Clinical trial • Phase III • Oncology
NIVOLUMAB for Urothelial carcinoma (unresectable or metastatic)
Phase III trial of NIVOLUMAB for Urothelial carcinoma (unresectable or metastatic).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Urothelial carcinoma (unresectable or metastatic)
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 01-02-2024
- First CTIS Authorization Date
- 08-03-2024
Trial design
Randomised, open-label, comparator: standard of care chemotherapy arms including gemcitabine products (gemci-cell® 38 mg/ml; gemcitabine 1 g powder for solution for infusion; gemcitabine 38 mg/ml concentrate for solution for infusion) with platinum agents cisplatin (cisplatin neocorp 1 mg/ml; cisplatin teva® 1 mg/ml; cisplatin-ebewe 1 mg/ml; max daily dose listed 70 mg/m2) or carboplatin products (carbo-cell® 10 mg/ml; carboplatin bendalis 10 mg/ml; carbomedac® 10 mg/ml; max daily dose listed as 5 [unit listed as 'other']). specific administration schedules are not specified in the ctis data provided.-controlled Phase III trial in Germany, Romania, Norway and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparator: Standard of care chemotherapy arms including gemcitabine products (GEMCI-cell® 38 mg/ml; Gemcitabine 1 g Powder for Solution for Infusion; Gemcitabine 38 mg/ml Concentrate for Solution for Infusion) with platinum agents Cisplatin (Cisplatin NeoCorp 1 mg/ml; Cisplatin Teva® 1 mg/ml; CISPLATIN-EBEWE 1 mg/ml; max daily dose listed 70 mg/m2) or Carboplatin products (CARBO-cell® 10 mg/ml; Carboplatin Bendalis 10 mg/ml; Carbomedac® 10 mg/ml; max daily dose listed as 5 [unit listed as 'Other']). Specific administration schedules are not specified in the CTIS data provided.
- Biomarker Stratified
- True, PD-L1 (>=1% vs <1%)
- Target Sample Size
- 1076
Eligibility
Recruits 1076 No vulnerable populations selected. Population listed as adult patients (no paediatric subjects). Informed consent is obtained from participants; no assent/child consent procedures are described in the available CTIS data..
- Vulnerable Population
- No vulnerable populations selected. Population listed as adult patients (no paediatric subjects). Informed consent is obtained from participants; no assent/child consent procedures are described in the available CTIS data.
Inclusion criteria
- {"criterion_text":"- Metastatic or inoperable urothelial cancer\n- Must have at least 1 lesion with measurable disease\n- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work\n- No prior systemic chemotherapy treatment in the metastatic setting"}
Exclusion criteria
- {"criterion_text":"- Patients with ECOG PS >= 2\n- Patients with disease that is suitable for local therapy administered with curative intent\n- Patients with active brain metastases or leptomeningeal metastases\n- Patients with active, known or suspected autoimmune disease\n- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n- Participants may not have received live/attenuated vaccines within 30 days prior to first study treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Primary endpoint of OS in cisplatin-ineligible randomized participants","definition_or_measurement_approach":"Overall Survival (OS)"}
- {"endpoint_text":"- Primary endpoint of OS in PD-L1 positive (>= 1%) randomized participants by immunohistochemistry (IHC)","definition_or_measurement_approach":"Overall Survival (OS) in PD-L1 positive (>= 1%) randomized participants assessed by immunohistochemistry (IHC)"}
Secondary endpoints
- {"endpoint_text":"- OS in all randomized participants","definition_or_measurement_approach":"Overall Survival (OS)"}
- {"endpoint_text":"- PFS by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (>=1%) randomized participants and in all randomized participants","definition_or_measurement_approach":"Progression-Free Survival (PFS) assessed by blinded independent central review (BICR) using RECIST 1.1"}
- {"endpoint_text":"- European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants","definition_or_measurement_approach":"EORTC QLQ-C30 Global Health Status score (health-related quality of life measure)"}
Recruitment
- Planned Sample Size
- 1076
- Recruitment Window Months
- 102
- Consent Approach
- Informed consent obtained from adult participants. Subject information sheets and informed consent forms (L1_SIS and ICF) are provided and available in multiple country/language versions (examples in the public documents include Polish (PL), Greek (GR), Czech (CZ), Spanish (ES), French (FR), Dutch (NL), Italian (IT) and others). No assent/child consent procedures are described in the CTIS data.
