Clinical trial • Phase III • Oncology

BELZUTIFAN for Advanced renal cell carcinoma (clear cell)

Phase III trial of BELZUTIFAN for Advanced renal cell carcinoma (clear cell).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced renal cell carcinoma (clear cell)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-02-2024
First CTIS Authorization Date
21-03-2024

Trial design

Randomised, open-label, comparator arm: cabozantinib (oral; max daily dose 60 mg as recorded). experimental arm: belzutifan (oral; max daily dose 120 mg) in combination with lenvatinib (oral; max daily dose 20 mg).-controlled Phase III trial in Finland, Greece, Ireland and others.

Randomised
Yes
Open Label
Yes
Comparator
Comparator arm: Cabozantinib (oral; max daily dose 60 mg as recorded). Experimental arm: Belzutifan (oral; max daily dose 120 mg) in combination with Lenvatinib (oral; max daily dose 20 mg).
Target Sample Size
347

Eligibility

Recruits 347 No vulnerable populations selected; study population are adult participants. Informed consent is required from participants (no assent procedures for minors are mentioned)..

Pregnancy Exclusion
A female participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
Vulnerable Population
No vulnerable populations selected; study population are adult participants. Informed consent is required from participants (no assent procedures for minors are mentioned).

Inclusion criteria

  • {"criterion_text":"- Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).\n- Adequate organ function.\n- Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose.\n- Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.\n- Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.\n- Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease\n- Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/metastatic RCC.\n- A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.\n- A female participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.\n- Adequately controlled blood pressure."}

Exclusion criteria

  • {"criterion_text":"- A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.\n- History of solid organ transplantation.\n- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n- Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).\n- Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.\n- Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization.\n- Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.\n- Prior treatment with lenvatinib.\n- Prior treatment with cabozantinib.\n- Currently participating in a study of an investigational agent or using an investigational device.\n- Active infection requiring systemic therapy.\n- Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.\n- History of human immunodeficiency virus (HIV) infection.\n- History of hepatitis B or known active hepatitis C infection.\n- Known central nervous system (CNS) metastases and/or carcinomatous meningitis.\n- Clinically significant cardiac disease within 6 months of first dose of study intervention.\n- Prolongation of QTc interval to >480 ms.\n- Symptomatic pleural effusion (e.g., cough, dyspnea, pleuritic chest pain) that is not clinically stable.\n- Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.\n- Moderate to severe hepatic impairment.\n- History of significant bleeding within 3 months before randomization."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"PFS per RECIST 1.1 assessed by Blinded Independent Central Review (BICR)"}
  • {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall survival measured as time from randomization to death from any cause"}

Secondary endpoints

  • {"endpoint_text":"- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"ORR per RECIST 1.1 assessed by BICR"}
  • {"endpoint_text":"- Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"DOR per RECIST 1.1 assessed by BICR"}
  • {"endpoint_text":"- Number of Participants Who Experienced One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants with ≥1 AE (safety reporting)"}
  • {"endpoint_text":"- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants who permanently discontinued study treatment due to an AE"}

Recruitment

Registry Or Advocacy Recruitment
True, IKNL (Netherlands)
Digital Remote Recruitment
True — digital channels explicitly referenced include Google advertisement campaigns and social media campaigns (country-specific documents for NLD, CZE, DEU).
Planned Sample Size
347
Recruitment Window Months
71
Consent Approach
Informed consent obtained from adult participants using country- and language-specific ICFs. Multiple ICF documents and addenda exist for different countries/languages (examples: FIN, GRC, CZE, FRA, NLD, ITA, IRL, DEU, POL, ESP, BEL). Addenda for disease progression and optional modules (e.g., pregnant partner forms, data privacy) are provided. No assent procedures for minors are described.

