Known history of COVID-19 unless the subject has clinically recovered from the disease at least 30 days prior to randomization.\n- 4. Major surgery (eg, nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization. Minor surgeries within 10 days prior to randomization. Subjects must have complete wound healing from major or minor surgery before randomization.\n- 5. Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Duration of PFS (Progression-Free Survival), per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC)","definition_or_measurement_approach":"per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), by Blinded Independent Radiology Committee (BIRC)"}
Secondary endpoints
- {"endpoint_text":"- Duration of OS (overall survival)","definition_or_measurement_approach":"Overall survival (OS) measured as duration of survival from randomization"}
Recruitment
- Planned Sample Size
- 517
- Recruitment Window Months
- 73
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent forms (Main ICF, Consent to Continue, Optional Samples ICF, Pregnant Partner ICF, Remote Visit Direct Drug Supply ICF) are provided; multiple country- and language-specific ICFs are available (document titles indicate English (EN), French (FR), Dutch/Deutsch (DU), Dutch/Netherlands (NL), Polish (PL), Italian (IT), Spanish (ES) versions). Consent is provided by the participant; partner-specific information is available for pregnant partners.
Geography
- Total Number Of Sites
- 47
- Total Number Of Participants
- 338
Belgium
- Latest Decision Or Authorization Date
- 16-10-2024
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Institut Jules Bordet
- Department Name
- Oncology
- Principal Investigator Name
- Spyridon Sideris
- Principal Investigator Email
- spyridon.sideris@hubruxelles.be
- Contact Person Name
- Spyridon Sideris
- Contact Person Email
- spyridon.sideris@hubruxelles.be
Czechia
- Latest Decision Or Authorization Date
- 17-10-2024
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Klinika Onkologie a radioterapie
- Principal Investigator Name
- Jindřich Kopecký
- Principal Investigator Email
- jindrich.kopecky@fnhk.cz
- Contact Person Name
- Jindřich Kopecký
- Contact Person Email
- jindrich.kopecky@fnhk.cz
- Site Name
- Fakultni Thomayerova nemocnice
- Department Name
- Onkologická klinika 1. LF UK a TN
- Principal Investigator Name
- Tomáš Büchler
- Principal Investigator Email
- tomas.buchler@ftn.cz
- Contact Person Name
- Tomáš Büchler
- Contact Person Email
- tomas.buchler@ftn.cz
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Onkologická klinika 2. LF UK
- Principal Investigator Name
- Kateřina Kopečková
- Principal Investigator Email
- katerina.kopeckova@fnmotol.cz
- Contact Person Name
- Kateřina Kopečková
- Contact Person Email
- katerina.kopeckova@fnmotol.cz
Finland
- Latest Decision Or Authorization Date
- 15-10-2024
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Comprehensive Cancer Center
- Principal Investigator Name
- Jalkanen Katriina
- Principal Investigator Email
- katriina.jalkanen@hus.fi
- Contact Person Name
- Jalkanen Katriina
- Contact Person Email
- katriina.jalkanen@hus.fi
- Site Name
- Pirkanmaan hyvinvointialue
- Department Name
- Department of Oncology
- Principal Investigator Name
- Krista Kankaanranta
- Principal Investigator Email
- krista.kankaanranta@pirha.fi
- Contact Person Name
- Krista Kankaanranta
- Contact Person Email
- krista.kankaanranta@pirha.fi
- Site Name
- Turku University Hospital
- Department Name
- Department of Oncology
- Principal Investigator Name
- Kalle Mattila
- Principal Investigator Email
- kalle.mattila@varha.fi
- Contact Person Name
- Kalle Mattila
- Contact Person Email
- kalle.mattila@varha.fi
Germany
- Latest Decision Or Authorization Date
- 15-10-2024
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik und Poliklinik für Urologie
- Principal Investigator Name
- Marc-Oliver Grimm
- Principal Investigator Email
- marc-oliver.grimm@med.uni-jena.de