Geography
- Total Number Of Sites
- 42
- Total Number Of Participants
- 701
Germany
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 13-03-2024
- Processing Time Days
- 23
- Number Of Sites
- 8
- Number Of Participants
- 92
Sites
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik f. Innere Medizin I
- Contact Person Name
- Cornelius Waller
- Contact Person Email
- cornelius.waller@uniklinik-freiburg.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Medizinische Klinik 5
- Contact Person Name
- Marinela Augustin
- Contact Person Email
- marinela.augustin@klinikum-nuernberg.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Universitaetsklinik fuer Urologie
- Contact Person Name
- Steffen Rausch
- Contact Person Email
- steffen.rausch@med.uni-tuebingen.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Klinik f. Urologie
- Contact Person Name
- christian Wuelfing
- Contact Person Email
- c.wuelfing@asklepios.com
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik f Urologie und Urologische Onkologie
- Contact Person Name
- Christoph von Klot
- Contact Person Email
- klot.christoph@mh-hannover.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Studienbuero Urologie
- Contact Person Name
- Marc-Oliver Grimm
- Contact Person Email
- marc-oliver.grimm@med.uni-jena.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Interdisziplinäres Studienzentrum (ISZ) mit ECTU (Haus C16)
- Contact Person Name
- Hubert Kuebler
- Contact Person Email
- kuebler_h@ukw.de
- Site Name
- Universitat Heidelberg
- Department Name
- Urologische Klinik
- Contact Person Name
- Frederik Wessels
- Contact Person Email
- frederik.wessels@medma.uni-heidelberg.de
Romania
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 31
- Number Of Sites
- 2
- Number Of Participants
- 75
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Oncology
- Contact Person Name
- Tudor Ciuleanu
- Contact Person Email
- office@iocn.ro
- Site Name
- Centrul De Oncologie SF Nectarie S.R.L.
- Department Name
- Oncology
- Contact Person Name
- Michael Schenker
- Contact Person Email
- centruldeoncologie@yahoo.com
Norway
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 08-03-2024
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Akershus University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Jan Oldenburg
- Contact Person Email
- Jan.oldenburg@medisin.uio.no
Denmark
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Herlev Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Lene Sonne Mouritsen
- Principal Investigator Email
- lene.sonne.mouritsen@regionh.dk
- Contact Person Name
- Lene Sonne Mouritsen
- Contact Person Email
- lene.sonne.mouritsen@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Andreas Carus
- Principal Investigator Email
- andreas.carus@rn.dk
- Contact Person Name
- Andreas Carus
- Contact Person Email
- andreas.carus@rn.dk
Poland
- Earliest CTIS Part Ii Submission Date
- 14-05-2024
- Latest Decision Or Authorization Date
- 20-03-2024
- Number Of Sites
- 1
- Number Of Participants
- 35
Sites
- Site Name
- Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
- Department Name
- Oddział Dzienny Chemioterapii
- Contact Person Name
- Mariusz Kwiatkowski
- Contact Person Email
- szpital@swk.med.pl
Greece
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 22-04-2024
- Processing Time Days
- 63
- Number Of Sites
- 2
- Number Of Participants
- 70
Sites
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Oncology Clinic
- Contact Person Name
- Davide Mauri
- Contact Person Email
- dvd.mauri@gmail.com
- Site Name
- Alexandra Hospital
- Department Name
- Department of Clinical Therapeutics
- Contact Person Name
- Michalis Liontos
- Contact Person Email
- mliontos@gmail.gr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 70
Sites
- Site Name
- Medisch Centrum Leeuwarden B.V.
- Department Name
- Medische Oncologie
- Contact Person Name
- Marco-Ben Polée
- Contact Person Email
- Wetenschap@mclacademie.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Medische Oncologie
- Contact Person Name
- Sjoukje Oosting
- Contact Person Email
- info@medischeoncologiegroningen.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Medische Oncologie
- Contact Person Name
- Michiel van der Heijden
- Contact Person Email
- communicatie@nki.nl
Czechia
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Klinika onkologie a radioterapie
- Contact Person Name
- Jindrich Kopecky
- Contact Person Email
- jindrich.kopecky@fnhk.cz
- Site Name
- Masarykuv Onkologicky Ustav
- Department Name
- Klinika komplexni onkologicke pece
- Contact Person Name
- Alexandr Poprach
- Contact Person Email
- poprach@mou.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 21
- Number Of Sites
- 7
- Number Of Participants
- 85
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Oncologia
- Contact Person Name
- Teresa Alonso
- Contact Person Email
- talonso@oncologiahrc.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Oncologia Medica
- Contact Person Name
- Begoña Perez Valderrama
- Contact Person Email
- bpvalderrama@gmail.com
- Site Name
- Fundacion Instituto Valenciano De Oncologia
- Department Name
- Unidad Investigacion Clinica
- Contact Person Name
- Miguel Angel Climent
- Contact Person Email
- macliment@fivo.org
- Site Name
- Complejo Hospitalario Universitario Juan Canalejo
- Department Name
- Oncologia
- Contact Person Name
- Aurea Molina Diaz
- Contact Person Email
- aurea.molina.diaz@sergas.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Oncologia Medica
- Contact Person Name
- Ignacio Duran
- Contact Person Email
- ignaciojose.duran@scsalud.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncologia
- Contact Person Name
- Daniel Castellano
- Contact Person Email
- cdanicas@hotmail.com
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Genitourinari Oncologia Medica
- Contact Person Name
- Jose Pablo Maroto
- Contact Person Email