Methods

  • Google advertisement campaigns (e.g. document titles: 'K2_Recruitment Doc Advertisement_GOOGLE adv_NLD_NL_for pub', 'K2_Recruitment Doc Google campaign_CZE_CS_for pub') — digital ads targeted to prospective participants, country-specific (Netherlands, Czechia).
  • Social media recruitment (document: 'K2_Recruitment Doc Social Media_DEU_DE_for pub') — digital/social channels used in Germany.
  • Physician referral and site-based flyers (document: 'K2_Recruitment Doc Physician Referral Flyer_DEU_DE_for pub') — clinician/clinic referral materials used in Germany.
  • Clinical trial brochures and patient brochures (multiple 'K2_Recruitment Doc Patient Brochure' documents in various languages) — printed informational materials for patients in country-specific languages.
  • Site patient visit guides and dosing diaries (documents titled 'L1_Patient visit guide', 'L1_Patient dosing diary') — materials provided to enrolled patients at sites.
  • National cancer organisation collaboration/advertisement (document: 'K2_Recruitment Doc Advertisement_IKNL_NLD_NL_for pub') — Netherlands-specific recruitment via IKNL channel.

Geography

Total Number Of Sites
69
Total Number Of Participants
361

Finland

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
22-03-2024
Processing Time Days
9
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Turku University Hospital
Department Name
TYKS Cancer Centre
Contact Person Name
Vesa Väliaho
Contact Person Email
vesa.valiaho@varha.fi
Site Name
HUS-Yhtymae
Department Name
HUCH Comprehensive Cancer Center, Clinical Trial Unit
Contact Person Name
Katriina Jalkanen
Contact Person Email
katriina.jalkanen@hus.fi

Greece

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
13-05-2024
Processing Time Days
61
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Alexandra Hospital
Department Name
Department of Clinical Therapeutics, Oncology-Hematology department, Unit of Plasma cell dyscrasias
Contact Person Name
Flora Zagouri
Contact Person Email
florazagouri@yahoo.co.uk
Site Name
General University Hospital Of Patras
Department Name
Division of Oncology-Department of Medicine
Contact Person Name
Angelos Koutras
Contact Person Email
angkoutr@otenet.gr
Site Name
Athens Medical Center S.A. (Thessaloniki site)
Department Name
European Interbalkan Medical Center Thessaloniki Oncology Department
Contact Person Name
Sofia Baka
Contact Person Email
bakasofia@hotmail.com
Site Name
Athens Medical Center S.A. (Maroussi)
Department Name
Athens Medical Center Department of Internal Medicine-Oncology
Contact Person Name
Marinos Tsiatas
Contact Person Email
tsiatas@hotmail.com
Site Name
University General Hospital Attikon
Department Name
B' Propaedeutic Internal Medicine Department
Contact Person Name
Aristotelis Bamias
Contact Person Email
abamias@med.uoa.gr

Ireland

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
21-03-2024
Processing Time Days
8
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Tallaght University Hospital
Department Name
Oncology
Contact Person Name
Ray McDermott
Contact Person Email
ray.mcdermott@tuh.ie

Netherlands

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
21-03-2024
Processing Time Days
8
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
John Haanen
Contact Person Email
j.haanen@nki.nl
Site Name
Medisch Centrum Leeuwarden B.V.
Department Name
Oncologisch Centrum Leeuwarden
Contact Person Name
Marco-Ben Polee
Contact Person Email
m.polee@mcl.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Interne Oncologie
Contact Person Name
Astrid van der Veldt
Contact Person Email
interne.oncologie@erasmusmc.nl
Site Name
Haga Hospital
Department Name
Interne Geneeskunde
Contact Person Name
Danny Houtsma
Contact Person Email
d.houtsma@hagaziekenhuis.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Interne Geneeskunde
Contact Person Name
Paul Hamberg
Contact Person Email
p.hamberg@franciscus.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
UMC Utrecht Cancer Center
Contact Person Name
Britt Suelmann
Contact Person Email
oncostudies@umcutrecht.nl
Site Name
Amphia Hospital
Department Name
Oncologie
Contact Person Name
Hans Westgeest
Contact Person Email
HWestgeest@amphia.nl
Site Name
Zuyderland Medisch Centrum Stichting
Department Name
Interne Geneeskunde
Contact Person Name
Franchette van den Berkmortel