- Contact Person Name
- Marc-Oliver Grimm
- Contact Person Email
- marc-oliver.grimm@med.uni-jena.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Department Urology and Pediatric Urology
- Principal Investigator Name
- Rene Mager
- Principal Investigator Email
- rene.mager@unimedizin-mainz.de
- Contact Person Name
- Rene Mager
- Contact Person Email
- rene.mager@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Klinik für Urologie und Kinderurologie
- Principal Investigator Name
- Martin Boegemann
- Principal Investigator Email
- Martin.boegemann@ukmuenster.de
- Contact Person Name
- Martin Boegemann
- Contact Person Email
- Martin.boegemann@ukmuenster.de
- Site Name
- National Center For Tumor Diseases (NCT) Heidelberg
- Department Name
- -
- Principal Investigator Name
- Stefanie Zschäbitz
- Principal Investigator Email
- Stefanie.zschaebitz@med.uni-heidelberg.de
- Contact Person Name
- Stefanie Zschäbitz
- Contact Person Email
- Stefanie.zschaebitz@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Department of Urology
- Principal Investigator Name
- Steffen Rausch
- Principal Investigator Email
- steffen.rausch@med.uni-tuebingen.de
- Contact Person Name
- Steffen Rausch
- Contact Person Email
- steffen.rausch@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Klinik und Poliklinik für Urologie
- Principal Investigator Name
- Angelika Borkowetz
- Principal Investigator Email
- Angelika.Borkowetz.Study@uniklinikum-dresden.de
- Contact Person Name
- Angelika Borkowetz
- Contact Person Email
- Angelika.Borkowetz.Study@uniklinikum-dresden.de
Italy
- Latest Decision Or Authorization Date
- 21-10-2024
- Number Of Sites
- 6
- Number Of Participants
- 50
Sites
- Site Name
- Azienda Ospedaliera S Maria Di Terni
- Department Name
- S.C. Oncologia
- Principal Investigator Name
- Sergio Bracarda
- Principal Investigator Email
- sergio.bracarda@gmail.com
- Contact Person Name
- Sergio Bracarda
- Contact Person Email
- sergio.bracarda@gmail.com
- Site Name
- Istituto Oncologico Veneto
- Department Name
- UOC Oncologia 1
- Principal Investigator Name
- Umberto Basso
- Principal Investigator Email
- umberto.basso@iov.veneto.it
- Contact Person Name
- Umberto Basso
- Contact Person Email
- umberto.basso@iov.veneto.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O. di Oncologia
- Principal Investigator Name
- Francesco Carrozza
- Principal Investigator Email
- francesco.carrozza@auslromagna.it
- Contact Person Name
- Francesco Carrozza
- Contact Person Email
- francesco.carrozza@auslromagna.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- U.O. Oncologia
- Principal Investigator Name
- Roberto Sabbatini
- Principal Investigator Email
- roberto.sabbatini@unimore.it
- Contact Person Name
- Roberto Sabbatini
- Contact Person Email
- roberto.sabbatini@unimore.it
- Site Name
- Istituti Clinici Scientifici Maugeri S.p.A.
- Department Name
- U.O. Oncologia
- Principal Investigator Name
- Andrea Premoli
- Principal Investigator Email
- andrea.premoli@icsmaugeri.it
- Contact Person Name
- Andrea Premoli
- Contact Person Email
- andrea.premoli@icsmaugeri.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- S.C. Oncologia Medica
- Principal Investigator Name
- Ugo De Giorgi
- Principal Investigator Email
- ugo.degiorgi@irst.emr.it
- Contact Person Name
- Ugo De Giorgi
- Contact Person Email
- ugo.degiorgi@irst.emr.it
Spain
- Latest Decision Or Authorization Date
- 14-10-2024
- Number Of Sites
- 11
- Number Of Participants
- 67
Sites
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Oncology
- Principal Investigator Name
- Emilio Esteban
- Principal Investigator Email
- eestebang@seom.org
- Contact Person Name
- Emilio Esteban
- Contact Person Email
- eestebang@seom.org
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Oncology
- Principal Investigator Name
- Javier Puente Vazquez
- Principal Investigator Email
- javierpuente.hcsc@gmail.com
- Contact Person Name
- Javier Puente Vazquez
- Contact Person Email
