Clinical trial • Phase III • Oncology

N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE for Renal cell carcinoma | Advanced renal cell carcinoma

Phase III trial of N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE for Renal cell carcinoma…

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Renal cell carcinoma | Advanced renal cell carcinoma
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-07-2025
First CTIS Authorization Date
10-11-2025

Trial design

Randomised, open-label, cabozantinib (cabozantinib ipsen 20 mg film-coated tablets and cabozantinib ipsen 60 mg film-coated tablets) — specific dose schedule not specified in the provided data.-controlled Phase III trial in Austria, Greece, Croatia and others.

Randomised
Yes
Open Label
Yes
Comparator
Cabozantinib (Cabozantinib Ipsen 20 mg film-coated tablets and Cabozantinib Ipsen 60 mg film-coated tablets) — specific dose schedule not specified in the provided data.
Target Sample Size
506

Eligibility

Recruits 506 No vulnerable populations are selected for this trial (isVulnerablePopulationSelected: false). Informed consent is obtained from adult participants; site-specific adult consent forms (L1_ICF_Main consent documents) are provided for participating countries and are available in local languages per site..

Vulnerable Population
No vulnerable populations are selected for this trial (isVulnerablePopulationSelected: false). Informed consent is obtained from adult participants; site-specific adult consent forms (L1_ICF_Main consent documents) are provided for participating countries and are available in local languages per site.

Inclusion criteria

  • {"criterion_text":"- Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV renal cell cancer per AJCC (8th Edition).\n- Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).\n- Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapy.\n- Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy."}

Exclusion criteria

  • {"criterion_text":"- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n- Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization.\n- Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram.\n- Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications.\n- Has not adequately recovered from major surgery or has ongoing surgical complications.\n- Has current pneumonitis/interstitial lung disease.\n- Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization.\n- Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation.\n- Has a serious active nonhealing wound/ulcer/bone fracture.\n- Has a requirement for hemodialysis or peritoneal dialysis.\n- Has history of human immunodeficiency virus infection.\n- Has hepatitis B or hepatitis C virus.\n- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression free survival","definition_or_measurement_approach":"PFS per RECIST 1.1 as assessed by BICR (Blinded Independent Central Review)."}
  • {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Overall survival (OS) — time to death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- Objective Response Rate","definition_or_measurement_approach":"ORR per RECIST 1.1 as assessed by BICR."}
  • {"endpoint_text":"- Duration of Response","definition_or_measurement_approach":"DOR per RECIST 1.1 as assessed by BICR."}
  • {"endpoint_text":"- Number of participants with ≥1 AE(s)","definition_or_measurement_approach":"Count of participants experiencing one or more adverse events (AEs) during study treatment (safety assessment)."}
  • {"endpoint_text":"- Number of participants who discontinue study therapy due to AE(s)","definition_or_measurement_approach":"Count of participants discontinuing study therapy because of adverse events."}
  • {"endpoint_text":"- Change from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) global health/health-related quality of life (HRQoL) score","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 global health/HRQoL score."}
  • {"endpoint_text":"- Change from baseline in EORTC QLC-C30 physical functioning score","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 physical functioning subscale."}
  • {"endpoint_text":"- Change from baseline in EORTC QLQ-C30 role functioning score","definition_or_measurement_approach":"Change from baseline measured using EORTC QLQ-C30 role functioning subscale."}
  • {"endpoint_text":"- Change from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) score","definition_or_measurement_approach":"Change from baseline measured using the FKSI-DRS instrument."}
  • {"endpoint_text":"- Time from baseline to first deterioration in EORTC-QLC-C30 global health/HRQoL score","definition_or_measurement_approach":"Time-to-event endpoint using EORTC QLQ-C30 global health/HRQoL score to define deterioration."}
  • {"endpoint_text":"- Time from baseline to first deterioration in EORTC-QLC-C30 physical functioning score","definition_or_measurement_approach":"Time-to-event endpoint using EORTC QLQ-C30 physical functioning subscale to define deterioration."}
  • {"endpoint_text":"- Time from baseline to first deterioration in EORTC-QLC-C30 role functioning score","definition_or_measurement_approach":"Time-to-event endpoint using EORTC QLQ-C30 role functioning subscale to define deterioration."}
  • {"endpoint_text":"- Time from baseline to first deterioration in FKSI-DRS score","definition_or_measurement_approach":"Time-to-event endpoint using FKSI-DRS to define first deterioration."}

Recruitment

Planned Sample Size
506
Recruitment Window Months
72
Consent Approach
Informed consent is obtained from adult participants using country- and site-specific L1_ICF_Main consent forms. Optional supplementary consent forms (e.g. pregnancy follow-up, partner forms, optional samples) are available for some countries. Consent documents are provided in local languages (examples present: English, German, French, Spanish, Italian, Polish, Czech, Croatian, Greek, Dutch) as indicated by country-specific L1_ICF and recruitment documents.