Czechia

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
27-03-2024
Processing Time Days
14
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Fakultni Thomayerova nemocnice
Department Name
Onkologická klinika
Contact Person Name
Tomáš Büchler
Contact Person Email
tomas.buchler@ftn.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
Klinika komplexní onkologické péče
Contact Person Name
Alexandr Poprach
Contact Person Email
poprach@mou.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
Klinika onkologie a radioterapie
Contact Person Name
Jindřich Kopecký
Contact Person Email
jindrich.kopecky@fnhk.cz

France

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
24-05-2024
Processing Time Days
72
Number Of Sites
9
Number Of Participants
58

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Oncologie Médicale
Contact Person Name
Philippe Barthélémy
Contact Person Email
p.bathelemy@icans.eu
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Oncologie Médicale
Contact Person Name
Marine Gross-Goupil
Site Name
Hopital Tenon
Department Name
Oncologie Médicale
Contact Person Name
Ahmed Khalil
Contact Person Email
ahmed.khalil@aphp.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie Médicale
Contact Person Name
Sophie Abadie-Lacourtoisie
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
Oncologie Médicale
Contact Person Name
Loïc Mourey
Contact Person Email
mourey.loic@iuct-oncolpole.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncologie Médicale
Contact Person Name
Frederic Rolland
Site Name
Polyclinique De Limoges
Department Name
Oncologie Médicale
Contact Person Name
Sabrina Falkowsky
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie Médicale
Contact Person Name
Delphine Borchiellini
Site Name
Institut Godinot
Department Name
Oncologie Médicale
Contact Person Name
Jean-Christophe Eymard
Contact Person Email
jc.eymard@reims.unicancer.fr

Italy

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
28-03-2024
Processing Time Days
15
Number Of Sites
10
Number Of Participants
36

Sites

Site Name
Istituti Clinici Scientifici Maugeri
Department Name
Dipartimento Oncologia Medica
Contact Person Name
Andrea Premoli
Contact Person Email
andrea.premoli@icsmaugeri.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC di Oncologia Medica
Contact Person Name
Roberto Iacovelli
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Oncologia Medica Genitourinaria
Contact Person Name
Andrea Necchi
Contact Person Email
necchi.andrea@hsr.it
Site Name
Azienda USL Toscana Sud Est
Department Name
U.O.C. Oncologia Medica
Contact Person Name
Alketa Hamzaj
Site Name
Humanitas Research Hospital
Department Name
Oncologia medica ed Ematologia
Contact Person Name
Armando Santoro
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
SS Oncologia Medica Genitourinaria
Contact Person Name
Elena Verzoni
Site Name
University Hospital Consorziale Policlinico
Department Name
Oncologia medica
Contact Person Name
Camillo Porta
Contact Person Email
camillo.porta@uniba.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST
Department Name
OncologiaClinica e Sperimentale
Contact Person Name
Cristian Lolli
Contact Person Email
cristian.lolli@irst.emr.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncologia Medica
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
SC Oncologia
Contact Person Name
Annalisa Guida
Contact Person Email
a.guida@aospterni.it

Germany

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
12
Number Of Sites
8
Number Of Participants
27

Sites

Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Urologie
Contact Person Name
Markus Grabbert
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Urologie
Contact Person Name
Maria de Santis
Contact Person Email
uro-onkologie@charite.de
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Klinik für Urologie
Contact Person Name
Florian Seseke
Contact Person Email
Florian.Seseke@Martha-Maria.de
Site Name
Klinikum Nuernberg
Department Name
Hämatologie und Internistische Onkologie
Contact Person Name
Marinela Augustin
Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Abteilung für Urologie
Contact Person Name
Thomas Steiner
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Klinik für Onkologie und Palliativmedizin
Contact Person Name
Peter Reichardt
Site Name
National Center For Tumor Diseases (NCT) Heidelberg
Department Name
NCT Trial Center
Contact Person Name
Stefanie Zschäbitz
Site Name
Universitaetsklinikum Frankfurt AöR
Department Name
Zentrum der Chirugie - Klinik für Urologie
Contact Person Name
Clara Humke
Contact Person Email
clara.humke@unimedizin-ffm.de