- javierpuente.hcsc@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Begoña Mellado González
- Principal Investigator Email
- BMELLADO@CLINIC.CAT
- Contact Person Name
- Begoña Mellado González
- Contact Person Email
- BMELLADO@CLINIC.CAT
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Maria Jose Juan Fita
- Principal Investigator Email
- mjjuan@fivo.org
- Contact Person Name
- Maria Jose Juan Fita
- Contact Person Email
- mjjuan@fivo.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Cristina Suárez Rodríguez
- Principal Investigator Email
- csuarez@vhio.net
- Contact Person Name
- Cristina Suárez Rodríguez
- Contact Person Email
- csuarez@vhio.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Jesus Garcia Donas
- Principal Investigator Email
- jgarciadonas@gmail.com
- Contact Person Name
- Jesus Garcia Donas
- Contact Person Email
- jgarciadonas@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Oncology
- Principal Investigator Name
- Jose Luis Perez Gracia
- Principal Investigator Email
- jlgracia@unav.es
- Contact Person Name
- Jose Luis Perez Gracia
- Contact Person Email
- jlgracia@unav.es
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Oncology
- Principal Investigator Name
- Maria Jose Mendez Vidal
- Principal Investigator Email
- MJOSEMV@YAHOO.ES
- Contact Person Name
- Maria Jose Mendez Vidal
- Contact Person Email
- MJOSEMV@YAHOO.ES
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Daniel Ernesto Castellano
- Principal Investigator Email
- cdanicas@hotmail.com
- Contact Person Name
- Daniel Ernesto Castellano
- Contact Person Email
- cdanicas@hotmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Oncology
- Principal Investigator Name
- Urbano Anido Herranz
- Principal Investigator Email
- urbano.anido.herranz@sergas.es
- Contact Person Name
- Urbano Anido Herranz
- Contact Person Email
- urbano.anido.herranz@sergas.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Oncology
- Principal Investigator Name
- Jose Angel Arranz Arija
- Principal Investigator Email
- jarranza.oncomed@gmail.com
- Contact Person Name
- Jose Angel Arranz Arija
- Contact Person Email
- jarranza.oncomed@gmail.com
Netherlands
- Latest Decision Or Authorization Date
- 27-10-2024
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Oncology
- Principal Investigator Name
- Astridt van der Veldt
- Principal Investigator Email
- a.vanderveldt@erasmusmc.nl
- Contact Person Name
- Astridt van der Veldt
- Contact Person Email
- a.vanderveldt@erasmusmc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Oncology
- Principal Investigator Name
- Adriaan Bins
- Principal Investigator Email
- a.d.bins@amsterdamumc.nl
- Contact Person Name
- Adriaan Bins
- Contact Person Email
- a.d.bins@amsterdamumc.nl
Poland
- Latest Decision Or Authorization Date
- 07-11-2024
- Number Of Sites
- 5
- Number Of Participants
- 101
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Rodryg Ramlau
- Principal Investigator Email
- badania.kliniczne@medpolonia.pl
- Contact Person Name
- Rodryg Ramlau
- Contact Person Email
- badania.kliniczne@medpolonia.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
- Department Name
- Oddział Onkologii Klinicznej
- Principal Investigator Name
- Piotr Centkowski
- Principal Investigator Email
- pcentek@wp.pl
- Contact Person Name
- Piotr Centkowski
- Contact Person Email
- pcentek@wp.pl
- Site Name
- Copernicus Podmiot Leczniczy Sp. z o.o.
- Department Name
- Wojewódzkie Centrum Onkologii
- Principal Investigator Name
- Joanna Wójcik-Tomaszewska
- Principal Investigator Email
- jwojcik@wco.gda.pl
- Contact Person Name
- Joanna Wójcik-Tomaszewska
- Contact Person Email
- jwojcik@wco.gda.pl
- Site Name
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
- Department Name
- Centrum Onkologii
- Principal Investigator Name
- Bogdan Żurawski
- Principal Investigator Email
- bzur1@wp.pl
- Contact Person Name
- Bogdan Żurawski
- Contact Person Email
- bzur1@wp.pl
- Site Name
- Europejskie Centrum Zdrowia Otwock Sp. z o.o.