- jmaroto@santpau.cat
France
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 12-03-2024
- Processing Time Days
- 22
- Number Of Sites
- 7
- Number Of Participants
- 144
Sites
- Site Name
- Hospital Foch
- Department Name
- Medical Oncology
- Contact Person Name
- Christine Abraham
- Contact Person Email
- c.abraham@hopital-foch.com
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Oncology
- Contact Person Name
- Pierre Cornillon
- Contact Person Email
- pierre.cornillon@chuse.fr
- Site Name
- Centre Oscar Lambret
- Department Name
- Urological and Digestive Oncology
- Contact Person Name
- Aurélien Carnot
- Contact Person Email
- a-carnot@o-lambret.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Medical Oncology
- Contact Person Name
- Nadine Houédé
- Contact Person Email
- Nadine.houede@chu-nimes.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Medical Oncology
- Contact Person Name
- Loriot Yohann
- Contact Person Email
- yohann.loriot@gustaveroussy.fr
- Site Name
- Institut Paoli-Calmettes
- Department Name
- Medical Oncology
- Contact Person Name
- Gwenaëlle Gravis
- Contact Person Email
- gravisg@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Oncology
- Contact Person Name
- Bérengère Narciso
- Contact Person Email
- berengere.narciso@univ-tours.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 19-02-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 31
- Number Of Sites
- 7
- Number Of Participants
- 89
Sites
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O di Oncologia
- Contact Person Name
- Francesco Carrozza
- Contact Person Email
- francesco.carrozza@auslromagna.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Oncologia medica genitourinaria
- Contact Person Name
- Melanie Claps
- Contact Person Email
- melanie.claps@istitutotumori.mi.it
- Site Name
- Azienda USL Toscana Sud Est
- Department Name
- U.O.C Oncologia Medica 1
- Contact Person Name
- Alketa Hamzaj
- Contact Person Email
- alketa.hamzaj@uslsudest.toscana.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O di Oncologia
- Contact Person Name
- Francesco Carrozza
- Contact Person Email
- francesco.carrozza@auslromagna.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Oncologia Medica
- Contact Person Name
- Giuseppe Schepisi
- Contact Person Email
- giuseppe.schepisi@irst.emr.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O di Oncologia
- Contact Person Name
- Francesco Carrozza
- Contact Person Email
- francesco.carrozza@auslromagna.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O di Oncologia
- Contact Person Name
- Francesco Carrozza
- Contact Person Email
- francesco.carrozza@auslromagna.it
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Icon (Lr) Limited
- Responsibilities
- Routine clin pathology test,Clin chemistry,Clin haematol,Clin microbiol,Histopathol,Serol/endocrinol,Analytical chemistry,Primary/surrogate endpoint test,spl mgmt,kit-supply provision,storage & distri for anal,pathology report receipt,PBMC processing
- Name
- PAREXEL INTERNATIONAL (IRL) Limited
- Responsibilities
- Subject Number assignment, Treatment/Arm assignment, Drug (re)supplies assignment
- Name
- PPD Development LP
- Responsibilities
- Serum PK and serum immunogenicity analysis
- Name
- Bioclinica Inc.
- Responsibilities
- Collection of de-identified images; Imaging doc development; Independent reader training;...
Third parties
- {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Routine clin pathology test,Clin chemistry,Clin haematol,Clin microbiol,Histopathol,Serol/endocrinol,Analytical chemistry,Primary/surrogate endpoint test,spl mgmt,kit-supply provision,storage & distri for anal,pathology report receipt,PBMC processing","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Cellcarta Fremont LLC","duties_or_roles":"Myeloid Derived Suppressor Cells (MDSCs) analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"Specialty Biomarker Laboratory, Exploratory Serum Biomarker analysis","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Serum PK and serum immunogenicity analysis","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Various operational support (codes referenced in CTIS data)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"PAREXEL INTERNATIONAL (IRL) Limited","duties_or_roles":"Subject Number assignment, Treatment/Arm assignment, Drug (re)supplies assignment","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Collection of de-identified images; Imaging doc development; Independent reader training;...","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Icon Laboratories Inc.","duties_or_roles":"Data entry of Local Laboratory Values","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"Specialty Biomarker Laboratory,IHC Biomarker expression analysis (PD-L1)","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 USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- max daily dose 480 mg (max total dose 4080 mg)
- 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 USE
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- max daily dose 3 mg/Kg (max total dose 12 mg/Kg)
- Investigational Product Name
- GEMCI-cell® 38 mg/ml Konzentrat zur Herstellung einer Infusionslösung / Gemcitabine products
- Active Substance
- GEMCITABINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- max daily dose 1000 mg/m2 (max total dose 12000 mg/m2)
- Investigational Product Name
- Cisplatin products (Cisplatin NeoCorp / Cisplatin Teva® / CISPLATIN-EBEWE)
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- max daily dose 70 mg/m2 (max total dose 420 mg/m2)
- Investigational Product Name
- Carboplatin products (CARBO-cell® / Carboplatin Bendalis / Carbomedac®)
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised (prodAuthStatus=2)
- Maximum Dose
- max daily dose 5 (unit listed as 'Other')
- Combination Treatment
- Yes
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