Geography

Total Number Of Sites
81
Total Number Of Participants
398

Austria

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
125
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Abteilung für Urologie und Andrologie
Contact Person Name
Clemens Mayr
Contact Person Email
clemens.mayr@ordensklinikum.at
Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
1. Klinische Abteilung Zentrum für Onkologie und Hämatlogie
Contact Person Name
Dora Niedersüss-Beke
Site Name
Medical University Of Vienna
Department Name
Universitätsklinik für Urologie
Contact Person Name
Manuela Schmidinger

Greece

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
210
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Propaedeutic Internal Medicine Department
Contact Person Name
Bamias Aristotelis
Contact Person Email
abamias@med.uoa.gr
Site Name
Alexandra Hospital
Department Name
Oncology – Hematology Department – Unit of Plasma Cell Dyscrasias, University of Athens
Contact Person Name
Liontos Michalis
Contact Person Email
mliontos@gmail.com
Site Name
Metropolitan Hospital
Department Name
2nd Oncology Department, 2nd Building
Contact Person Name
Christos Christodoulou

Croatia

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
27-02-2026
Processing Time Days
140
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
University Hospital Centre Zagreb
Department Name
Oncology Clinic, Department of Urogenital Tumors
Contact Person Name
Marija Gamulin
Contact Person Email
marija.gamulin@kbc-zagreb.hr
Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
Clinic for Oncology and Nuclear Medicine
Contact Person Name
Marijana Jazvic
Contact Person Email
marijana.jazvic@kbcsm.hr
Site Name
KBC Split
Department Name
Clinic for Oncology and Radiotherapy
Contact Person Name
Tomislav Omrcen
Contact Person Email
onkologija@kbsplit.hr

Poland

Earliest CTIS Part Ii Submission Date
07-10-2025
Latest Decision Or Authorization Date
26-02-2026
Processing Time Days
142
Number Of Sites
8
Number Of Participants
27

Sites

Site Name
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej i Radioterapii
Contact Person Name
Lubomir Bodnar
Contact Person Email
bbk@szpital.siedlce.pl
Site Name
Pratia S.A.
Department Name
MTZ Clinical Research Powered by Pratia
Contact Person Name
Krzysztof Woźniak
Contact Person Email
info@pratia.com
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Żurawski
Site Name
Aidport Sp. z o.o.
Department Name
Poradnia Onkologiczna
Contact Person Name
Piotr Tomczak
Contact Person Email
rejestracja@aidport.pl
Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Site Name
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Department Name
Oddział Onkologiczny z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Kamil Kuć
Contact Person Email
kkuc@wszp.pl
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennym
Contact Person Name
Anna Kowalczyk-Tekiela
Site Name
Pratia MCM Kraków
Department Name
Pratia MCM Kraków
Contact Person Name
Aleksandra Grela-Wojewoda
Contact Person Email
biuro.mcm@pratia.com

Czechia

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
137
Number Of Sites
7
Number Of Participants
38

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Onkologicka klinika 2. LF UK a FN Motol
Contact Person Name
Tomas Buchler
Contact Person Email
tomas.buchler@fnmotol.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Onkologicka klinika
Contact Person Name
Pavla Sormova
Contact Person Email
pavla.sormova@fno.cz
Site Name
Nemocnice Ceske Budejovice a.s.
Department Name
Onkologicka klinika
Contact Person Name
Pavel Vlcek
Contact Person Email
vlcek.pavel@nemcb.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexni onkologicke pece
Contact Person Name
Alexandr Poprach
Contact Person Email
poprach@mou.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Onkologicka klinika
Contact Person Name
Martin Mateju
Contact Person Email
martin.mateju@vfn.cz
Site Name
University Hospital Olomouc
Department Name
Onkologicka klinika
Contact Person Name
Hana Studentova
Contact Person Email
hana.studentova@fnol.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Contact Person Name
Jindrich Kopecky
Contact Person Email
jindrich.kopecky@fnhk.cz

Belgium

Earliest CTIS Part Ii Submission Date
13-10-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
151
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Oncology
Contact Person Name
Emmanuel Seront
Site Name
UZ Leuven
Department Name
Oncology
Contact Person Name
Benoit Beuselinck
Contact Person Email
benoit.beuselinck@uzleuven.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Oncology
Contact Person Name
Wendy De Roock
Contact Person Email
wendy.deroock@zol.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Oncology
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@ugent.be

Italy

Earliest CTIS Part Ii Submission Date
26-09-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
152
Number Of Sites
14
Number Of Participants
50