Poland

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
02-04-2024
Processing Time Days
20
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie (Krakow)
Department Name
Oddział w Krakowie, Klinika Onkologii Klinicznej
Contact Person Name
Marek Ziobro
Site Name
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Department Name
Ambulatorium Chemioterapii
Contact Person Name
Bogdan Zurawski
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie (Warsaw)
Department Name
Klinika Nowotworów Układu Moczowego
Contact Person Name
Paweł Wiechno
Contact Person Email
badaniakliniczne@nio.gov.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Klinika Onkologii, Oddział Chemioterapii
Contact Person Name
Piotr Tomczak
Contact Person Email
zuzanna.tomczak@usk.poznan.pl

Spain

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
08-04-2024
Processing Time Days
26
Number Of Sites
8
Number Of Participants
66

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncology
Contact Person Name
Jose Arranz Arija
Contact Person Email
jarranza.oncomed@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncology
Contact Person Name
Begoña Pérez Valderrama
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Javier Puente Vázquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Jose Maroto Rey
Contact Person Email
jmaroto@santpau.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncology
Contact Person Name
Cristina Suarez Rodriguez
Contact Person Email
csuarez@vhio.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Guillermo Velasco Oria de Rueda
Contact Person Email
gdvelasco.gdv@gmail.com
Site Name
Hospital Clinic De Barcelona (second site listed)
Department Name
Oncology
Contact Person Name
Oscar Reig Torras
Contact Person Email
oreig@clinic.cat

Romania

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
28-03-2024
Processing Time Days
15
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Departament Oncologie Medicala
Contact Person Name
Michael Schenker
Contact Person Email
office@centruldeoncologie.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Departament Oncologie Medicala
Contact Person Name
Tudor Ciuleanu
Contact Person Email
office@iocn.ro
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca (second listed)
Department Name
Departament Oncologie Medicala
Contact Person Name
Cristina Cebotaru
Contact Person Email
office@iocn.ro

Belgium

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
10-04-2024
Processing Time Days
28
Number Of Sites
5
Number Of Participants
26

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Medische Oncologie
Contact Person Name
Sylvie Rottey
Contact Person Email
sylvie.rottey@ugent.be
Site Name
Grand Hopital De Charleroi
Department Name
Recherche-Clinique Oncologie - Hématologie
Contact Person Name
Marco Gizzi
Contact Person Email
marco.gizzi@ghdc.be
Site Name
UZ Leuven
Department Name
Algemene Medische Oncologie
Contact Person Name
Benoit Beuselinck
Contact Person Email
benoit.beuselinck@uzleuven.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Urology-Oncology
Contact Person Name
Jean-Pascal Machiels
Site Name
Institut Jules Bordet
Department Name
Clinical Trials Conduct Unit
Contact Person Name
Spyridon Sideris
Contact Person Email
spyridon.sideris@bordet.be

Austria

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
08-04-2024
Processing Time Days
26
Number Of Sites
3
Number Of Participants
18

Sites

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

Sponsor

Primary sponsor

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

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
Central imaging
Name
Pharmaceutical Product Development LLC (PPD)
Responsibilities
code 4 (sponsor duties)
Name
PPD Global Central Labs
Responsibilities
code 4 (central labs)
Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Almac
Responsibilities
code 3
Name
Medidata Solutions Inc.
Responsibilities
code 7

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging (sponsorDuties code 15, value: Central imaging)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services) (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Eisai

Investigational products

Investigational Product Name
Belzutifan
Active Substance
BELZUTIFAN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus:1
Maximum Dose
120 mg (maxDailyDoseAmount)
Investigational Product Name
Lenvatinib
Active Substance
LENVATINIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus:1
Maximum Dose
20 mg (maxDailyDoseAmount)
Investigational Product Name
Cabozantinib
Active Substance
CABOZANTINIB
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
prodAuthStatus:2
Maximum Dose
60 mg (maxDailyDoseAmount)
Combination Treatment
Yes

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