- Department Name
- Szpital im. F. Chopina Oddział Onkologii Klinicznej
- Principal Investigator Name
- Cezary Szczylik
- Principal Investigator Email
- cezary.szczylik@ecz-otwock.pl
- Contact Person Name
- Cezary Szczylik
- Contact Person Email
- cezary.szczylik@ecz-otwock.pl
France
- Latest Decision Or Authorization Date
- 23-12-2024
- Number Of Sites
- 10
- Number Of Participants
- 69
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Oncology
- Principal Investigator Name
- Marine Gross-Goupil
- Principal Investigator Email
- marine.gross-goupil@chu-bordeaux.fr
- Contact Person Name
- Marine Gross-Goupil
- Contact Person Email
- marine.gross-goupil@chu-bordeaux.fr
- Site Name
- Institut De Cancerologie De Lorraine
- Department Name
- Oncology
- Principal Investigator Name
- Lionnel Geoffrois
- Principal Investigator Email
- l.geoffrois@nancy.unicancer.fr
- Contact Person Name
- Lionnel Geoffrois
- Contact Person Email
- l.geoffrois@nancy.unicancer.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncology
- Principal Investigator Name
- Sylvie Negrier
- Principal Investigator Email
- sylvie.negrier@lyon.unicancer.fr
- Contact Person Name
- Sylvie Negrier
- Contact Person Email
- sylvie.negrier@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Oncology
- Principal Investigator Name
- de Topart
- Principal Investigator Email
- d-topart@chu-montpellier.fr
- Contact Person Name
- de Topart
- Contact Person Email
- d-topart@chu-montpellier.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncology
- Principal Investigator Name
- Delphine Brochiellini
- Principal Investigator Email
- delphine.brochiellini@nice.unicancer.fr
- Contact Person Name
- Delphine Brochiellini
- Contact Person Email
- delphine.brochiellini@nice.unicancer.fr
- Site Name
- Institut Godinot
- Department Name
- Oncology
- Principal Investigator Name
- Jean-Christophe Eymard
- Principal Investigator Email
- jeanchristophe.eymard@reims.unicancer.fr
- Contact Person Name
- Jean-Christophe Eymard
- Contact Person Email
- jeanchristophe.eymard@reims.unicancer.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Oncology
- Principal Investigator Name
- Damien Pouessel
- Principal Investigator Email
- pouessel.damien@iuct-oncopole.fr
- Contact Person Name
- Damien Pouessel
- Contact Person Email
- pouessel.damien@iuct-oncopole.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Oncology
- Principal Investigator Name
- Philippe Barthelemy
- Principal Investigator Email
- p.barthelemy@icans.eu
- Contact Person Name
- Philippe Barthelemy
- Contact Person Email
- p.barthelemy@icans.eu
- Site Name
- Institut Gustave Roussy
- Department Name
- Oncology
- Principal Investigator Name
- Laurence Albiges
- Principal Investigator Email
- laurence.albiges@gustaveroussy.fr
- Contact Person Name
- Laurence Albiges
- Contact Person Email
- laurence.albiges@gustaveroussy.fr
- Site Name
- Clinique Victor Hugo
- Department Name
- Oncology
- Principal Investigator Name
- Eric Voog
- Principal Investigator Email
- essaisvoog@ilcgroupe.fr
- Contact Person Name
- Eric Voog
- Contact Person Email
- essaisvoog@ilcgroupe.fr
Sponsor
Primary sponsor
- Full Name
- Exelixis Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Medpace Finland Oy
- Responsibilities
- codes: 1,2,5
- Name
- Medqia LLC
- Responsibilities
- Central imaging review
- Name
- Icon Laboratory Services Inc.
- Responsibilities
- Local Lab Report Review; code 8
- Name
- Drugdev Inc.
- Responsibilities
- Site Payments
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- code 4
Third parties
- {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"codes: 1,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medqia LLC","duties_or_roles":"Central imaging review","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"Local Lab Report Review; code 8","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Drugdev Inc.","duties_or_roles":"Site Payments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- CABOMETYX 20 mg film-coated tablets
- Active Substance
- cabozantinib
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Authorised (marketing authorisation EU/1/16/1136/002)
- Starting Dose
- 20 mg (film-coated tablet)
- Maximum Dose
- 40 mg (maxDailyDoseAmount)
- Investigational Product Name
- OPDIVO 10 mg/mL concentrate for solution for infusion.
- Active Substance
- nivolumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- intravenous
- Authorisation Status
- Authorised (marketing authorisation EU/1/15/1014/002)
- Maximum Dose
- 3 mg/kg (maxDailyDoseAmount)
- Investigational Product Name
- YERVOY 5 mg/ml concentrate for solution for infusion
- Active Substance
- ipilimumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS USE
- Route
- intravenous
- Authorisation Status
- Authorised (marketing authorisation EU/1/11/698/002)
- Maximum Dose
- 1 mg/kg (maxDailyDoseAmount)
- Investigational Product Name
- Placebo Tablets matching Cabozantinib (XL184) 20mg tablets.
- Modality
- Other
- Starting Dose
- matching Cabozantinib 20 mg tablet
- Combination Treatment
- Yes
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