Sites

Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
Oncologia Medica
Contact Person Name
Sarah Scagliarini
Site Name
Azienda Unita' Sanitaria Locale Toscana Sud Est
Department Name
U.O.C. Oncologia medica
Contact Person Name
Alketa Hamzaj
Site Name
Istituto Oncologico Veneto
Department Name
UOC Oncologia 3
Contact Person Name
Marco Maruzzo
Contact Person Email
marco.maruzzo@iov.veneto.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Oncologia Medica Genitourinaria
Contact Person Name
Giuseppe Peocopio
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
Oncologia Medica 1
Contact Person Name
Fabio Calabrò
Contact Person Email
fabio.calabro@ifo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Oncologia Medica
Contact Person Name
Roberto Iacovelli
Site Name
Humanitas Mirasole S.p.A.
Department Name
SSM Oncologia Medica ed Ematologia
Contact Person Name
Paolo Zucali
Contact Person Email
paolo.zucali@hunimed.eu
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Oncologia Medica
Contact Person Name
Francesco Massari
Contact Person Email
francesco.massari@aosp.bo.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
UOC Oncologia Medica
Contact Person Name
Sebastiano Buti
Contact Person Email
sbuti@ao.pr.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Oncologia Medica 1
Contact Person Name
Giuseppe Forniarini
Site Name
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
Department Name
Dipartimento Interdisciplinare di Medicina & U.O.C.U. di Oncologia Medica
Contact Person Name
Camillo Porta
Contact Person Email
studiclinici.porta@gmail.com
Site Name
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.
Department Name
U. O. Oncologia
Contact Person Name
Davide Pastorelli
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
S.C.D.U. Oncologia Medica
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Oncologia Medica
Contact Person Name
Lorenzo Antonuzzo

Ireland

Earliest CTIS Part Ii Submission Date
10-10-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
137
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
St Vincent's University Hospital
Department Name
Oncology
Contact Person Name
Raymond McDermott
Contact Person Email
Ray.mcdermott@ccrt.ie
Site Name
Tallaght University Hospital
Department Name
Oncology
Contact Person Name
Raymond McDermott
Contact Person Email
ray.mcdermott@ccrt.ie
Site Name
Cork University Hospital
Department Name
Oncology
Contact Person Name
Jack Gleeson
Contact Person Email
Jack.Gleeson@hse.ie

Germany

Earliest CTIS Part Ii Submission Date
23-10-2025
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
131
Number Of Sites
11
Number Of Participants
52

Sites

Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Klinik für Urologie und Transplantationschirurgie
Contact Person Name
Jens Bedke
Contact Person Email
j.bedke@klinikum-stuttgart.de
Site Name
Universitaetsmedizin Goettingen
Department Name
Studienzentrum UMG und Klinik für Urologie
Contact Person Name
Arne Strauß
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Universitätsklinik für Urologie
Contact Person Name
Steffen Rausch
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik und Poliklinik für Urologie
Contact Person Name
Marc-Oliver Grimm
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Urologie
Contact Person Name
Christian Thomas
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Urologie
Contact Person Name
Victor Schuettfort
Contact Person Email
v.schuettfort@uke.de
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Klinik für Urologie
Contact Person Name
Karl Heinrich Tully
Contact Person Email
Karl.Tully@elisabethgruppe.de
Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Abteilung für Urologie
Contact Person Name
Thomas Steiner
Site Name
HELIOS Kliniken Schwerin GmbH
Department Name
Klinik für Urologie
Contact Person Name
Tobias Severin
Site Name
Universitaetsklinikum Muenster AöR
Department Name
Klinik für Urologie
Contact Person Name
Martin Bögemann
Contact Person Email
martin.boegemann@ukmuenster.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Urologie
Contact Person Name
Barbara Erber
Contact Person Email
barbara.erber@charite.de

Spain

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
145
Number Of Sites
11
Number Of Participants
62

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Ignacio Duran Martinez
Contact Person Email
ignacioduranmartinez@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Imanol Martinez Salas
Contact Person Email
imanol.martinez@quironsalud.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Javier Molina Cerrillo
Contact Person Email
javier.molinace@gmail.com
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncology
Contact Person Name
Nuria Sala Gonzalez
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Cristina Suarez Rodriguez
Contact Person Email
csuarez@vhio.net
Site Name
Institut Catala D'oncologia (L'hospitalet)
Department Name
Oncology
Contact Person Name
Mayra Orrillo Sarmiento
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Guillermo de Velasco Oria de Rueda
Contact Person Email
gdevelasco.gdv@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncology
Contact Person Name
Miguel Angel Climent Duran
Contact Person Email
macliment@fivo.org
Site Name
Hospital Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Maria Jose Mendez-Vidal
Contact Person Email
mjosemv@yahoo.es
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat

France

Earliest CTIS Part Ii Submission Date
31-07-2025
Latest Decision Or Authorization Date
23-02-2026
Processing Time Days
207
Number Of Sites
13
Number Of Participants
67

Sites

Site Name
Centre Hospitalier De La Cote Basque
Department Name
Service d'oncologie medicale
Contact Person Name
Louis FRANCOIS
Contact Person Email
lfrancois@ch-cotebasque.fr
Site Name
Medipole De Nancy
Department Name
Service d'oncologie medicale
Contact Person Name
Raafet AFFI
Contact Person Email
r.affi@ilcgroupe.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service d'urologie
Contact Person Name
Pierre BIGOT
Contact Person Email
PiBigot@chu-angers.fr
Site Name
Hospital Foch
Department Name
Service d'oncologie medicale
Contact Person Name
Yann-Alexandre VANO
Contact Person Email
y.vano@hopital-foch.com
Site Name
Hospices Civils De Lyon
Department Name
Service d'oncologie medicale
Contact Person Name
Denis MAILLET
Contact Person Email
denis.maillet@chu-lyon.fr
Site Name
Centre De Cancerologue Du Grand Montpellier
Department Name
Service d'oncologie medicale
Contact Person Name
Catherine BECHT
Contact Person Email
becht@ccgm.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Service d'urologie
Contact Person Name
Laetitia AUGUSTO
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'oncologie
Contact Person Name
Charlotte JOLY
Contact Person Email
charlotte.joly@aphp.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Hemato-Oncologie
Contact Person Name
Charlotte GREILSAMER
Contact Person Email
charlotte.greilsamer@ght85.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'oncologie medicale
Contact Person Name
Marine GROSS-GOUPIL
Site Name
CHU Besancon
Department Name
Service d'oncologie medicale
Contact Person Name
Hamadi ALMOTLAK
Contact Person Email
halmotlak@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service d'oncologie medicale
Contact Person Name
Mathieu LARAMAS
Contact Person Email
mlaramas@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire D'Angers (duplicate listing?)
Department Name
Service d'urologie
Contact Person Name
Pierre BIGOT
Contact Person Email
PiBigot@chu-angers.fr

Denmark

Earliest CTIS Part Ii Submission Date
08-10-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
139
Number Of Sites
3
Number Of Participants
17

Sites

Site Name
Region Hovedstaden
Department Name
Deparment of Oncology, KFE
Contact Person Name
Anne Kirstine Møller Darras
Site Name
Region Midtjylland
Department Name
Deparment of Oncology, KFE
Contact Person Name
Niels Fristrup
Contact Person Email
niels.fristrup@rm.dk
Site Name
Odense University Hospital
Department Name
Deparment of Oncology, KFE
Contact Person Name
Niels Viggo Jensen
Contact Person Email
niels.viggo.jensen@rsyd.dk

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Almac Clinical Technologies LLC
Responsibilities
code 3
Name
Sampled (formerly Infinity Biologix)
Responsibilities
code 4
Name
Clario
Responsibilities
Imaging (code 15)
Name
Medidata Solutions Inc.
Responsibilities
code 7
Name
PPD Global Central Labs
Responsibilities
code 4
Name
Discovery Life Sciences LLC
Responsibilities
code 4
Name
Resolian Bioanalytics
Responsibilities
code 4
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services) (code 15)
Name
Almac Diagnostic Services Limited
Responsibilities
code 4

Third parties

  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [{\"id\":854035,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Sampled (formerly Infinity Biologix)","duties_or_roles":"sponsorDuties codes: [{\"id\":854037,\"code\":\"4\"}]","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"sponsorDuties codes: [{\"id\":854036,\"code\":\"15\",\"value\":\"Imaging\"}]","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [{\"id\":854041,\"code\":\"7\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: [{\"id\":854038,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"sponsorDuties codes: [{\"id\":854042,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Resolian Bioanalytics","duties_or_roles":"sponsorDuties codes: [{\"id\":854039,\"code\":\"4\"}]","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties codes: [{\"id\":854040,\"code\":\"15\",\"value\":\"EUB services (call center and medical services)\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"sponsorDuties codes: [{\"id\":854043,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Exelixis

Investigational products

Investigational Product Name
XL092
Active Substance
N-(4-FLUOROPHENYL)-N-(4-((7-METHOXY-6-(METHYLCARBAMOYL)QUINOLIN-4-YL)OXY)PHENYL)CYCLOPROPANE-1,1-DICARBOXAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Investigational (prodAuthStatus 1)
Investigational Product Name
BELZUTIFAN
Active Substance
BELZUTIFAN
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus 2)
Investigational Product Name
Cabozantinib Ipsen 20 mg film-coated tablets
Active Substance
CABOZANTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus 2)
Investigational Product Name
Cabozantinib Ipsen 60 mg film-coated tablets
Active Substance
CABOZANTINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus 2)
Combination Treatment
Yes

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